Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-29 @ 5:52 AM
Study NCT ID:
NCT00597935
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2008-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mgantz@rti.org', 'phone': '919-597-5110', 'title': 'Marie Gantz', 'organization': 'RTI International'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '24 Months', 'eventGroups': [{'id': 'EG000', 'title': 'ULS+BPMT', 'description': 'Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training', 'otherNumAtRisk': 91, 'otherNumAffected': 62, 'seriousNumAtRisk': 91, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'SSLF+BPMT', 'description': 'Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training', 'otherNumAtRisk': 95, 'otherNumAffected': 69, 'seriousNumAtRisk': 95, 'seriousNumAffected': 15}, {'id': 'EG002', 'title': 'ULS+USUAL', 'description': 'Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training', 'otherNumAtRisk': 97, 'otherNumAffected': 73, 'seriousNumAtRisk': 97, 'seriousNumAffected': 16}, {'id': 'EG003', 'title': 'SSLF+USUAL', 'description': 'Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training', 'otherNumAtRisk': 91, 'otherNumAffected': 62, 'seriousNumAtRisk': 91, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'OTHER ADVERSE EVENTS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'MESH EROSION/EXPOSURE AT 4 WEEKS TO 24 MONTHS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'SUTURE EXPOSURE AT 6 TO 24 MONTHS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'BLADDER INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'BLOOD TRANSFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'INTRAOPERTIVE URETERAL INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'RECTAL INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'TREATMENT - STENT PLACEMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'TREATMENT - SUTURE REMOVED INTRAOPERATIVELY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'URETERAL INJURY - DELAYED RECOGNITION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'NEUROLOGIC PAIN REQUIRING TREATMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'VAGINAL GRANULATION TISSUE AT 6 TO 24 MONTHS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'seriousEvents': [{'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Faecaloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hiatal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Oesophageal achalasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Suprapubic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Unable to determine Preferred Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Biliary cholic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'CHOLELITHIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Non-alcoholic steatohepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Allergic Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cholecystitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'DIVERTICULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pelvic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Unable to determine Preferred Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vaginal Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Anaemia postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Depression Suicidal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Mental 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'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Breast enlargement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ovarian vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Knee arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nephrectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Prolapse repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '0.00'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Surgical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SSLF+BPMT', 'description': 'Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG001', 'title': 'SSLF+USUAL', 'description': 'Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG002', 'title': 'ULS+BPMT', 'description': 'Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG003', 'title': 'ULS+USUAL', 'description': 'Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training'}], 'classes': [{'categories': [{'title': 'Failure', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}, {'title': 'Success', 'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months', 'description': "The absence of the following: (1) descent of the vaginal apex more than one-third into the vaginal canal; (2) anterior or posterior vaginal wall descent beyond the hymen; (3) bothersome vaginal bulge symptoms as indicated by an affirmative response to either 'Do you usually have a sensation of bulging or protrusion from the vaginal area?' or 'Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?' in the Pelvic Floor Distress Inventory and any response other than 'not at all' to the question 'How much does this bother you?'; or (4) re-treatment for prolapse by either surgery or pessary.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are minor differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data.'}, {'type': 'PRIMARY', 'title': 'Anatomic Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SSLF+BPMT', 'description': 'Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG001', 'title': 'SSLF+USUAL', 'description': 'Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG002', 'title': 'ULS+BPMT', 'description': 'Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG003', 'title': 'ULS+USUAL', 'description': 'Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training'}], 'classes': [{'categories': [{'title': 'Failure', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}, {'title': 'Non-failure', 'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months', 'description': 'Anatomic failure is defined by one of the following: descent of the vaginal apex more than one-third into the vaginal canal, anterior or posterior vaginal wall descent beyond the hymen, or re-treatment for prolapse.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is analyzed in participants randomized to both surgical and behavioral interventions and who were in the study at 24 months.'}, {'type': 'PRIMARY', 'title': 'Urinary Distress Inventory at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}, {'value': '88', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SSLF+BPMT', 'description': 'Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG001', 'title': 'SSLF+USUAL', 'description': 'Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG002', 'title': 'ULS+BPMT', 'description': 'Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG003', 'title': 'ULS+USUAL', 'description': 'Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training'}], 'classes': [{'categories': [{'measurements': [{'value': '30.6', 'groupId': 'OG000', 'lowerLimit': '22.8', 'upperLimit': '38.5'}, {'value': '37.9', 'groupId': 'OG001', 'lowerLimit': '27', 'upperLimit': '48.8'}, {'value': '27.4', 'groupId': 'OG002', 'lowerLimit': '19.1', 'upperLimit': '35.7'}, {'value': '29.7', 'groupId': 'OG003', 'lowerLimit': '21.3', 'upperLimit': '38.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (POPDI, with 3 subscales), 2. Colorectal Anal Distress Inventory (CRADI, with 4 subscales), and 3. Urinary Distress Inventory (UDI, with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the UDI is: 0-300 with 0 (least distress) to 300 (most distress). Lower scores indicate better function / fewer symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 6-month outcome. There are minor differences between the Number of Participants Analyzed and the 6-month numbers in the Participant Flow module because of missing data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline: Urinary Distress Inventory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SSLF+BPMT', 'description': 'Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG001', 'title': 'SSLF+USUAL', 'description': 'Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG002', 'title': 'ULS+BPMT', 'description': 'Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG003', 'title': 'ULS+USUAL', 'description': 'Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training'}], 'classes': [{'categories': [{'measurements': [{'value': '-88.1', 'groupId': 'OG000', 'lowerLimit': '-104.4', 'upperLimit': '-71.8'}, {'value': '-84.9', 'groupId': 'OG001', 'lowerLimit': '-99.3', 'upperLimit': '-70.5'}, {'value': '-82.5', 'groupId': 'OG002', 'lowerLimit': '-98.1', 'upperLimit': '-66.9'}, {'value': '-82.9', 'groupId': 'OG003', 'lowerLimit': '-97', 'upperLimit': '-68.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 months', 'description': 'The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (POPDI, with 3 subscales), 2. Colorectal Anal Distress Inventory (CRADI, with 4 subscales), and 3. Urinary Distress Inventory (UDI, with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the UDI is: 0-300 with 0 (least distress) to 300 (most distress). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline: Pelvic Organ Prolapse Distress Inventory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SSLF+BPMT', 'description': 'Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG001', 'title': 'SSLF+USUAL', 'description': 'Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG002', 'title': 'ULS+BPMT', 'description': 'Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG003', 'title': 'ULS+USUAL', 'description': 'Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training'}], 'classes': [{'categories': [{'measurements': [{'value': '-77.4', 'groupId': 'OG000', 'lowerLimit': '-93.7', 'upperLimit': '-61.1'}, {'value': '-70.6', 'groupId': 'OG001', 'lowerLimit': '-87.9', 'upperLimit': '-53.4'}, {'value': '-79.3', 'groupId': 'OG002', 'lowerLimit': '-96.6', 'upperLimit': '-62'}, {'value': '-66.4', 'groupId': 'OG003', 'lowerLimit': '-80.8', 'upperLimit': '-52.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 months', 'description': 'The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (POPDI, with 3 subscales), 2. Colorectal Anal Distress Inventory (CRADI, with 4 subscales), and 3. Urinary Distress Inventory (UDI, with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the POPDI is: 0-300 with 0 (least distress) to 300 (most distress). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline: Colorectal Anal Distress Inventory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SSLF+BPMT', 'description': 'Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG001', 'title': 'SSLF+USUAL', 'description': 'Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG002', 'title': 'ULS+BPMT', 'description': 'Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG003', 'title': 'ULS+USUAL', 'description': 'Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training'}], 'classes': [{'categories': [{'measurements': [{'value': '-48.6', 'groupId': 'OG000', 'lowerLimit': '-68.9', 'upperLimit': '-28.2'}, {'value': '-46.5', 'groupId': 'OG001', 'lowerLimit': '-66.1', 'upperLimit': '-26.8'}, {'value': '-61.4', 'groupId': 'OG002', 'lowerLimit': '-78.6', 'upperLimit': '-44.2'}, {'value': '-52.4', 'groupId': 'OG003', 'lowerLimit': '-70.2', 'upperLimit': '-34.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 months', 'description': 'The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (POPDI, with 3 subscales), 2. Colorectal Anal Distress Inventory (CRADI, with 4 subscales), and 3. Urinary Distress Inventory (UDI, with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the CRADI is: 0-400 with 0 (least distress) to 400 (most distress). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data.'}, {'type': 'SECONDARY', 'title': 'Urinary Impact Questionnaire Change From Baseline to 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SSLF+BPMT', 'description': 'Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG001', 'title': 'SSLF+USUAL', 'description': 'Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG002', 'title': 'ULS+BPMT', 'description': 'Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG003', 'title': 'ULS+USUAL', 'description': 'Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training'}], 'classes': [{'categories': [{'measurements': [{'value': '-84', 'groupId': 'OG000', 'lowerLimit': '-110.4', 'upperLimit': '-57.7'}, {'value': '-72.6', 'groupId': 'OG001', 'lowerLimit': '-94.4', 'upperLimit': '-50.8'}, {'value': '-79', 'groupId': 'OG002', 'lowerLimit': '-104.3', 'upperLimit': '-53.7'}, {'value': '-97.6', 'groupId': 'OG003', 'lowerLimit': '-119.5', 'upperLimit': '-75.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 months', 'description': "The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data.'}, {'type': 'SECONDARY', 'title': 'Pelvic Organ Prolapse Impact Questionnaire Change From Baseline to 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SSLF+BPMT', 'description': 'Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG001', 'title': 'SSLF+USUAL', 'description': 'Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG002', 'title': 'ULS+BPMT', 'description': 'Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG003', 'title': 'ULS+USUAL', 'description': 'Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training'}], 'classes': [{'categories': [{'measurements': [{'value': '-67.5', 'groupId': 'OG000', 'lowerLimit': '-94.6', 'upperLimit': '-40.4'}, {'value': '-49.1', 'groupId': 'OG001', 'lowerLimit': '-70.9', 'upperLimit': '-27.3'}, {'value': '-59.4', 'groupId': 'OG002', 'lowerLimit': '-86.1', 'upperLimit': '-32.6'}, {'value': '-82.2', 'groupId': 'OG003', 'lowerLimit': '-103.7', 'upperLimit': '-60.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 months', 'description': "The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year 2 Score - Baseline Score). Lower scores indicate better function / fewer symptoms.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data.'}, {'type': 'SECONDARY', 'title': 'Colorectal-Anal Impact Questionnaire Change From Baseline to 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SSLF+BPMT', 'description': 'Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG001', 'title': 'SSLF+USUAL', 'description': 'Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG002', 'title': 'ULS+BPMT', 'description': 'Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG003', 'title': 'ULS+USUAL', 'description': 'Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training'}], 'classes': [{'categories': [{'measurements': [{'value': '-40.9', 'groupId': 'OG000', 'lowerLimit': '-67.8', 'upperLimit': '-14'}, {'value': '-21.6', 'groupId': 'OG001', 'lowerLimit': '-41.8', 'upperLimit': '-1.4'}, {'value': '-29.2', 'groupId': 'OG002', 'lowerLimit': '-54', 'upperLimit': '-4.3'}, {'value': '-42.5', 'groupId': 'OG003', 'lowerLimit': '-60.7', 'upperLimit': '-24.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 months', 'description': "The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year 2 Score - Baseline Score). Lower scores indicate better function / fewer symptoms.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data.'}, {'type': 'SECONDARY', 'title': 'Sexual Function 36 - Physical Health Component Score Change From Baseline to 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SSLF+BPMT', 'description': 'Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG001', 'title': 'SSLF+USUAL', 'description': 'Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG002', 'title': 'ULS+BPMT', 'description': 'Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG003', 'title': 'ULS+USUAL', 'description': 'Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training'}], 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '10.4'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '2.4', 'upperLimit': '7.2'}, {'value': '4.8', 'groupId': 'OG002', 'lowerLimit': '2.6', 'upperLimit': '6.9'}, {'value': '6', 'groupId': 'OG003', 'lowerLimit': '4', 'upperLimit': '7.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 months', 'description': 'Sexual Function 36 (SF36) - Physical Health Component Score is the physical health component of the Sexual Function 36 survey with scores ranging from 0 to 100 with higher scores meaning a better health state. Scales are scored according to the algorithm that describes the handling of the various types of questions included in the questionnaire. Several steps are involved in the scoring process: recoding items that require it; summing over items; and transforming raw scale scores to a 0 to 100 scale. This physical health component is a function of several constructs measured under the SF36: physical functioning, physical role, bodily pain, general health, and vitality.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data.'}, {'type': 'SECONDARY', 'title': 'Sexual Function 36 - Mental Health Component Score Change From Baseline to 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SSLF+BPMT', 'description': 'Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG001', 'title': 'SSLF+USUAL', 'description': 'Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG002', 'title': 'ULS+BPMT', 'description': 'Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG003', 'title': 'ULS+USUAL', 'description': 'Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '-2.2', 'upperLimit': '3.4'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '4.2'}, {'value': '2.5', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '1.1', 'groupId': 'OG003', 'lowerLimit': '-1.7', 'upperLimit': '4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 months', 'description': 'Sexual Function 36 (SF36) - Mental Health Component Score is the mental health component of the Sexual Function 36 survey with scores ranging from 0 to 100 with higher scores meaning a better health state. Scales are scored according to the algorithm that describes the handling of the various types of questions included in the questionnaire. Several steps are involved in the scoring process: recoding items that require it; summing over items; and transforming raw scale scores to a 0 to 100 scale.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data.'}, {'type': 'SECONDARY', 'title': 'Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire Change From Baseline to 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SSLF+BPMT', 'description': 'Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG001', 'title': 'SSLF+USUAL', 'description': 'Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG002', 'title': 'ULS+BPMT', 'description': 'Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'OG003', 'title': 'ULS+USUAL', 'description': 'Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '8.2'}, {'value': '4.6', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '7.8'}, {'value': '3.8', 'groupId': 'OG002', 'lowerLimit': '0.9', 'upperLimit': '6.6'}, {'value': '6.6', 'groupId': 'OG003', 'lowerLimit': '4.2', 'upperLimit': '9.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 months', 'description': 'Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ) is a survey of sexual functioning with scores ranging from 0 to 48 with higher scores meaning better sexual functioning. Patients were asked to answer 31 questions about their sexuality in the past 6 months.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SSLF+BPMT', 'description': 'Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'FG001', 'title': 'SSLF+USUAL', 'description': 'Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'FG002', 'title': 'ULS+BPMT', 'description': 'Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'FG003', 'title': 'ULS+USUAL', 'description': 'Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training'}], 'periods': [{'title': 'Randomized to Surgical and BPMT Arms', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '91'}, {'groupId': 'FG002', 'numSubjects': '91'}, {'groupId': 'FG003', 'numSubjects': '97'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '91'}, {'groupId': 'FG002', 'numSubjects': '91'}, {'groupId': 'FG003', 'numSubjects': '97'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Baseline to 6-Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '91'}, {'groupId': 'FG002', 'numSubjects': '91'}, {'groupId': 'FG003', 'numSubjects': '97'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '87'}, {'groupId': 'FG002', 'numSubjects': '87'}, {'groupId': 'FG003', 'numSubjects': '93'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}]}, {'title': '6-Months to 24-Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '87'}, {'groupId': 'FG002', 'numSubjects': '87'}, {'groupId': 'FG003', 'numSubjects': '93'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '79'}, {'groupId': 'FG002', 'numSubjects': '77'}, {'groupId': 'FG003', 'numSubjects': '85'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '97', 'groupId': 'BG003'}, {'value': '374', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'SSLF+BPMT', 'description': 'Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'BG001', 'title': 'SSLF+USUAL', 'description': 'Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'BG002', 'title': 'ULS+BPMT', 'description': 'Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'BG003', 'title': 'ULS+USUAL', 'description': 'Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.3', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '58.1', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '58.7', 'spread': '10.5', 'groupId': 'BG002'}, {'value': '55.8', 'spread': '11', 'groupId': 'BG003'}, {'value': '57.2', 'spread': '10.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '97', 'groupId': 'BG003'}, {'value': '374', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}, {'title': 'Other', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}, {'value': '315', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic/Latina', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '75', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic/Latina', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}, {'value': '299', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Insurance: Private/HMO', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '123', 'groupId': 'BG004'}]}, {'title': 'Yes', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '251', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Insurance: Medicare or Medicaid', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}, {'value': '265', 'groupId': 'BG004'}]}, {'title': 'Yes', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '109', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Insurance: Self-pay', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}, {'value': '95', 'groupId': 'BG003'}, {'value': '368', 'groupId': 'BG004'}]}, {'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Insurance: Other', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}, {'value': '302', 'groupId': 'BG004'}]}, {'title': 'Yes', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '72', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '30', 'spread': '6.2', 'groupId': 'BG000'}, {'value': '28', 'spread': '5.1', 'groupId': 'BG001'}, {'value': '28.6', 'spread': '4.9', 'groupId': 'BG002'}, {'value': '28.8', 'spread': '5.5', 'groupId': 'BG003'}, {'value': '28.8', 'spread': '5.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Current Smoker', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}, {'value': '341', 'groupId': 'BG004'}]}, {'title': 'Yes', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes', 'classes': [{'categories': [{'title': '.', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'No', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '87', 'groupId': 'BG003'}, {'value': '322', 'groupId': 'BG004'}]}, {'title': 'Yes', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Connective tissue disease', 'classes': [{'categories': [{'title': '.', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'No', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}, {'value': '364', 'groupId': 'BG004'}]}, {'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Vaginal Deliveries', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '12'}, {'value': '3', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '15'}, {'value': '3', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '3', 'groupId': 'BG004', 'lowerLimit': '0', 'upperLimit': '15'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Number of deliveries', 'dispersionType': 'FULL_RANGE'}, {'title': 'Number of Cesarean Deliveries', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '0', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'BG004', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Number of deliveries', 'dispersionType': 'FULL_RANGE'}, {'title': 'Estrogen Use: Oral or patch', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}, {'value': '328', 'groupId': 'BG004'}]}, {'title': 'Yes', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Estrogen Use: Vaginal', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}, {'title': 'Yes', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '88', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Menstrual Status', 'classes': [{'categories': [{'title': 'Not sure', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}, {'title': 'Postmenopausal', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '246', 'groupId': 'BG004'}]}, {'title': 'Premenopausal', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '106', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hysterectomy', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '274', 'groupId': 'BG004'}]}, {'title': 'Yes', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior Stress Urinary Incontinence Surgery', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}, {'value': '361', 'groupId': 'BG004'}]}, {'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior Pelvic Organ Prolapse Surgery', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}, {'value': '348', 'groupId': 'BG004'}]}, {'title': 'Yes', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pelvic Organ Prolapse-Q stage', 'classes': [{'categories': [{'title': '2', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '144', 'groupId': 'BG004'}]}, {'title': '3', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '212', 'groupId': 'BG004'}]}, {'title': '4', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The POP-Q assessment is a tool that measure the severity of prolapse. It measures nine points in the vagina with the hymen being the reference point. The distance to the reference point (in cm) is measured for the prolapsed and the severity stage is calculated. Higher stages indicate worse prolapse.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 374}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-21', 'studyFirstSubmitDate': '2008-01-09', 'resultsFirstSubmitDate': '2020-09-01', 'studyFirstSubmitQcDate': '2008-01-09', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-21', 'studyFirstPostDateStruct': {'date': '2008-01-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical Success', 'timeFrame': '24 months', 'description': "The absence of the following: (1) descent of the vaginal apex more than one-third into the vaginal canal; (2) anterior or posterior vaginal wall descent beyond the hymen; (3) bothersome vaginal bulge symptoms as indicated by an affirmative response to either 'Do you usually have a sensation of bulging or protrusion from the vaginal area?' or 'Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?' in the Pelvic Floor Distress Inventory and any response other than 'not at all' to the question 'How much does this bother you?'; or (4) re-treatment for prolapse by either surgery or pessary."}, {'measure': 'Anatomic Failure', 'timeFrame': '24 months', 'description': 'Anatomic failure is defined by one of the following: descent of the vaginal apex more than one-third into the vaginal canal, anterior or posterior vaginal wall descent beyond the hymen, or re-treatment for prolapse.'}, {'measure': 'Urinary Distress Inventory at 6 Months', 'timeFrame': '6 months', 'description': 'The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (POPDI, with 3 subscales), 2. Colorectal Anal Distress Inventory (CRADI, with 4 subscales), and 3. Urinary Distress Inventory (UDI, with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the UDI is: 0-300 with 0 (least distress) to 300 (most distress). Lower scores indicate better function / fewer symptoms.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline: Urinary Distress Inventory', 'timeFrame': 'Baseline and 24 months', 'description': 'The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (POPDI, with 3 subscales), 2. Colorectal Anal Distress Inventory (CRADI, with 4 subscales), and 3. Urinary Distress Inventory (UDI, with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the UDI is: 0-300 with 0 (least distress) to 300 (most distress). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms.'}, {'measure': 'Change From Baseline: Pelvic Organ Prolapse Distress Inventory', 'timeFrame': 'Baseline and 24 months', 'description': 'The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (POPDI, with 3 subscales), 2. Colorectal Anal Distress Inventory (CRADI, with 4 subscales), and 3. Urinary Distress Inventory (UDI, with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the POPDI is: 0-300 with 0 (least distress) to 300 (most distress). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms.'}, {'measure': 'Change From Baseline: Colorectal Anal Distress Inventory', 'timeFrame': 'Baseline and 24 months', 'description': 'The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (POPDI, with 3 subscales), 2. Colorectal Anal Distress Inventory (CRADI, with 4 subscales), and 3. Urinary Distress Inventory (UDI, with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the CRADI is: 0-400 with 0 (least distress) to 400 (most distress). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms.'}, {'measure': 'Urinary Impact Questionnaire Change From Baseline to 24 Months', 'timeFrame': 'Baseline and 24 months', 'description': "The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms."}, {'measure': 'Pelvic Organ Prolapse Impact Questionnaire Change From Baseline to 24 Months', 'timeFrame': 'Baseline and 24 months', 'description': "The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year 2 Score - Baseline Score). Lower scores indicate better function / fewer symptoms."}, {'measure': 'Colorectal-Anal Impact Questionnaire Change From Baseline to 24 Months', 'timeFrame': 'Baseline and 24 months', 'description': "The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year 2 Score - Baseline Score). Lower scores indicate better function / fewer symptoms."}, {'measure': 'Sexual Function 36 - Physical Health Component Score Change From Baseline to 24 Months', 'timeFrame': 'Baseline and 24 months', 'description': 'Sexual Function 36 (SF36) - Physical Health Component Score is the physical health component of the Sexual Function 36 survey with scores ranging from 0 to 100 with higher scores meaning a better health state. Scales are scored according to the algorithm that describes the handling of the various types of questions included in the questionnaire. Several steps are involved in the scoring process: recoding items that require it; summing over items; and transforming raw scale scores to a 0 to 100 scale. This physical health component is a function of several constructs measured under the SF36: physical functioning, physical role, bodily pain, general health, and vitality.'}, {'measure': 'Sexual Function 36 - Mental Health Component Score Change From Baseline to 24 Months', 'timeFrame': 'Baseline and 24 months', 'description': 'Sexual Function 36 (SF36) - Mental Health Component Score is the mental health component of the Sexual Function 36 survey with scores ranging from 0 to 100 with higher scores meaning a better health state. Scales are scored according to the algorithm that describes the handling of the various types of questions included in the questionnaire. Several steps are involved in the scoring process: recoding items that require it; summing over items; and transforming raw scale scores to a 0 to 100 scale.'}, {'measure': 'Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire Change From Baseline to 24 Months', 'timeFrame': 'Baseline and 24 months', 'description': 'Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ) is a survey of sexual functioning with scores ranging from 0 to 48 with higher scores meaning better sexual functioning. Patients were asked to answer 31 questions about their sexuality in the past 6 months.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['prolapse', 'urinary incontinence', 'uterosacral vaginal vault ligament suspension', 'sacrospinous ligament fixation', 'behavioral therapy', 'pelvic muscle training'], 'conditions': ['Pelvic Organ Prolapse (POP)']}, 'referencesModule': {'references': [{'pmid': '19130903', 'type': 'BACKGROUND', 'citation': 'Barber MD, Brubaker L, Menefee S, Norton P, Borello-France D, Varner E, Schaffer J, Weidner A, Xu X, Spino C, Weber A; Pelvic Floor Disorders Network. Operations and pelvic muscle training in the management of apical support loss (OPTIMAL) trial: design and methods. Contemp Clin Trials. 2009 Mar;30(2):178-89. doi: 10.1016/j.cct.2008.12.001. Epub 2008 Dec 16.'}, {'pmid': '37318279', 'type': 'DERIVED', 'citation': 'Borello-France D, Newman DK, Markland AD, Propst K, Jelovsek JE, Cichowski S, Gantz MG, Balgobin S, Jakus-Waldman S, Korbly N, Mazloomdoost D, Burgio KL; NICHD Pelvic Floor Disorders Network. Adherence to Perioperative Behavioral Therapy With Pelvic Floor Muscle Training in Women Receiving Vaginal Reconstructive Surgery for Pelvic Organ Prolapse. Phys Ther. 2023 Sep 1;103(9):pzad059. doi: 10.1093/ptj/pzad059.'}, {'pmid': '33030871', 'type': 'DERIVED', 'citation': 'Jakus-Waldman S, Brubaker L, Jelovsek JE, Schaffer JI, Ellington DR, Mazloomdoost D, Whitworth R, Gantz MG; NICHD Pelvic Floor Disorders Network (PFDN). Risk Factors for Surgical Failure and Worsening Pelvic Floor Symptoms Within 5 Years After Vaginal Prolapse Repair. Obstet Gynecol. 2020 Nov;136(5):933-941. doi: 10.1097/AOG.0000000000004092.'}, {'pmid': '32769645', 'type': 'DERIVED', 'citation': 'Lukacz ES, Sridhar A, Chermansky CJ, Rahn DD, Harvie HS, Gantz MG, Varner RE, Korbly NB, Mazloomdoost D; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network (PFDN). Sexual Activity and Dyspareunia 1 Year After Surgical Repair of Pelvic Organ Prolapse. Obstet Gynecol. 2020 Sep;136(3):492-500. doi: 10.1097/AOG.0000000000003992.'}, {'pmid': '31449806', 'type': 'DERIVED', 'citation': 'Sutkin G, Zyczynski HM, Sridhar A, Jelovsek JE, Rardin CR, Mazloomdoost D, Rahn DD, Nguyen JN, Andy UU, Meyer I, Gantz MG; NICHD Pelvic Floor Disorders Network. Association between adjuvant posterior repair and success of native tissue apical suspension. Am J Obstet Gynecol. 2020 Feb;222(2):161.e1-161.e8. doi: 10.1016/j.ajog.2019.08.024. Epub 2019 Aug 23.'}, {'pmid': '27159758', 'type': 'DERIVED', 'citation': 'Lukacz ES, Warren LK, Richter HE, Brubaker L, Barber MD, Norton P, Weidner AC, Nguyen JN, Gantz MG. Quality of Life and Sexual Function 2 Years After Vaginal Surgery for Prolapse. Obstet Gynecol. 2016 Jun;127(6):1071-1079. doi: 10.1097/AOG.0000000000001442.'}, {'pmid': '24618964', 'type': 'DERIVED', 'citation': 'Barber MD, Brubaker L, Burgio KL, Richter HE, Nygaard I, Weidner AC, Menefee SA, Lukacz ES, Norton P, Schaffer J, Nguyen JN, Borello-France D, Goode PS, Jakus-Waldman S, Spino C, Warren LK, Gantz MG, Meikle SF; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: the OPTIMAL randomized trial. JAMA. 2014 Mar 12;311(10):1023-34. doi: 10.1001/jama.2014.1719.'}, {'pmid': '22777368', 'type': 'DERIVED', 'citation': 'Barber MD, Kenton K, Janz NK, Hsu Y, Dyer KY, Greer WJ, White A, Meikle S, Ye W. Validation of the activities assessment scale in women undergoing pelvic reconstructive surgery. Female Pelvic Med Reconstr Surg. 2012 Jul-Aug;18(4):205-10. doi: 10.1097/SPV.0b013e31825e6422.'}, {'pmid': '22777367', 'type': 'DERIVED', 'citation': 'Barber MD, Janz N, Kenton K, Hsu Y, Greer WJ, Dyer K, White A, Meikle S, Ye W. Validation of the surgical pain scales in women undergoing pelvic reconstructive surgery. Female Pelvic Med Reconstr Surg. 2012 Jul-Aug;18(4):198-204. doi: 10.1097/SPV.0b013e31825d65aa.'}]}, 'descriptionModule': {'briefSummary': 'Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Pelvic organ prolapse often involves a combination of support defects involving the anterior, posterior and/or apical vaginal segments. While the anterior vaginal wall is the segment most likely to demonstrate recurrent prolapse after reconstructive surgery, reoperations are highest among those who require apical suspension procedures with or without repair of other vaginal segments (12%-33%). Despite the substantial health impact, there is a paucity of high quality evidence to support different practices in the management of prolapse, particularly surgery. Thus, the objectives of the Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) Trial are:\n\n1. to compare sacrospinous ligament fixation (SSLF) to uterosacral vaginal vault ligament suspension (ULS); and\n2. to assess the role of perioperative behavioral therapy/pelvic muscle training (PMT) in women undergoing vaginal surgery for apical or uterine prolapse and stress urinary incontinence.', 'detailedDescription': "Many women develop pelvic organ prolapse over the course of their lives. Pelvic organ prolapse is the downward descent of the pelvic organs (which include the uterus, bladder and bowel) into the vagina. Researchers estimate that between 7-10% of women will require surgery for prolapse sometime in their lifetime. Many will have more than one operation for the prolapse. Because this is such a common problem, the investigators in the Pelvic Floor Disorders Network strive to offer women the best treatment options. However, there were not enough carefully designed and conducted research studies to help guide them in this direction.\n\nWomen who are planning surgery for apical vaginal prolapse often experience bladder and bowel symptoms, as well as pressure and a bulge. These symptoms might include urinary leakage (urinary incontinence), urinary urgency (a sudden strong desire to urinate with fear that leakage may occur) or frequent urination, difficulty starting to urinate or perhaps a slow weak urinary stream, as well as accidental bowel leakage (fecal incontinence). After surgery, bladder and bowel symptoms may get better, get worse, or stay the same as before surgery. Sometimes new symptoms can start after surgery even if they weren't present before surgery.\n\nThe OPTIMAL study was designed to compare two commonly performed vaginal surgeries for pelvic organ prolapse. One is the sacrospinous ligament fixation, called SSLF for short. The other is the uterosacral ligament suspension, called ULS. Both surgeries involve attaching the top of the vagina, which has fallen down, to internal ligaments in the pelvis in order to resuspend the vagina and correct the prolapse.\n\nThe investigators were also interested in studying how the surgeries altered bladder and bowel symptoms. They had seen in other studies that behavioral and pelvic floor muscle therapy (PMT) is an effective therapy for stress and urge urinary incontinence, fecal incontinence, and other pelvic floor disorders. It is relatively easy to perform, and has rare side effects. They wondered if PMT around the time of surgery might further improve these symptoms.\n\nThe OPTIMAL study has two main purposes:\n\n1. To find out which type of surgery, SSLF or ULS, has better results when used to repair prolapse of the top of the vagina,\n2. To find out whether or not doing pelvic muscle exercises and behavioral changes around the time of surgery will affect both bladder and bowel symptoms after surgery, and the success of the prolapse repair.\n\nFour Hundred women were enrolled into the OPTIMAL study, from January 2008 to May 2011. These women were randomly assigned to receive either the SSLF or the ULS surgery. They were randomly assigned to either receive the PMT training with a therapist before and after surgery or to not receive this therapy. So women fell into one of four groups:\n\n1. SSLF plus PMT\n2. ULS plus PMT\n3. SSLF without PMT\n4. ULS without PMT\n\nWomen in this study were followed closely at regular intervals for two years after surgery."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stage 2 to 4 prolapse\n* Prolapse of the vaginal apex or cervix to at least half way into the vaginal canal (POPQ Point C \\> -TVL/2) \\[TVL stands for total vaginal length\\]\n* Vaginal bulge symptoms as indicated by an affirmative response to either questions on the Pelvic Floor Distress Inventory (PFDI)\n* Vaginal surgery for prolapse is planned, including a vaginal apical suspension procedure.\n* Stress incontinence symptoms as indicated by an affirmative response to the PFDI Stress incontinence subscale\n* Documentation of transurethral stress leakage on an office stress test or urodynamics with or without prolapse reduction within the previous 12 months\n* A tension free vaginal tape (TVT) is planned to treat stress urinary incontinence.\n* A pelvic muscle training (PMT) visit can be performed at least 2 weeks and not more than 4 weeks before surgery.\n* Available for 24-months of follow-up.\n* Able to complete study assessments, per clinician judgment\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Contraindication to sacrospinous ligament fixation (SSLF), uterosacral vaginal vault ligament suspension (ULS), or TVT in the opinion of the treating surgeon.\n* History of previous surgery that included a SSLF or ULS. (Previous vaginal vault suspensions using other techniques or in which the previous technique is unknown are eligible.)\n* Pelvic pain or dyspareunia due to levator ani spasm that would preclude a PMT program.\n* History of previous synthetic sling procedure for stress incontinence.\n* Previous adverse reaction to synthetic mesh.\n* Urethral diverticulum, current or previous (i.e., repaired)\n* History of femoral to femoral bypass.\n* Current cytotoxic chemotherapy or current or history of pelvic radiation therapy.\n* History of two inpatient hospitalizations for medical comorbidities in the previous 12 months.\n* Subject wishes to retain her uterus. \\[Both ULS and SLS include removal of the uterus, if not previously removed\\]'}, 'identificationModule': {'nctId': 'NCT00597935', 'acronym': 'OPTIMAL', 'briefTitle': 'Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial', 'organization': {'class': 'NETWORK', 'fullName': 'NICHD Pelvic Floor Disorders Network'}, 'officialTitle': 'Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial: A Randomized Trial of Sacrospinous Ligament Fixation (SSLF) Versus Uterosacral Ligament Suspension (ULS) With and Without Perioperative Behavioral Therapy/Pelvic Muscle Training', 'orgStudyIdInfo': {'id': '16P01'}, 'secondaryIdInfos': [{'id': '2U01HD041249', 'link': 'https://reporter.nih.gov/quickSearch/2U01HD041249', 'type': 'NIH'}, {'id': '2U10HD041250', 'link': 'https://reporter.nih.gov/quickSearch/2U10HD041250', 'type': 'NIH'}, {'id': '2U10HD041261', 'link': 'https://reporter.nih.gov/quickSearch/2U10HD041261', 'type': 'NIH'}, {'id': '2U10HD041267', 'link': 'https://reporter.nih.gov/quickSearch/2U10HD041267', 'type': 'NIH'}, {'id': '1U10HD054136', 'link': 'https://reporter.nih.gov/quickSearch/1U10HD054136', 'type': 'NIH'}, {'id': '1U10HD054214', 'link': 'https://reporter.nih.gov/quickSearch/1U10HD054214', 'type': 'NIH'}, {'id': '1U10HD054215', 'link': 'https://reporter.nih.gov/quickSearch/1U10HD054215', 'type': 'NIH'}, {'id': '1U10HD054241', 'link': 'https://reporter.nih.gov/quickSearch/1U10HD054241', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SSLF and PMT', 'description': 'Sacrospinous Ligament Fixation (SSLF) and Pelvic Muscle Training \\& Exercises (PMT)', 'interventionNames': ['Procedure: SSLF', 'Behavioral: PMT']}, {'type': 'EXPERIMENTAL', 'label': 'ULS and PMT', 'description': 'Uterosacral Vaginal Vault Ligament Suspension (ULS) and Pelvic Muscle Training \\& Exercises (PMT)', 'interventionNames': ['Procedure: ULS', 'Behavioral: PMT']}, {'type': 'EXPERIMENTAL', 'label': 'SSLF without PMT', 'description': 'Sacrospinous Ligament Fixation (SSLF) without Pelvic Muscle Training \\& Exercises (PMT)', 'interventionNames': ['Procedure: SSLF']}, {'type': 'EXPERIMENTAL', 'label': 'ULS without PMT', 'description': 'Uterosacral Vaginal Vault Ligament Suspension (ULS) without Pelvic Muscle Training \\& Exercises (PMT)', 'interventionNames': ['Procedure: ULS']}], 'interventions': [{'name': 'SSLF', 'type': 'PROCEDURE', 'description': 'sacrospinous ligament fixation (SSLF)', 'armGroupLabels': ['SSLF and PMT', 'SSLF without PMT']}, {'name': 'ULS', 'type': 'PROCEDURE', 'description': 'uterosacral vaginal vault ligament suspension (ULS)', 'armGroupLabels': ['ULS and PMT', 'ULS without PMT']}, {'name': 'PMT', 'type': 'BEHAVIORAL', 'description': 'Pelvic muscle training and exercises (PMT)', 'armGroupLabels': ['SSLF and PMT', 'ULS and PMT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233-7333', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'The University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90706', 'city': 'Bellflower', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Bellflower', 'geoPoint': {'lat': 33.88168, 'lon': -118.11701}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego Medical Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University Medical Center', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Matthew Barber, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NICHD Pelvic Floor Disorders Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}