Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-26 @ 6:44 PM
Study NCT ID:
NCT00460434
Status:
COMPLETED
Last Update Posted:
2018-05-30
First Post:
2007-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C005703', 'term': 'salicylhydroxamic acid'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mgantz@rti.org', 'phone': '919-597-5110', 'title': 'Marie Gantz', 'organization': 'RTI International'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 months after index surgery', 'eventGroups': [{'id': 'EG000', 'title': 'Midurethral Sling', 'description': 'Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.', 'otherNumAtRisk': 165, 'otherNumAffected': 92, 'seriousNumAtRisk': 165, 'seriousNumAffected': 28}, {'id': 'EG001', 'title': 'Sham Incision', 'description': 'Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.', 'otherNumAtRisk': 172, 'otherNumAffected': 63, 'seriousNumAtRisk': 172, 'seriousNumAffected': 20}], 'otherEvents': [{'term': 'Bladder perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 30}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Bladder retention at hospital discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 51}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Bladder retention at 2 weeks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}], 'seriousEvents': [{'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Congestive heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Pulse decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Abnormal electrocardiogram', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Fluid Overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Prolapse repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Rectal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Rectocele repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Anaemia postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Knee arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Mammogram abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Pain postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Vaginal haemorrhage postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}, {'term': 'Vaginal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(V19.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Failure Defined as Subsequent Treatment for Urinary Incontinence, Signs or Symptoms of Bothersome Urinary Incontinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Midurethral Sling', 'description': 'Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.'}, {'id': 'OG001', 'title': 'Sham Incision', 'description': 'Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months post-surgery', 'description': 'Defined as a positive cough stress test, bothersome incontinence symptoms, or treatment for urinary incontinence, and urinary incontinence (stress, urge, or mixed), regardless of whether interim treatment for incontinence had been provided.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Prevalence of Bothersome Urinary Incontinence at 12 Months Following Index Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Midurethral Sling', 'description': 'Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.'}, {'id': 'OG001', 'title': 'Sham Incision', 'description': 'Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months post-surgery', 'description': 'Defined as a positive cough stress test or report of bothersome incontinence symptoms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Medical Outcomes Study 36-Item Short Form Health Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Midurethral Sling', 'description': 'Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.'}, {'id': 'OG001', 'title': 'Sham Incision', 'description': 'Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.'}], 'classes': [{'title': '3 Months - Mental Component', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '9.25', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '8.44', 'groupId': 'OG001'}]}]}, {'title': '3 Months - Physical Component', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '8.21', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '7.52', 'groupId': 'OG001'}]}]}, {'title': '12 Months - Mental Component', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '8.94', 'groupId': 'OG001'}]}]}, {'title': '12 Months - Physical Component', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '9.23', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '7.51', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months, and 12 Months post-surgery', 'description': 'This survey is a generic health-related quality of life measure. Scores have normalized values with a mean of 50 and a standard deviation of 10, with higher scores indicating better health status. Results measure the average change in scores from baseline to follow-up.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Women who completed the Medical Outcomes Study 36-Item Short Form Health Survey at baseline and 3 and 12 months after the index surgery.'}, {'type': 'SECONDARY', 'title': 'Positive Cough Stress Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Midurethral Sling', 'description': 'Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.'}, {'id': 'OG001', 'title': 'Sham Incision', 'description': 'Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.'}], 'classes': [{'title': '3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': '12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 and 12 Months Post-surgery', 'description': 'A leakage of urine with coughing or straining in either the supine or standing position with the bladder filled through a urethral catheter to 300 ml.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Women who came in for 3 and 12 month post-op office visits and completed a cough stress test.'}, {'type': 'SECONDARY', 'title': 'Symptoms of Incontinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Midurethral Sling', 'description': 'Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.'}, {'id': 'OG001', 'title': 'Sham Incision', 'description': 'Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.'}], 'classes': [{'title': '3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': '12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 and 12 Months Post-surgery', 'description': 'Symptoms that were at least moderately bothersome to the participant (as measured by a response of "moderately" or "quite a bit" to any of the four items on the Pelvic Floor Distress Inventory regarding leakage).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Women who completed questions in the Pelvic Floor Distress Inventory regarding leakage 3 and 12 months after their index surgery.'}, {'type': 'SECONDARY', 'title': 'Treatment for Incontinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Midurethral Sling', 'description': 'Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.'}, {'id': 'OG001', 'title': 'Sham Incision', 'description': 'Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months post-surgery', 'description': 'The need for treatment for any urinary incontinence, including surgery, medication, pessary for incontinence, supervised pelvic-muscle exercises, timed voiding and fluid management, periurethral injection, botulinum toxin injection, neuromodulation, or other treatment for incontinence.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Women who reported whether or not they needed treatment for any urinary incontinence.'}, {'type': 'SECONDARY', 'title': 'Pelvic Floor Distress Inventory (PFDI) Urinary Distress Inventory (UDI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Midurethral Sling', 'description': 'Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.'}, {'id': 'OG001', 'title': 'Sham Incision', 'description': 'Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.'}], 'classes': [{'title': '3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-44.9', 'spread': '48.24', 'groupId': 'OG000'}, {'value': '-34.4', 'spread': '44.92', 'groupId': 'OG001'}]}]}, {'title': '12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-43.1', 'spread': '44.25', 'groupId': 'OG000'}, {'value': '-39.3', 'spread': '40.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months, and 12 months post-surgery', 'description': 'PFDI is a symptom inventory for pelvic floor disorders. Scores ranges from 0 to 300, with higher scores indicating more symptoms. Results measure the average change in scores from baseline to follow-up.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Women who completed the PFDI UDI survey at baseline and 3 and 12 months after the index surgery.'}, {'type': 'SECONDARY', 'title': 'Urinary Distress Inventory (UDI) Obstructive Symptom Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Midurethral Sling', 'description': 'Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.'}, {'id': 'OG001', 'title': 'Sham Incision', 'description': 'Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.'}], 'classes': [{'title': '3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-27.3', 'spread': '22.69', 'groupId': 'OG000'}, {'value': '-28.0', 'spread': '20.81', 'groupId': 'OG001'}]}]}, {'title': '12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-26.4', 'spread': '22.69', 'groupId': 'OG000'}, {'value': '-27.1', 'spread': '21.39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months, and 12 months post-surgery', 'description': 'Scores on the UDI subscales range from 0 to 100, with higher score indicating more symptoms. Results measure the average change in scores from baseline to follow-up.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Women who completed the UDI obstructive symptom subscale survey at baseline and 3 and 12 months after the index surgery.'}, {'type': 'SECONDARY', 'title': 'Urinary Distress Inventory (UDI) Irritative Symptom Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Midurethral Sling', 'description': 'Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.'}, {'id': 'OG001', 'title': 'Sham Incision', 'description': 'Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.'}], 'classes': [{'title': '3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-12.5', 'spread': '18.83', 'groupId': 'OG000'}, {'value': '-10.5', 'spread': '17.06', 'groupId': 'OG001'}]}]}, {'title': '12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.9', 'spread': '17.15', 'groupId': 'OG000'}, {'value': '-11.6', 'spread': '15.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months, and 12 months post-surgery', 'description': 'Scores on the UDI subscales range from 0 to 100, with higher score indicating more symptoms. Results measure the average change in scores from baseline to follow-up.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Women who completed the UDI irritative symptom subscale survey at baseline and 3 months after the index surgery.'}, {'type': 'SECONDARY', 'title': 'Urinary Distress Inventory (UDI) Stress Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Midurethral Sling', 'description': 'Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.'}, {'id': 'OG001', 'title': 'Sham Incision', 'description': 'Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.'}], 'classes': [{'title': '3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.1', 'spread': '16.29', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '20.42', 'groupId': 'OG001'}]}]}, {'title': '12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.7', 'spread': '14.62', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '16.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months, and 12 months post-surgery', 'description': 'Scores on the UDI subscales range from 0 to 100, with higher score indicating more symptoms. Results measure the average change in scores from baseline to follow-up.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Women who completed the UDI stress subscale survey at baseline and 3 and 12 months after the index surgery.'}, {'type': 'SECONDARY', 'title': 'Incontinence Severity Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Midurethral Sling', 'description': 'Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.'}, {'id': 'OG001', 'title': 'Sham Incision', 'description': 'Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.'}], 'classes': [{'title': '3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '3.01', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '3.26', 'groupId': 'OG001'}]}]}, {'title': '12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months, and 12 months post-surgery', 'description': 'Scores on the Incontinence Severity Index range from 1 to 12, with higher scores indicating greater severity. Results measure average change in scores from baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Women who completed the Incontinence Severity Index survey at baseline and 3 and 12 months after the index surgery.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Midurethral Sling', 'description': 'Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.'}, {'id': 'FG001', 'title': 'Sham Incision', 'description': 'Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '165'}, {'groupId': 'FG001', 'numSubjects': '172'}]}, {'type': '3 Months', 'achievements': [{'groupId': 'FG000', 'numSubjects': '163'}, {'groupId': 'FG001', 'numSubjects': '171'}]}, {'type': '12 Months', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}, {'groupId': 'FG001', 'numSubjects': '165'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}, {'groupId': 'FG001', 'numSubjects': '165'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'All women presenting to the participating PFDN clinical centers with the complaint of prolapse, as defined by the inclusion criteria, will be screened for the subjective complaint of SUI using items on the PFDI. Eligible individuals will be offered RCT participation.', 'preAssignmentDetails': 'Participants consisted of women who were being considered for an apical and/or anterior vaginal prolapse repair via a vaginal approach without subjective complaints of SUI. They must have had vaginal bulge symptoms (defined as positive responses to the PFDI), and anterior vaginal prolapse with point Aa at -1cm or greater (determined by POP-Q).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Midurethral Sling', 'description': 'Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.'}, {'id': 'BG001', 'title': 'Sham Incision', 'description': 'Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '63.4', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '62.2', 'spread': '10.2', 'groupId': 'BG001'}, {'value': '62.8', 'spread': '10.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '286', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '289', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Annual Income <$30,000', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Self-reported question, population is those who provided a response.'}, {'title': 'Married', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '324', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Self-reported question, population is those who provided a response.'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27.8', 'spread': '4.9', 'groupId': 'BG000'}, {'value': '28.1', 'spread': '5.5', 'groupId': 'BG001'}, {'value': '28.0', 'spread': '5.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pelvic Organ Prolapse Quantification', 'classes': [{'title': '2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}, {'title': '3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}]}, {'title': '4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '(1=lowest point of prolapse is \\>1cm above the hymen; 2=within 1 cm above or below the hymen; 3= \\>1cm below the hymen but protrudes no more than 2cm less than the total vaginal length; 4=complete vaginal eversion)', 'unitOfMeasure': 'Participants'}, {'title': 'Positive Cough Stress Test', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'A leakage of urine with coughing or straining in either the supine or standing position with the bladder filled through a urethral catheter to 300ml.', 'unitOfMeasure': 'Participants'}, {'title': 'Anterior Vaginal - Prolapse Repair', 'classes': [{'title': 'Anterior Repair Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': 'Apical Suspension Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}, {'title': 'Both Anterior Repair and Apical Suspension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}]}, {'title': 'Colpocleisis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Posterior Vaginal - Prolapse Repair', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous Hysterectomy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Concomitant Hysterectomy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 337}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-30', 'studyFirstSubmitDate': '2007-04-13', 'resultsFirstSubmitDate': '2017-04-18', 'studyFirstSubmitQcDate': '2007-04-13', 'lastUpdatePostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-08', 'studyFirstPostDateStruct': {'date': '2007-04-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment Failure Defined as Subsequent Treatment for Urinary Incontinence, Signs or Symptoms of Bothersome Urinary Incontinence', 'timeFrame': '3 months post-surgery', 'description': 'Defined as a positive cough stress test, bothersome incontinence symptoms, or treatment for urinary incontinence, and urinary incontinence (stress, urge, or mixed), regardless of whether interim treatment for incontinence had been provided.'}, {'measure': 'Prevalence of Bothersome Urinary Incontinence at 12 Months Following Index Surgery', 'timeFrame': '12 months post-surgery', 'description': 'Defined as a positive cough stress test or report of bothersome incontinence symptoms.'}], 'secondaryOutcomes': [{'measure': 'Medical Outcomes Study 36-Item Short Form Health Survey', 'timeFrame': 'Baseline, 3 months, and 12 Months post-surgery', 'description': 'This survey is a generic health-related quality of life measure. Scores have normalized values with a mean of 50 and a standard deviation of 10, with higher scores indicating better health status. Results measure the average change in scores from baseline to follow-up.'}, {'measure': 'Positive Cough Stress Test', 'timeFrame': '3 and 12 Months Post-surgery', 'description': 'A leakage of urine with coughing or straining in either the supine or standing position with the bladder filled through a urethral catheter to 300 ml.'}, {'measure': 'Symptoms of Incontinence', 'timeFrame': '3 and 12 Months Post-surgery', 'description': 'Symptoms that were at least moderately bothersome to the participant (as measured by a response of "moderately" or "quite a bit" to any of the four items on the Pelvic Floor Distress Inventory regarding leakage).'}, {'measure': 'Treatment for Incontinence', 'timeFrame': '3 months post-surgery', 'description': 'The need for treatment for any urinary incontinence, including surgery, medication, pessary for incontinence, supervised pelvic-muscle exercises, timed voiding and fluid management, periurethral injection, botulinum toxin injection, neuromodulation, or other treatment for incontinence.'}, {'measure': 'Pelvic Floor Distress Inventory (PFDI) Urinary Distress Inventory (UDI)', 'timeFrame': 'Baseline, 3 months, and 12 months post-surgery', 'description': 'PFDI is a symptom inventory for pelvic floor disorders. Scores ranges from 0 to 300, with higher scores indicating more symptoms. Results measure the average change in scores from baseline to follow-up.'}, {'measure': 'Urinary Distress Inventory (UDI) Obstructive Symptom Subscale', 'timeFrame': 'Baseline, 3 months, and 12 months post-surgery', 'description': 'Scores on the UDI subscales range from 0 to 100, with higher score indicating more symptoms. Results measure the average change in scores from baseline to follow-up.'}, {'measure': 'Urinary Distress Inventory (UDI) Irritative Symptom Subscale', 'timeFrame': 'Baseline, 3 months, and 12 months post-surgery', 'description': 'Scores on the UDI subscales range from 0 to 100, with higher score indicating more symptoms. Results measure the average change in scores from baseline to follow-up.'}, {'measure': 'Urinary Distress Inventory (UDI) Stress Subscale', 'timeFrame': 'Baseline, 3 months, and 12 months post-surgery', 'description': 'Scores on the UDI subscales range from 0 to 100, with higher score indicating more symptoms. Results measure the average change in scores from baseline to follow-up.'}, {'measure': 'Incontinence Severity Index', 'timeFrame': 'Baseline, 3 months, and 12 months post-surgery', 'description': 'Scores on the Incontinence Severity Index range from 1 to 12, with higher scores indicating greater severity. Results measure average change in scores from baseline.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prolapse', 'Urinary incontinence', 'TVT'], 'conditions': ['Pelvic Organ Prolapse']}, 'referencesModule': {'references': [{'pmid': '22716974', 'type': 'BACKGROUND', 'citation': 'Wei JT, Nygaard I, Richter HE, Nager CW, Barber MD, Kenton K, Amundsen CL, Schaffer J, Meikle SF, Spino C; Pelvic Floor Disorders Network. A midurethral sling to reduce incontinence after vaginal prolapse repair. N Engl J Med. 2012 Jun 21;366(25):2358-67. doi: 10.1056/NEJMoa1111967.'}, {'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.'}]}, 'descriptionModule': {'briefSummary': 'Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Prolapse may be corrected by surgery using either a vaginal or abdominal incision. Some women develop stress urinary incontinence (SUI) after surgery. A prior randomized trial has shown that use of a Burch sling at the time of an abdominal sacrocolpopexy decreases the risk of urinary incontinence; however, the benefit of adding an anti incontinence procedure to prevent SUI at the time of prolapse surgery performed via a vaginal approach is unclear. Thus, the objective of the Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) trial is to determine whether prophylactic treatment with Tension-free Vaginal Tape (TVT)® at the time of prolapse surgery done via a vaginal approach is effective in preventing urinary incontinence.', 'detailedDescription': 'The overall objective of this randomized clinical trial is to determine whether symptom-specific treatment of incontinence after prolapse surgery is equally effective to prophylactic treatment by adding TVT® at the time of the prolapse surgery among women with anterior vaginal prolapse but without pre-operative symptoms of stress urinary incontinence.\n\nThe primary aims are:\n\nIn stress continent women planning vaginal surgery for pelvic organ prolapse:\n\n1. To determine if the failure rate defined by subsequent treatment for urinary incontinence, signs or symptoms of bothersome urinary incontinence \\[defined as having at least moderate bother for any of 4 Pelvic Floor Distress Inventory (PFDI) incontinence items\\] differs between vaginal prolapse repair and vaginal prolapse repair plus TVT® during the first 3 months after the index surgery.\n2. To determine if the prevalence of bothersome urinary incontinence at 12 months after the index surgery differs between vaginal prolapse repair and vaginal prolapse repair plus TVT®, whether or not there was subsequent treatment for symptoms of urinary incontinence; i.e., to determine whether symptom-specific treatment of incontinence after prolapse surgery is equally effective to prophylactic treatment by adding a TVT® at the time of the prolapse surgery.\n3. To measure the total cost of care and relate the difference in cost of care between the two groups to differences in health utilities and health-related quality of life, which will allow us to examine the cost-effectiveness of prophylactic use of a TVT® at the time of prolapse surgery versus symptom-specific treatment of stress incontinence after prolapse surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nVaginal bulge symptoms as indicated by an affirmative response to either questions 4 or 5 of the PFDI:\n\n* Do you usually have a sensation of bulging or protrusion from the vaginal area?\n* Do you usually have a bulge or something falling out that you can see or feel in the vaginal area? Anterior vaginal prolapse defined by pelvic organ prolapse quantification (POP-Q) Point Aa ≥ -1 cm (i.e., -1,0,1,2, or 3 cm).\n\nSurgical plan that includes a vaginal approach for apical or anterior prolapse repair.\n\nAble and willing to complete data collection per protocol, including written informed consent.\n\nExclusion Criteria:\n\nPregnancy or planning pregnancy in the first postoperative year. Any prior mid urethral sling. Currently participating in another interventional study for urinary incontinence.\n\nUntreated urinary tract infection (may be included after resolution).\n\nOvert symptoms of stress urinary incontinence as defined by a positive response to any of the following 3 PFDI items:\n\n* Do you usually experience urine leakage related to coughing, sneezing, or laughing?\n* Do you usually experience urine leakage related to physical exercise such as walking, running, aerobics, or tennis?\n* Do you usually experience urine leakage related to lifting or bending over? Currently being treated for stress urinary incontinence with pessary/incontinence ring, pelvic floor muscle exercise or medication (duloxetine and imipramine, and alpha agonists).'}, 'identificationModule': {'nctId': 'NCT00460434', 'acronym': 'OPUS', 'briefTitle': 'Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling Trial', 'organization': {'class': 'NETWORK', 'fullName': 'NICHD Pelvic Floor Disorders Network'}, 'officialTitle': 'Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling (OPUS) Trial', 'orgStudyIdInfo': {'id': '15P01'}, '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': '1', 'description': 'Tension-free Vaginal Tape (TVT) surgery', 'interventionNames': ['Device: TVT']}, {'type': 'SHAM_COMPARATOR', 'label': '2', 'description': 'Sham Tension-free Vaginal Tape (TVT) surgery', 'interventionNames': ['Other: Sham']}], 'interventions': [{'name': 'TVT', 'type': 'DEVICE', 'description': 'Prophylactic TVT', 'armGroupLabels': ['1']}, {'name': 'Sham', 'type': 'OTHER', 'description': 'Sham TVT', 'armGroupLabels': ['2']}]}, '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': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'USCD 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': '35249', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT 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': 'John T Wei, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NICHD Pelvic Floor Disorders Network', 'class': 'NETWORK'}, 'collaborators': [{'name': "Office of Research on Women's Health (ORWH)", 'class': 'NIH'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}