Viewing Study NCT02348112

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Ignite Creation Date: 2025-12-26 @ 10:46 PM
Ignite Modification Date: 2026-03-02 @ 3:27 AM
Study NCT ID: NCT02348112
Status: COMPLETED
Last Update Posted: 2023-12-04
First Post: 2015-01-16
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'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'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'usedri@coloplast.com', 'phone': '1-800-258-3476', 'title': 'Liz Driessen', 'organization': 'Coloplast Corp.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The strengths of the Altis 522 Study include its large sample size, prospective, multicenter design and use of a wide variety of standardized and validated instruments to collect patient reported outcomes over a 36-month study duration. Potential limitations associated with the study include rates of enrollment, subject attrition rates, and differences in baseline characteristics.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected through 36 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Altis Arm', 'description': 'Subjects will have an Altis sling placed to treat stress urinary incontinence.', 'otherNumAtRisk': 184, 'deathsNumAtRisk': 184, 'otherNumAffected': 74, 'seriousNumAtRisk': 184, 'deathsNumAffected': 0, 'seriousNumAffected': 24}, {'id': 'EG001', 'title': 'Comparator Arm', 'description': 'Subjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence.', 'otherNumAtRisk': 171, 'deathsNumAtRisk': 171, 'otherNumAffected': 66, 'seriousNumAtRisk': 171, 'deathsNumAffected': 1, 'seriousNumAffected': 29}], 'otherEvents': [{'term': 'Urinary retention/obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hip pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pelvic / urogenital pain (groin)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspareunia, de novo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leg pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hip and leg pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Recurrent incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspareunia, worsening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urgency, worsening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 61, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 96, 'numAffected': 39}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urgency, de novo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Bleeding, hematoma or hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Delayed wound healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mesh exposure (extrusion)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shortness of breath, chest pain, L jaw/neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pelvic / urogenital pain (groin)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Perforation, bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary retention/obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Abscess following appendectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Adenomyosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Broke left arm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Broke right arm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Broken left ankle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Broken right ankle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cervical Spinal Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diverticular stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elective surgery of total prosthesis right knee', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Exacerbation of COPD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intra-abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left Carotid Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left Humerus Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metastatic cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Morbid Obesity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non STEMI myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Parastomal abscess and cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paroxysmal Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Partial small bowel obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Patient hurt her shoulder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Perianal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pre-Cancerous Cells Removed From Left Breast', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rectal Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Retro-sternal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right Elbow fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right Shoulder Reconstructive Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right bimalleolar ankle fracture, fibular fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right carpal tunnel release surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Small bowel obstruction and fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thoracic Degenerative Discs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Total right knee prothesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening Right knee pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal cardiac stress test', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal mammogram', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bilateral knee pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Drug overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Endometrial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased blood sugars', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Medial meniscus tear of right knee', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ocular migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary thromboembolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Recurrent gluteus Medius tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right coronary occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right index finger and thumb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Small bowel obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Spinal cord stimulator', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Total left knee prothesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Unstable angina / chest pains', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Effectiveness Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Altis Arm', 'description': 'Subjects will have an Altis sling placed to treat stress urinary incontinence.'}, {'id': 'OG001', 'title': 'Comparator Arm', 'description': 'Subjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence.'}], 'classes': [{'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.013', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.054', 'ciLowerLimit': '-0.139', 'ciUpperLimit': '0.031', 'statisticalMethod': 'Normal approximation test (Z-test)', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The number and proportion of subjects experiencing a 50% or greater reduction in pad weight at 6 months were compared, and non-inferiority assessed using a normal approximation test (Z-test) for a difference in binomial proportion. Non-inferiority was considered achieved if the 95% confidence interval for the difference in proportions (Comparator - Altis) was less than 0.15.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Observed effectiveness, defined as a reduction from baseline in 24 hour pad weight of at least 50% at 6 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled subjects (Intent-to-Treat (ITT) analysis population) who have undergone a sling implant attempt for stress urinary incontinence using either Altis SIS or an FDA cleared transobturator or retropubic sling (modified Intent-to-Treat (mITT) analysis population). The mITT analysis population is a subset of the ITT population. The mITT analysis population is the primary analysis population for the assessment of all safety and effectiveness endpoints.'}, {'type': 'PRIMARY', 'title': 'Primary Safety Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Altis Arm', 'description': 'Subjects will have an Altis sling placed to treat stress urinary incontinence.'}, {'id': 'OG001', 'title': 'Comparator Arm', 'description': 'Subjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.013', 'ciLowerLimit': '-0.023', 'ciUpperLimit': '0.048', 'statisticalMethod': 'Normal approximation test (Z-test)', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The number and proportion of subjects experiencing device- and/or procedure-related serious adverse events were tabulated for each study group. Non-inferiority through 36 months was calculated using a normal approximation test (Z-test) for a difference in binomial proportion. Non-inferiority was considered achieved if the lower limit of the 95% confidence interval for the difference in proportions (Comparator - Altis) is greater than -0.10 in the mITT analysis population.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 months', 'description': 'Observed device and/or procedure-related serious adverse events through 36 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled subjects (Intent-to-Treat (ITT) analysis population) who have undergone a sling implant attempt for stress urinary incontinence using either Altis SIS or an FDA cleared transobturator or retropubic sling (modified Intent-to-Treat (mITT) analysis population). The mITT analysis population is a subset of the ITT population. The mITT analysis population is the primary analysis population for the assessment of all safety and effectiveness endpoints.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Altis Arm', 'description': 'Subjects will have an Altis sling placed to treat stress urinary incontinence.'}, {'id': 'FG001', 'title': 'Comparator Arm', 'description': 'Subjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '213'}, {'groupId': 'FG001', 'numSubjects': '203'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '140'}, {'groupId': 'FG001', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '102'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Site closed due to PI leaving', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'Sponsor withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Altis Arm', 'description': 'Subjects will have an Altis sling placed to treat stress urinary incontinence.'}, {'id': 'BG001', 'title': 'Comparator Arm', 'description': 'Subjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '413', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '308', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '2 participants in the Altis arm and 1 participant in the Comparator arm with age unknown.'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '413', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '56.4', 'spread': '11.8', 'groupId': 'BG000'}, {'value': '53.6', 'spread': '12.0', 'groupId': 'BG001'}, {'value': '55.1', 'spread': '12.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '2 participants in the Altis arm and 1 participant in the Comparator arm with age unknown.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '213', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '156', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '333', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '205', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '372', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pad Weight (g)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '88.0', 'spread': '155.8', 'groupId': 'BG000'}, {'value': '96.8', 'spread': '154.7', 'groupId': 'BG001'}, {'value': '92.3', 'spread': '155.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'grams', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '14 participants in the Altis arm and 16 participants in the Comparator arm with pad weight test not done.'}], 'populationDescription': 'Intent-to-Treat (ITT) analysis population is all enrolled subjects. A subject is considered enrolled once signed informed consent is obtained.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-01', 'size': 1162147, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-11-30T14:05', 'hasProtocol': True}, {'date': '2021-08-08', 'size': 402244, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-11-30T14:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 416}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2021-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-29', 'studyFirstSubmitDate': '2015-01-16', 'resultsFirstSubmitDate': '2023-02-20', 'studyFirstSubmitQcDate': '2015-01-22', 'lastUpdatePostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-20', 'studyFirstPostDateStruct': {'date': '2015-01-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Effectiveness Endpoint', 'timeFrame': '6 months', 'description': 'Observed effectiveness, defined as a reduction from baseline in 24 hour pad weight of at least 50% at 6 months.'}, {'measure': 'Primary Safety Endpoint', 'timeFrame': '36 months', 'description': 'Observed device and/or procedure-related serious adverse events through 36 months.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stress urinary incontinence', 'Altis 522', 'urinary incontinence'], 'conditions': ['Stress Urinary Incontinence']}, 'referencesModule': {'references': [{'pmid': '39423154', 'type': 'DERIVED', 'citation': 'Erickson T, Gheiler E, Hanson CE, McCrery R, Parekh M, Parva M, Tu LM. Patient Satisfaction and QoL in SUI: Results With Single-Incision or Full-Length Slings. Urogynecology (Phila). 2025 Oct 1;31(10):942-951. doi: 10.1097/SPV.0000000000001586.'}, {'pmid': '32320798', 'type': 'DERIVED', 'citation': 'Erickson T, Roovers JP, Gheiler E, Parekh M, Parva M, Hanson C, McCrery R, Tu LM. A Multicenter Prospective Study Evaluating Efficacy and Safety of a Single-incision Sling Procedure for Stress Urinary Incontinence. J Minim Invasive Gynecol. 2021 Jan;28(1):93-99. doi: 10.1016/j.jmig.2020.04.014. Epub 2020 Apr 19.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this postmarket study is to compare the safety and effectiveness of the Altis Single Incision Sling (SIS) to an FDA cleared transobturator and/or retropubic sling through 36 months.', 'detailedDescription': 'This study is a prospective, post-market, multi-center, cohort assessment comparing Altis SIS (n=178) and transobturator and/or retropubic slings (n=178) in the treatment of stress urinary incontinence at up to 40 U.S. and international sites. Subjects will be followed for a total of 36 months with scheduled visits at 6, 12, 18, 24 and 36 months. The study population will consist of adult female subjects with stress urinary incontinence who are clinically indicated for surgical intervention with a mesh sling.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be selected from urology or urogynecology specialties.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The subject is female and at least 18 years of age.\n* The subject is able and willing to complete all procedures and follow-up visits indicated in this protocol.\n* The subject has confirmed stress urinary incontinence (SUI) through cough stress test or urodynamics.\n* The subject has failed two non-invasive incontinence therapies (such as Kegel exercise, behavior modification, pad use, biofeedback, etc.) for \\> 6 months.\n\nExclusion Criteria:\n\n* The subject has an active urogenital infection or active skin infection in region of surgery.\n* The subject has confirmed Pelvic Organ Prolapse (POP) of Stage 2 or higher as determined by POP-Q prolapse grading.\n* The subject is having a concomitant pelvic floor procedure.\n* The subject has incontinence due to neurogenic causes (e.g. multiple sclerosis, spinal cord/brain injury, cerebrovascular accident, detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions).\n* The subject had a prior surgical stress urinary incontinence (SUI) treatment.\n* The subject has undergone radiation or brachy therapy to treat pelvic cancer.\n* The subject has urge predominant incontinence by MESA assessment.\n* The subject has an atonic bladder or post void residual (PVR) above 100 cc on ≥ 2 occasions.\n* The subject is pregnant and/or is planning to get pregnant in the future.\n* The subject has a contraindication to the surgical procedure or the product Instructions for Use (IFU).\n* The subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function, without the sponsors approval."}, 'identificationModule': {'nctId': 'NCT02348112', 'briefTitle': 'Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coloplast A/S'}, 'officialTitle': 'A Post-Market Evaluation of the Altis® Single Incision Sling System Versus Transobturator or Retropubic Mesh Sling in the Treatment of Female Stress Urinary Incontinence', 'orgStudyIdInfo': {'id': 'SU020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Altis arm', 'description': 'Subjects will have an Altis sling placed to treat stress urinary incontinence.', 'interventionNames': ['Device: Altis Single Incision Sling']}, {'label': 'Comparator arm', 'description': 'Subjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence.', 'interventionNames': ['Device: Transobturator or Retropubic Sling']}], 'interventions': [{'name': 'Altis Single Incision Sling', 'type': 'DEVICE', 'description': 'Altis is a minimally invasive, adjustable incontinence sling that is placed through a single incision in the vaginal wall and anchored inside the body. The sling has an integrated tensioning system eliminating the need for additional skin exits.', 'armGroupLabels': ['Altis arm']}, {'name': 'Transobturator or Retropubic Sling', 'type': 'DEVICE', 'description': 'Both transobturator and retropubic slings are a hammock-like mesh placed underneath the urethra to provide support. A single incision is made in the vaginal wall and two incisions in the abdomen. Tensioning of the sling is achieved by pulling the sling through the abdominal incisions.', 'armGroupLabels': ['Comparator arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Pelvic Solutions Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Urology Specialists, LLC', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Rosemark Women Care Specialists', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '46825', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': "Women's Health 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