Ignite Creation Date:
2025-12-24 @ 1:13 PM
Ignite Modification Date:
2025-12-29 @ 4:32 AM
Study NCT ID:
NCT07276295
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Synthetic Versus Autologous Sling For Stress Incontinence (SASSI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053825', 'term': 'Suburethral Slings'}], 'ancestors': [{'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 232}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2032-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2032-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-11-26', 'studyFirstSubmitQcDate': '2025-12-09', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2032-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective urinary incontinence status measured by standing cough test', 'timeFrame': '5 years post-op', 'description': 'Unit of measure: proportion of participants Measurement tool: standing cough test positive, yes/no'}, {'measure': 'Incidence of new-onset chronic abdominopelvic pain since surgery by Likert pain intensity scale', 'timeFrame': '6 months post-op', 'description': 'Proportion of participants who report new abdominopelvic pain with an average intensity greater than 3 on a 0-10 Likert pain intensity scale over the past 6 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['autologous fascia sling', 'or tension-free vaginal tape', 'stress predominant urinary incontinence'], 'conditions': ['Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'This is a multi-centre randomized controlled trial comparing mid-urethral synthetic mesh sling or tension-free vaginal tape (TVT) and autologous fascia sling (AFS) in elderly patients with stress predominant urinary incontinence. The investigators aim to investigate new onset pelvic pain 6 months post-op and objective urinary incontinence cure rate 5 years post-op. Secondary objectives include investigation of opioid use, mental health, sexual health, and other post-op outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult females at birth (female anatomy, any gender)\n* Greater than or equal to 60 years old\n* Have stress predominant urinary incontinence (spUI) eligible for both types of surgery (tension-free vaginal tape and autologous fascia sling)\n* Exhausted conservative management options for UI (Kegel's exercises, physiotherapy, pessary)\n* Completed childbearing\n* Able to follow up with clinic visits for up to five years after surgery\n\nExclusion Criteria:\n\n* Clinical Frailty Score of 6 or more, as moderate frailty is likely associated with excessive postoperative deterioration\n* Concurrent pelvic surgery\n* Neurogenic bladder\n* Previous UI surgery\n* Previous pelvic radiation\n* Previous mesh exposure\n* Presence of pelvic pain for more than three months in the last five years\n* Likely unable to follow up\n* Immunocompromised individuals receiving immunosuppressive medications for at least 3 months\n* Chronic systemic steroid use for at least 3 months for autoimmune diseases\n* Unable to stop smoking for at least 3 months prior to surgery and at high risk of restart smoking post-operatively"}, 'identificationModule': {'nctId': 'NCT07276295', 'acronym': 'SASSI', 'briefTitle': 'Synthetic Versus Autologous Sling For Stress Incontinence (SASSI)', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Synthetic Versus Autologous Sling For Stress Incontinence (SASSI): A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'H25-02899'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'tension-free vaginal tape', 'interventionNames': ['Procedure: tension-free vaginal tape']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'autologous fascia sling', 'interventionNames': ['Procedure: autologous fascia sling']}], 'interventions': [{'name': 'autologous fascia sling', 'type': 'PROCEDURE', 'description': 'Participants will receive autologous fascia sling as surgery for stress predominant urinary incontinence.', 'armGroupLabels': ['autologous fascia sling']}, {'name': 'tension-free vaginal tape', 'type': 'PROCEDURE', 'description': 'Participants will receive tension-free vaginal tape as surgery for stress predominant urinary incontinence.', 'armGroupLabels': ['tension-free vaginal tape']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Roxana Geoffrion', 'investigatorAffiliation': 'University of British Columbia'}}}}