Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT04133935
Status:
WITHDRAWN
Last Update Posted:
2021-11-22
First Post:
2019-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treating Stress Urinary Incontinence: Laparoscopic Obturator Urethropexy vs Burch Urethropexy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}], 'ancestors': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Upon recruitment to the study, the surgeon will then open a sequentially numbered, opaque, sealed envelope that will randomize the patient to either receiving Burch colposuspension or LOU. The patient will not be made aware of the group they were allocated to.\n\nA clinical staff who was not involved with the surgery and blinded to the allocation of the patient will complete the Post-operative Follow-up Form at each visit.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double-blinded, randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Due to COVID restrictions this study has been temporarily halted.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2033-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-13', 'studyFirstSubmitDate': '2019-09-30', 'studyFirstSubmitQcDate': '2019-10-17', 'lastUpdatePostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Continence Rates', 'timeFrame': '1 year', 'description': 'Patient reported symptoms of incontinence'}], 'secondaryOutcomes': [{'measure': 'Objective continence rates', 'timeFrame': '6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years', 'description': 'Objective continence rates will be assessed with a cough test and a one-hour pad test.'}, {'measure': 'Perioperative and postoperative complications', 'timeFrame': '6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years', 'description': 'Perioperative and postoperative complications will be assessed using the Clavien-Dindo (CD) classification.'}, {'measure': 'Urinary retention', 'timeFrame': '6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years', 'description': 'Urinary retention will be assessed by an elevated post-void residual urine'}, {'measure': 'Recurrent urinary tract infection', 'timeFrame': '6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years', 'description': 'Recurrent urinary tract infection will be assessed through a urine culture'}, {'measure': 'Recurrent/persistent/de novo urgency', 'timeFrame': '6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years', 'description': 'Recurrent/persistent/de novo urgency will be based on patient symptoms'}, {'measure': 'Recurrent SUI', 'timeFrame': '6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years', 'description': 'Recurrent SUI will be assessed through a cough test/a one-hour pad test'}, {'measure': 'Sexual function', 'timeFrame': '6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years', 'description': 'Using the Female Sexual Function Index-6 (FSFI-6).'}, {'measure': 'Overall quality of life', 'timeFrame': '6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years', 'description': 'Using the Pelvic Floor Distress Inventory-20 (PFDI-20).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress Urinary Incontinence']}, 'descriptionModule': {'briefSummary': "Stress urinary incontinence (SUI) is a highly prevalent concern within the female population. Although mid urethral slings (MUS) have been the first line treatment for SUI for almost twenty years, due to recent FDA warnings and many countries banning the use of vaginal mesh, a significant portion of patients now request non-mesh anti-incontinence procedures. In such cases, Burch colposuspension would be the next option discussed with patients.\n\nIn the short term, the efficacy of Burch colposuspension is comparable to MUS. However, the noteworthy disadvantages of Burch colposuspension include a high rate of urinary retention. This increased risk of urinary retention is due to the acute angle of the stitches, and is a problem that Burch colposuspension shares with the retropubic sling, a type of acutely-angled MUS. A variant of the retropubic sling, the transobturator tape (TOT), has shown that a rounder angle of elevation significantly reduces the risk of urinary retention. As such, this study proposes a novel technique of laparoscopic obturator urethropexy (LOU) as an alternative to the traditional Burch colposuspension.\n\nIn this new proposed technique, stitches are placed into the obturator internus fascia rather than Cooper's ligament, reducing the angle of elevation of the bladder neck, aiming to lower the risk of post-operative urinary retention. The aim of our randomized control trial is to assess the effectiveness of LOU compared to Burch colposuspension in terms of urinary continence. Our secondary aim is to report on perioperative and postoperative complications, functional outcomes including urinary retention, recurrent urinary tract infection, recurrent/persistent urgency, de novo urgency, recurrent SUI, and sexual function, as well as overall quality of life."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age and be able to read and write English\n* Women with symptomatic SUI, stress predominant mixed urinary incontinence symptoms confirmed on urodynamic study (UDS), or occult SUI (i.e. demonstrable urinary leakage on preoperative urodynamics with prolapse reduction in a patient without overt urinary incontinence symptoms), including women undergoing concomitant pelvic organ prolapse (POP) surgery or MUS sling removal\n\nExclusion Criteria:\n\n* Known or suspected disease that affects bladder function (e.g. multiple sclerosis, Parkinson disease), including a known diagnosis of voiding dysfunction\n* Pregnancy\n* Desired fertility\n* Urethral diverticulum\n* History of radical pelvic surgery or pelvic radiation therapy\n* Current chemotherapy or radiation therapy for malignancy'}, 'identificationModule': {'nctId': 'NCT04133935', 'briefTitle': 'Treating Stress Urinary Incontinence: Laparoscopic Obturator Urethropexy vs Burch Urethropexy', 'organization': {'class': 'OTHER', 'fullName': 'Mount Sinai Hospital, Canada'}, 'officialTitle': 'Prospective Review of Laparoscopic Burch Urethropexy Compared With a Novel Technique of Laparoscopic Obturator Urethropexy: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '19-0210-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laparoscopic Obturator Urethropexy', 'description': 'Suspending the periurethral vaginal tissue to the obturator internus fascia bilaterally via sutures, creating a support for the bladder neck compartment', 'interventionNames': ['Procedure: Laparoscopic Obturator Urethropexy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Burch Urethropexy', 'description': "Suspending the periurethral vaginal tissue to Cooper's ligament bilaterally via sutures, creating a support for the bladder neck compartment", 'interventionNames': ['Procedure: Burch Urethropexy']}], 'interventions': [{'name': 'Laparoscopic Obturator Urethropexy', 'type': 'PROCEDURE', 'description': 'Suspending the periurethral vaginal tissue to the obturator internus fascia bilaterally via sutures, creating a support for the bladder neck compartment.', 'armGroupLabels': ['Laparoscopic Obturator Urethropexy']}, {'name': 'Burch Urethropexy', 'type': 'PROCEDURE', 'description': "Suspending the periurethral vaginal tissue to Cooper's ligament bilaterally via sutures, creating a support for the bladder neck compartment", 'armGroupLabels': ['Burch Urethropexy']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mount Sinai Hospital, Canada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Nucelio Luiz de Barros Moreira Lemos MD, PhD', 'investigatorAffiliation': 'Mount Sinai Hospital, Canada'}}}}