NCT02775526CompletedNot Applicable
Trans-Obturator Tape, Tension-Free Vaginal Tape and Burch Colposuspension for Treatment of Female Mixed Urinary Incontinence: A Randomized Clinical Trial
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- objective cure rate
Study Overview
Brief Summary
This prospective interventional randomized controlled trial will recruit women with MUI scheduled for surgical treatment where patients will be randomized to either Burch colposuspension, TOT or TVT. Regular postoperative follow up will be planned for at least 2 years. The primary outcome measures will be the objective and subjective cure rates.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women with mixed urinary incontinence.
Exclusion Criteria
- •Women with associated gynecological surgery e.g. uterine prolapse, previous anti-incontinence surgery, intrinsic sphincter deficiency (ISD), and medical disorders affecting the bladder innervation as diabetes mellitus were excluded from the study.
- •Women who improved on medical treatment with persistence of stress element only were also excluded.
Arms & Interventions
TOT
Active Comparator
TOT
Intervention: TOT (Procedure)
TVT
Active Comparator
TVT
Intervention: TVT (Procedure)
Burch colposuspension
Active Comparator
Burch colposuspension
Intervention: Burch Colposuspension (Procedure)
Outcomes
Primary Outcomes
objective cure rate
Time Frame: 2 years
subjective cure rate
Time Frame: 2 years
Secondary Outcomes
No secondary outcomes reported
Investigators
Mohamed S Sweed, MD
Dr
Ain Shams University
Study Sites (1)
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