NCT05616481RecruitingNot Applicable
Laparoscopic Burch Colposuspension Versus Modified Burch Colposuspension For Treatment Of Female Stress Urinary Incontinence; Randomized Controlled Trial
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Al-Azhar University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- The success rates of both laparoscopic Burch colposuspension versus laparoscopic modified Burch colposuspension for treatment of female stress urinary incontinence
Study Overview
Brief Summary
This study aims to compare the success rate and complications following laparoscopic standard Burch colposuspension and laparoscopic modified Burch colposuspension (Transobturator tape like)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women with genuine stress urinary incontinence.
- •Mixed urinary incontinence with predominant stress element.
- •Refractory cases to conservative therapy or patients who are not willing to consider (further) conservative treatment.
Exclusion Criteria
- •Mixed incontinence with predominant Urge urinary incontinence.
- •Recent pelvic surgery (less than 3 months).
- •Neurogenic lower urinary tract dysfunction.
- •Previous surgery for stress urinary incontinence.
- •Pregnancy
- •Less than 12 months post-partum.
- •Other gynaecologic pathologies affecting bladder functions ( eg, fibroids, ovarian cysts)
- •Genito-urinary malignancy.
- •Current chemo or radiation therapy.
Arms & Interventions
Laparoscopic Burch
Active Comparator
The original procedure will be performed
Intervention: Laparoscopic Burch colposuspension (Procedure)
Laparoscopic modefied Burch procedur (TOT-like)
Active Comparator
Sutures on the pubocervical fascia are placed at the level of the attachment of the arcus tendinous fascia pelvis and the pubourethral ligament.
Intervention: Modefied Burch (TOT - like) (Procedure)
Outcomes
Primary Outcomes
The success rates of both laparoscopic Burch colposuspension versus laparoscopic modified Burch colposuspension for treatment of female stress urinary incontinence
Time Frame: 3 months post operative
Secondary Outcomes
- Complication rates of both techniques.(up to 3 months)
- Post operative rates of voiding dysfunction (at 3 months).(at 3 months)
- Overall operative time(Intraoperative (measured from verrus needle insertion))
Investigators
Mohamed Fawzy Abd Elfattah Salman
Director
Al-Azhar University
Study Sites (1)
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