Laparoscopic Burch Colposuspension Versus Modified Burch Colposuspension

Not Applicable

Recruiting

• Conditions: Stress Urinary Incontinence; Burch Colposuspention
• Interventions: Procedure: Modefied Burch (TOT - like); Procedure: Laparoscopic Burch colposuspension

• Registration Number: NCT05616481
• Lead Sponsor: Al-Azhar University

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-11-07
• Study First Submitted QC: 2022-11-14
• Study First Posted: 2022-11-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15
• Primary Completion: 2024-10
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic modefied Burch procedur (TOT-like)	Modefied Burch (TOT - like)	Sutures on the pubocervical fascia are placed at the level of the attachment of the arcus tendinous fascia pelvis and the pubourethral ligament.
Laparoscopic Burch	Laparoscopic Burch colposuspension	The original procedure will be performed

Primary Outcome Measures

Name	Time	Method
The success rates of both laparoscopic Burch colposuspension versus laparoscopic modified Burch colposuspension for treatment of female stress urinary incontinence	3 months post operative

Secondary Outcome Measures

Name	Time	Method
Post operative rates of voiding dysfunction (at 3 months).	at 3 months
Complication rates of both techniques.	up to 3 months
Overall operative time	Intraoperative (measured from verrus needle insertion)

Trial Locations

Locations (1)

Mohamed Fawzy Salman; 🇪🇬 Cairo, Egypt