Laparoscopic Burch Colposuspension Versus Modified Burch Colposuspension

Sponsor

Al-Azhar University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05616481

Collaborator

(none)

120

Enrollment

Location

Arms

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence Burch Colposuspention	Procedure: Laparoscopic Burch colposuspension Procedure: Modefied Burch (TOT - like)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Laparoscopic Burch Colposuspension Versus Modified Burch Colposuspension For Treatment Of Female Stress Urinary Incontinence; Randomized Controlled Trial

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Laparoscopic Burch The original procedure will be performed	Procedure: Laparoscopic Burch colposuspension The original Burch procedure will be performed
Active Comparator: Laparoscopic modefied Burch procedur (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.	Procedure: Modefied Burch (TOT - like) more lateral fixation to avoid post-operative voiding dysfunction

Arm

Intervention/Treatment

Active Comparator: Laparoscopic Burch

The original procedure will be performed

Procedure: Laparoscopic Burch colposuspension

The original Burch procedure will be performed

Active Comparator: Laparoscopic modefied Burch procedur (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.

Procedure: Modefied Burch (TOT - like)

more lateral fixation to avoid post-operative voiding dysfunction

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.