Laparoscopic Burch Colposuspension Versus Modified Burch Colposuspension

Al-Azhar University

Status: Enrolling

Conditions: Burch Colposuspention; Stress Urinary Incontinence

Treatments: Procedure: Modefied Burch (TOT - like); Procedure: Laparoscopic Burch colposuspension

Study type: Interventional

Funder types: Other

Identifiers

NCT05616481

Burch versus Modefied Burch

Details and patient eligibility

About

This study aims to compare the success rate and complications following laparoscopic standard Burch colposuspension and laparoscopic modified Burch colposuspension (Transobturator tape like)

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Laparoscopic Burch

Active Comparator group

Description:

The original procedure will be performed

Treatment:

Procedure: Laparoscopic Burch colposuspension

Laparoscopic modefied Burch procedur (TOT-like)

Active Comparator group

Description:

Sutures on the pubocervical fascia are placed at the level of the attachment of the arcus tendinous fascia pelvis and the pubourethral ligament.

Treatment:

Procedure: Modefied Burch (TOT - like)