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NCT Number: NCT05616481

Laparoscopic Burch Colposuspension Versus Modified Burch Colposuspension

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

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Key information

Conditions

Stress Urinary Incontinence Burch Colposuspention Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mohamed Fawzy Salman

Cairo, Cairo Governorate, Egypt

Location status: Recruiting

Location contact

Mohamed Fawzy Salman, MD

CONTACT

[email protected]

+201111788996

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laparoscopic Burch Colposuspension

Procedure

The original Burch procedure will be performed

Modefied Burch (TOT - like)

Procedure

more lateral fixation to avoid post-operative voiding dysfunction

Primary outcomes

  1. 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

  1. Post operative rates of voiding dysfunction (at 3 months).

    Time frame: at 3 months

  2. Overall operative time

    Time frame: Intraoperative (measured from verrus needle insertion)

  3. Complication rates of both techniques.

    Time frame: up to 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Fawzy Salman, MD

CONTACT

[email protected]

+201111788996

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 15, 2022
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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