Laparoscopic Burch Colposuspension Versus Modified Burch Colposuspension

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

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

Study Overview

• Status: Recruiting
• Conditions: Stress Urinary Incontinence; Burch Colposuspention
• Intervention / Treatment: Procedure: Laparoscopic Burch colposuspension; Procedure: Modefied Burch (TOT - like)

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Fawzy Salman, MD; Phone Number: +201111788996; Email: prof_mohamed_fawzy@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Mohamed Fawzy Salman
    • Contact: Mohamed Fawzy Salman, MD; Phone Number: +201111788996; Email: prof_mohamed_fawzy@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Al-Azhar University

Publications and helpful links

General Publications

• Kim A, Kim S, Kim HG. Current Overview of Surgical Options for Female Stress Urinary Incontinence. Int Neurourol J. 2020 Sep;24(3):222-230. doi: 10.5213/inj.2040052.026. Epub 2020 Sep 30.
• Abrar S, Razzak L, Mohsin R. The practice of Burch Colposuspension versus Mid Urethral Slings for the treatment of Stress Urinary Incontinence in developing country. Pak J Med Sci. 2021 Sep-Oct;37(5):1359-1364. doi: 10.12669/pjms.37.5.4017.
• Aleksandrov A, Meshulam M, Rabischong B, Botchorishvili R. Laparoscopic TOT-like Burch Colposuspension: Back to the Future? J Minim Invasive Gynecol. 2021 Jan;28(1):24-25. doi: 10.1016/j.jmig.2020.04.018. Epub 2020 Apr 24.
• Carmel ME, Deng DY, Greenwell TJ, Zimmern PE. Definition of Success after Surgery for Female Stress Incontinence or Voiding Dysfunction: An Attempt at Standardization. Eur Urol Focus. 2016 Aug;2(3):231-237. doi: 10.1016/j.euf.2016.03.005. Epub 2016 Mar 26.
• Marquini GV, Bella ZIKJD, Sartori MGF. Burch Procedure: A Historical Perspective. Rev Bras Ginecol Obstet. 2022 May;44(5):511-518. doi: 10.1055/s-0042-1744312. Epub 2022 Feb 18.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 14, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 23, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Stress urinary incontinence; TOT; Burch Colposuspension
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: Burch versus Modefied Burch

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No