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NCT05616481 Clinical Trial

Laparoscopic Burch Colposuspension Versus Modified Burch Colposuspension

Stress Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05616481
Other study ID # Burch versus Modefied Burch
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date October 2024

Study information
Verified date November 2022
Source Al-Azhar University
Contact Mohamed Fawzy Salman, MD
Phone +201111788996
Email prof_mohamed_fawzy@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date October 2024
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Laparoscopic Burch colposuspension
The original Burch procedure will be performed
• Modefied Burch (TOT - like)
more lateral fixation to avoid post-operative voiding dysfunction

Locations
Country Name City State
Egypt Mohamed Fawzy Salman Cairo

Sponsors (1)
Lead Sponsor Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Post operative rates of voiding dysfunction (at 3 months). at 3 months
Secondary Overall operative time Intraoperative (measured from verrus needle insertion)
Secondary Complication rates of both techniques. up to 3 months
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