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Recruiting NCT05616481

Laparoscopic Burch Colposuspension Versus Modified Burch Colposuspension

No phase Interventional Stress Urinary Incontinence Burch Colposuspention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Laparoscopic Burch colposuspension, Modefied Burch (TOT - like).
Who it may be relevant to
Registry conditions: Stress Urinary Incontinence, Burch Colposuspention. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

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

Primary outcome measures

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Mohamed Fawzy Salman — Cairo

Publications

  • 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. PMID 34475912
  • 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. PMID 32339752
  • 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. PMID 28723368
  • 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. PMID 33017893
  • 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. PMID 35181882

Identifiers

NCT: NCT05616481 · Burch versus Modefied Burch

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗