NCT05616481

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 15, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

3.4 years

First QC Date

November 7, 2022

Last Update Submit

May 23, 2025

Conditions

Stress Urinary IncontinenceBurch Colposuspention

Keywords

Stress urinary incontinenceBurch ColposuspensionTOT

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

Laparoscopic Burch

ACTIVE COMPARATOR

The original procedure will be performed

Procedure: Laparoscopic Burch colposuspension

Laparoscopic modefied Burch procedur (TOT-like)

ACTIVE COMPARATOR

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)

Interventions

Laparoscopic Burch colposuspensionPROCEDURE

The original Burch procedure will be performed

Laparoscopic Burch
Modefied Burch (TOT - like)PROCEDURE

more lateral fixation to avoid post-operative voiding dysfunction

Laparoscopic modefied Burch procedur (TOT-like)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed Fawzy Salman

Cairo, Cairo Governorate, Egypt

RECRUITING

Related 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.

    PMID: 34475912BACKGROUND

  • 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: 32339752BACKGROUND

  • 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: 28723368BACKGROUND

  • 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: 33017893BACKGROUND

  • 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: 35181882BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Mohamed Fawzy Salman, MD

CONTACT

+201111788996prof_mohamed_fawzy@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 7, 2022

First Posted

November 15, 2022

Study Start

January 1, 2022

Primary Completion

June 1, 2025

Study Completion

July 1, 2025

Last Updated

May 29, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)