Laparoscopic Burch Colposuspension Versus Modified Burch Colposuspension

NCT ID: NCT05616481

Last Updated: 2025-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2025-07-31

Brief Summary

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

Detailed Description

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Conditions

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Stress Urinary Incontinence Burch Colposuspention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laparoscopic Burch

The original procedure will be performed

Group Type ACTIVE_COMPARATOR

Laparoscopic Burch colposuspension

Intervention Type PROCEDURE

The original Burch procedure will be performed

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.

Group Type ACTIVE_COMPARATOR

Modefied Burch (TOT - like)

Intervention Type PROCEDURE

more lateral fixation to avoid post-operative voiding dysfunction

Interventions

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Laparoscopic Burch colposuspension

The original Burch procedure will be performed

Intervention Type PROCEDURE

Modefied Burch (TOT - like)

more lateral fixation to avoid post-operative voiding dysfunction

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Fawzy Abd Elfattah Salman

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mohamed Fawzy Salman

Cairo, Cairo Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed Fawzy Salman, MD

Role: CONTACT

+201111788996

Facility Contacts

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Mohamed Fawzy Salman, MD

Role: primary

+201111788996

References

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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.

Reference Type BACKGROUND
PMID: 34475912 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32339752 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28723368 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33017893 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35181882 (View on PubMed)

Other Identifiers

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Burch versus Modefied Burch

Identifier Type: -

Identifier Source: org_study_id

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