Back to resultsLaparoscopic Burch Colposuspension Versus Modified Burch Colposuspension
Primary Purpose
Stress Urinary Incontinence, Burch Colposuspention
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Laparoscopic Burch colposuspension
Modefied Burch (TOT - like)
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Stress urinary incontinence, Burch Colposuspension, TOT
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.
Sites / Locations
- Mohamed Fawzy SalmanRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Laparoscopic Burch
Laparoscopic modefied Burch procedur (TOT-like)
Arm Description
The original procedure will be performed
Sutures on the pubocervical fascia are placed at the level of the attachment of the arcus tendinous fascia pelvis and the pubourethral ligament.
Outcomes
Primary Outcome Measures
The success rates of both laparoscopic Burch colposuspension versus laparoscopic modified Burch colposuspension for treatment of female stress urinary incontinence
Secondary Outcome Measures
Post operative rates of voiding dysfunction (at 3 months).
Overall operative time
Complication rates of both techniques.
Full Information
NCT ID
NCT05616481
First Posted
November 7, 2022
Last Updated
November 14, 2022
Sponsor
Al-Azhar University
1. Study Identification
Unique Protocol Identification Number
NCT05616481
Brief Title
Laparoscopic Burch Colposuspension Versus Modified Burch Colposuspension
Official Title
Laparoscopic Burch Colposuspension Versus Modified Burch Colposuspension For Treatment Of Female Stress Urinary Incontinence; Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence, Burch Colposuspention
Keywords
Stress urinary incontinence, Burch Colposuspension, TOT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic Burch
Arm Type
Active Comparator
Arm Description
The original procedure will be performed
Arm Title
Laparoscopic modefied Burch procedur (TOT-like)
Arm Type
Active Comparator
Arm Description
Sutures on the pubocervical fascia are placed at the level of the attachment of the arcus tendinous fascia pelvis and the pubourethral ligament.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Burch colposuspension
Intervention Description
The original Burch procedure will be performed
Intervention Type
Procedure
Intervention Name(s)
Modefied Burch (TOT - like)
Intervention Description
more lateral fixation to avoid post-operative voiding dysfunction
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Post operative rates of voiding dysfunction (at 3 months).
Time Frame
at 3 months
Title
Overall operative time
Time Frame
Intraoperative (measured from verrus needle insertion)
Title
Complication rates of both techniques.
Time Frame
up to 3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Fawzy Salman, MD
Phone
+201111788996
Email
prof_mohamed_fawzy@yahoo.com
Facility Information:
Facility Name
Mohamed Fawzy Salman
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Fawzy Salman, MD
Phone
+201111788996
Email
prof_mohamed_fawzy@yahoo.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
34475912
Citation
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.
Results Reference
result
PubMed Identifier
32339752
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.
Results Reference
result
PubMed Identifier
28723368
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.
Results Reference
result
PubMed Identifier
33017893
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.
Results Reference
result
PubMed Identifier
35181882
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.
Results Reference
result
Learn more about this trial
Laparoscopic Burch Colposuspension Versus Modified Burch Colposuspension
We'll reach out to this number within 24 hrs