Comparison of Minisling Suburethral Sling and Laparoscopic Buch Colposuspension

April 20, 2023 updated by: Gamze Nur Cimilli Şenocak, Ataturk University

Comparison of Minisling Suburethral Sling Use and Laparoscopic Buch Colposuspension Application in Terms of Surgical Efficacy and Side Effects in True Stress Urinary Incontinence Surgery

When the studies in the literature including the mini-sling procedure and the laparoscopic buch colposuspension procedure are examined, it is seen that both methods are successful in the surgical treatment of stress urinary incontinence (SUI), but there is no study in which both procedures have been found to be superior to each other in terms of efficacy and safety. The aim of this study is to compare the minisling suburethral sling and laparoscopic buch colposuspension application in terms of efficacy and side effects in patients who will undergo surgical treatment due to genuine SUI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

When the studies in the literature including the mini-sling procedure and the laparoscopic buch colposuspension procedure are examined, it is seen that both methods are successful in the surgical treatment of stress urinery incontinence (SUI), but there is no study in which both procedures have been found to be superior to each other in terms of efficacy and safety. The aim of this study is to compare the minisling suburethral sling and laparoscopic buch colposuspension application in terms of efficacy and side effects in patients who will undergo surgical treatment due to genuine SUI. Investigators planned to measure patients' Kings Health Questionary and Prolapse Quality of Life test at first and 6 months after the surgery and to determine how the operation affects the quality of life.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Erzurum, Turkey, 25100
        • Gamze Nur Cimilli Senocak

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. To be between the ages of 18-80
  2. Isolated genuine stress incontinence or accompanying pelvic organ prolapse
  3. Having accepted surgery for stress urinary incontinence -

Exclusion Criteria:

  • 1. Previously undergo pelvic organ prolapse surgery 2. Having a chronic lung disease such as asthma or Chronic obstructive pulmonary disease (COPD) 3. Having juvenile diabetes mellitus 4. History of gynecological cancer 5. Mesh allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: laparoscopic burch colposuspension group
this group will only have laparoscopic burch colposuspension
Procedure: laparoscopic burch colposuspension operation
By pushing the urethra medially, two sutures are placed on the bladder at trigon level and midurethral and suspended on the bilateral iliopectineal ligament and colposuspension is supplied.
Other Names:
  • minisling suburethral sling
Active Comparator: Minisling Suburethral Sling group
this group will only have Minisling Suburethral Sling
Procedure: minisling suburethral sling
A vertical vaginal incision is made 1 cm below the external urethral meatus. It is followed by minimal vaginal dissection from the inferior portion of the ascending ramus of the ischiopubic bone to the obturator muscle. The arms of the mesh are fixed on both sides of the obturator internus muscle with the help of a trocar. After leaving a 1-2 mm gap between the mesh and the urethra, the vaginal wall is closed by suturing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
urinary stress test for evaluating objective cure
Time Frame: changes in urodynamics test at postoperative first and the 6th month
In the postoperative period, urodynamics test will be determined at the 6th month and the absence of incontinence will be considered a cure.
changes in urodynamics test at postoperative first and the 6th month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
subjective continence
Time Frame: changes at postoperative first and the 6th month
Patient satisfaction will be investigated by keeping a urinary diary and questioning the quality of life.
changes at postoperative first and the 6th month
Prolapse quality of life (P-QoL) scale
Time Frame: changes at postoperative first and the 6th month
Patients will be evaluated with the prolapse quality of life (P-QoL) scale. In this scale, the questions are rated 1 to 4, and as the total score increases, the quality of life decreases.
changes at postoperative first and the 6th month
King's Health Questionnaire
Time Frame: changes at postoperative first and the 6th month
Patients will be evaluated with the King's Health Questionnaire
changes at postoperative first and the 6th month
Female sexual function scale (FSFI)
Time Frame: changes at postoperative first and the 6th month
Patients will be evaluated with the Female sexual function scale (FSFI). In this scale, the questions are rated 0 to 5, and if the total score increases, it means the sexual life is better. A minimum of 2 and a maximum of 36 points can be obtained from this test.
changes at postoperative first and the 6th month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Investigators

  • Study Director: Yakup Kumtepe, Atatürk University
  • Principal Investigator: Yakup Kumtepe, Atatürk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2021

Primary Completion (Actual)

August 6, 2022

Study Completion (Actual)

March 23, 2023

Study Registration Dates

First Submitted

January 26, 2022

First Submitted That Met QC Criteria

January 26, 2022

First Posted (Actual)

February 4, 2022

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 20, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B.30.2.ATA.0.01.00/284

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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