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Comparison of Minisling Suburethral Sling and Laparoscopic Buch Colposuspension

Primary Purpose

Genuine Stress Incontinence

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
laparoscopic burch colposuspension operation
minisling suburethral sling
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genuine Stress Incontinence focused on measuring Genuine Stress Incontinence, minisling, laparoscopic burch

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Gamze Nur Cimilli Senocak

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

laparoscopic burch colposuspension group

Minisling Suburethral Sling group

Arm Description

this group will only have laparoscopic burch colposuspension

this group will only have Minisling Suburethral Sling

Outcomes

Primary Outcome Measures

urinary stress test for evaluating objective cure
In the postoperative period, urodynamics test will be determined at the 6th month and the absence of incontinence will be considered a cure.

Secondary Outcome Measures

subjective continence
Patient satisfaction will be investigated by keeping a urinary diary and questioning the quality of life.
Prolapse quality of life (P-QoL) scale
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.
King's Health Questionnaire
Patients will be evaluated with the King's Health Questionnaire
Female sexual function scale (FSFI)
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.

Full Information

First Posted
January 26, 2022
Last Updated
April 20, 2023
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT05225168
Brief Title
Comparison of Minisling Suburethral Sling and Laparoscopic Buch Colposuspension
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 6, 2021 (Actual)
Primary Completion Date
August 6, 2022 (Actual)
Study Completion Date
March 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genuine Stress Incontinence
Keywords
Genuine Stress Incontinence, minisling, laparoscopic burch

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
laparoscopic burch colposuspension group
Arm Type
Active Comparator
Arm Description
this group will only have laparoscopic burch colposuspension
Arm Title
Minisling Suburethral Sling group
Arm Type
Active Comparator
Arm Description
this group will only have Minisling Suburethral Sling
Intervention Type
Procedure
Intervention Name(s)
laparoscopic burch colposuspension operation
Other Intervention Name(s)
minisling suburethral sling
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
minisling suburethral sling
Intervention Description
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.
Primary Outcome Measure Information:
Title
urinary stress test for evaluating objective cure
Description
In the postoperative period, urodynamics test will be determined at the 6th month and the absence of incontinence will be considered a cure.
Time Frame
changes in urodynamics test at postoperative first and the 6th month
Secondary Outcome Measure Information:
Title
subjective continence
Description
Patient satisfaction will be investigated by keeping a urinary diary and questioning the quality of life.
Time Frame
changes at postoperative first and the 6th month
Title
Prolapse quality of life (P-QoL) scale
Description
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.
Time Frame
changes at postoperative first and the 6th month
Title
King's Health Questionnaire
Description
Patients will be evaluated with the King's Health Questionnaire
Time Frame
changes at postoperative first and the 6th month
Title
Female sexual function scale (FSFI)
Description
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.
Time Frame
changes at postoperative first and the 6th month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: To be between the ages of 18-80 Isolated genuine stress incontinence or accompanying pelvic organ prolapse 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yakup Kumtepe
Organizational Affiliation
Ataturk University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yakup Kumtepe
Organizational Affiliation
Ataturk University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gamze Nur Cimilli Senocak
City
Erzurum
ZIP/Postal Code
25100
Country
Turkey

12. IPD Sharing Statement

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Comparison of Minisling Suburethral Sling and Laparoscopic Buch Colposuspension

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