Comparison of Minisling Suburethral Sling and Laparoscopic Buch Colposuspension

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Genuine Stress Incontinence

Intervention / Treatment
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* Procedure: laparoscopic burch colposuspension operation
* Procedure: minisling suburethral sling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: laparoscopic burch colposuspension group<br>this group will only have laparoscopic burch colposuspension | Procedure: laparoscopic burch colposuspension operation<br>* 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.<br>* Other names: minisling suburethral sling;|
| Active Comparator: Minisling Suburethral Sling group<br>this group will only have Minisling Suburethral Sling | Procedure: minisling suburethral sling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | changes in urodynamics test at postoperative first and the 6th month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjective continence | 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 | 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 | Patients will be evaluated with the King's Health Questionnaire | changes at postoperative first and the 6th month | 
| 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. | changes at postoperative first and the 6th month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Genuine Stress Incontinence, minisling, laparoscopic burch