Comparison of Minisling Suburethral Sling and Laparoscopic Buch Colposuspension

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

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-06

Study Completion Date

2023-03-23

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.

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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.

Conditions

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Genuine Stress Incontinence

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 colposuspension group

this group will only have laparoscopic burch colposuspension

Group Type ACTIVE_COMPARATOR

laparoscopic burch colposuspension operation

Intervention Type PROCEDURE

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.

Minisling Suburethral Sling group

this group will only have Minisling Suburethral Sling

Group Type ACTIVE_COMPARATOR

minisling suburethral sling

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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minisling suburethral sling

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No