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NCT Number: NCT05225168

Comparison of Minisling Suburethral Sling and Laparoscopic Buch Colposuspension

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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Key information

Conditions

Genuine Stress Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gamze Nur Cimilli Senocak

Erzurum, 25100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laparoscopic burch colposuspension operation

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.

Other names: minisling suburethral sling

minisling suburethral sling

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. King's Health Questionnaire

    Time frame: changes at postoperative first and the 6th month

    Patients will be evaluated with the King's Health Questionnaire

  4. 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.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Feb 4, 2022
Registry last updated
Apr 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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