Comparison of Minisling Suburethral Sling and Laparoscopic Buch Colposuspension

NCT05225168 | Completed

• 1 other identifier: B.30.2.ATA.0.01.00/284
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Genuine Stress Incontinence

Keywords

Genuine Stress Incontinence; minisling; laparoscopic burch

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• subjective continence

  changes at postoperative first and the 6th month

• Prolapse quality of life (P-QoL) scale

  changes at postoperative first and the 6th month

• King's Health Questionnaire

  changes at postoperative first and the 6th month

• Female sexual function scale (FSFI)

  changes at postoperative first and the 6th month

Study Arms (2)

laparoscopic burch colposuspension group

ACTIVE COMPARATOR

this group will only have laparoscopic burch colposuspension

Procedure: laparoscopic burch colposuspension operation

Minisling Suburethral Sling group

ACTIVE COMPARATOR

this group will only have Minisling Suburethral Sling

Procedure: minisling suburethral sling

Interventions

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.

Also known as: minisling suburethral sling

laparoscopic burch colposuspension group

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.

Minisling Suburethral Sling group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Gamze Nur Cimilli Senocak

Erzurum, 25100, Turkey (Türkiye)

Location

Related Publications (1)

• Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.

  PMID: 37888839 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

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

Study Officials

• Yakup Kumtepe

  Ataturk University

  STUDY DIRECTOR

• Yakup Kumtepe

  Ataturk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 4, 2022
• Study Start: July 6, 2021
• Primary Completion: August 6, 2022
• Study Completion: March 23, 2023
• Last Updated: April 24, 2023

Record last verified: 2023-04

Locations

TU (1)