Comparison of Minisling Suburethral Sling and Laparoscopic Buch Colposuspension

Genuine Stress Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05225168
• Other study ID #: B.30.2.ATA.0.01.00/284
• Status: Completed
• Phase: N/A
• Start date: July 6, 2021
• Est. completion date: March 23, 2023

Study information

• Verified date: April 2023
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 23, 2023
• Est. primary completion date: August 6, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Genuine Stress Incontinence
• Urinary Incontinence, Stress

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Gamze Nur Cimilli Senocak	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	King's Health Questionnaire	Patients will be evaluated with the King's Health Questionnaire	changes at postoperative first and the 6th month
Secondary	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