Comparison of Minisling Suburethral Sling and Laparoscopic Buch Colposuspension

Sponsor

Ataturk University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05225168

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Genuine Stress Incontinence	Procedure: laparoscopic burch colposuspension operation Procedure: minisling suburethral sling	N/A

Detailed 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 6 and 12 months after the surgery and to determine how the operation affects the quality of life.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 6, 2021

Actual Primary Completion Date :

Mar 6, 2022

Anticipated Study Completion Date :

Mar 6, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: laparoscopic burch colposuspension group this group will only have laparoscopic burch colposuspension	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. Other Names: minisling suburethral sling
Active Comparator: Minisling Suburethral Sling group this group will only have Minisling Suburethral Sling	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.

Arm

Intervention/Treatment

Active Comparator: laparoscopic burch colposuspension group

this group will only have laparoscopic burch colposuspension

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.

Other Names:

minisling suburethral sling

Active Comparator: Minisling Suburethral Sling group

this group will only have Minisling Suburethral Sling

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.

Outcome Measures

Primary Outcome Measures

urodynamics test for evaluating objective cure [changes in urodynamics test at postoperative the 6th month and 1st year]
In the postoperative period, urodynamics test will be determined at the 6th month and 1st year, and the absence of incontinence will be considered a cure.

Secondary Outcome Measures

subjective continence [changes at postoperative the 6th month and 1st year]
Patient satisfaction will be investigated by keeping a urinary diary and questioning the quality of life.
Prolapse quality of life (P-QoL) scale [changes at postoperative the 6th month and 1st year]
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.
King's Health Questionnaire [changes at postoperative the 6th month and 1st year]
Patients will be evaluated with the King's Health Questionnaire
Female sexual function scale (FSFI) [changes at postoperative the 6th month and 1st year]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gamze Nur Cimilli Senocak	Erzurum		Turkey	25100

Sponsors and Collaborators

Ataturk University

Investigators

Study Director: Yakup Kumtepe, Ataturk University
Principal Investigator: Yakup Kumtepe, Ataturk University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gamze Nur Cimilli Şenocak, assistant professor, Ataturk University

ClinicalTrials.gov Identifier:

NCT05225168

Other Study ID Numbers:

B.30.2.ATA.0.01.00/284

First Posted:

Feb 4, 2022

Last Update Posted:

Mar 9, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gamze Nur Cimilli Şenocak, assistant professor, Ataturk University

Genuine Stress Incontinence

minisling

laparoscopic burch

Additional relevant MeSH terms:

Urinary Incontinence, Stress

Study Results

No Results Posted as of Mar 9, 2022