Comparison of Minisling Suburethral Sling and Laparoscopic Buch Colposuspension

Sponsor
Ataturk University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05225168
Collaborator
(none)
80
1
2
24
3.3

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
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. King's Health Questionnaire [changes at postoperative the 6th month and 1st year]

      Patients will be evaluated with the King's Health Questionnaire

    4. 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:
    No
    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

    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 ┼×enocak, 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:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Gamze Nur Cimilli ┼×enocak, assistant professor, Ataturk University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 9, 2022