Clinical trial NCT05225168: Comparison of Minisling Suburethral Sling and Laparoscopic Buch Colposuspension
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genuine Stress Incontinence
Keywords: Genuine Stress Incontinence
minisling
laparoscopic burch
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 at first and 6 months after the surgery and to determine how the operation affects the quality of life.

Eligibility criteria: 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

Primary outcomes:
measure: urinary stress test for evaluating objective cure
timeFrame: changes in urodynamics test at postoperative first and the 6th month
Secondary outcomes:
measure: subjective continence
timeFrame: changes at postoperative first and the 6th month
measure: Prolapse quality of life (P-QoL) scale
timeFrame: changes at postoperative first and the 6th month
measure: King's Health Questionnaire
timeFrame: changes at postoperative first and the 6th month
measure: Female sexual function scale (FSFI)
timeFrame: changes at postoperative first and the 6th month
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Gamze Nur Cimilli Senocak
Study officials:
affiliation: Ataturk University
name: Yakup Kumtepe
role: STUDY_DIRECTOR
affiliation: Ataturk University
name: Yakup Kumtepe
role: PRINCIPAL_INVESTIGATOR
References: