Comparison of Minisling Suburethral Sling and Laparoscopic Buch Colposuspension
- Conditions
- Genuine Stress Incontinence
- Interventions
- Procedure: laparoscopic burch colposuspension operationProcedure: minisling suburethral sling
- Registration Number
- NCT05225168
- Lead Sponsor
- Ataturk University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
- To be between the ages of 18-80
- Isolated genuine stress incontinence or accompanying pelvic organ prolapse
- Having accepted surgery for stress urinary incontinence -
-
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description laparoscopic burch colposuspension group laparoscopic burch colposuspension operation this group will only have laparoscopic burch colposuspension Minisling Suburethral Sling group minisling suburethral sling this group will only have Minisling Suburethral Sling
- Primary Outcome Measures
Name Time Method urinary stress test for evaluating objective cure changes in urodynamics test at postoperative first and the 6th month In the postoperative period, urodynamics test will be determined at the 6th month and the absence of incontinence will be considered a cure.
- Secondary Outcome Measures
Name Time Method Prolapse quality of life (P-QoL) scale changes at postoperative first and the 6th month 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.
subjective continence changes at postoperative first and the 6th month Patient satisfaction will be investigated by keeping a urinary diary and questioning the quality of life.
Female sexual function scale (FSFI) changes at postoperative first and the 6th month 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.
King's Health Questionnaire changes at postoperative first and the 6th month Patients will be evaluated with the King's Health Questionnaire
Trial Locations
- Locations (1)
Gamze Nur Cimilli Senocak
🇹🇷Erzurum, Turkey