Genuine Stress Incontinence
Conditions
Keywords
Genuine Stress Incontinence, minisling, laparoscopic burch
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.
Interventions
PROCEDURElaparoscopic 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.
PROCEDUREminisling 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.
Sponsors
Ataturk University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| King's Health Questionnaire | changes at postoperative first and the 6th month | Patients will be evaluated with the King's Health Questionnaire |
| 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed