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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laparoscopic burch colposuspension group | Active Comparator | this group will only have laparoscopic burch colposuspension |
|
| Minisling Suburethral Sling group | Active Comparator | this group will only have Minisling Suburethral Sling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic burch colposuspension operation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| urinary stress test for evaluating objective cure | In the postoperative period, urodynamics test will be determined at the 6th month and the absence of incontinence will be considered a cure. | changes in urodynamics test at postoperative first and the 6th month |
| Measure | Description | Time Frame |
|---|---|---|
| subjective continence | Patient satisfaction will be investigated by keeping a urinary diary and questioning the quality of life. | changes at postoperative first and the 6th month |
| Prolapse quality of life (P-QoL) scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yakup Kumtepe | Ataturk University | Study Director |
| Yakup Kumtepe | Ataturk University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gamze Nur Cimilli Senocak | Erzurum | 25100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37888839 | Derived | Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4. |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| minisling suburethral sling | Procedure | 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. |
|
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.
| changes at postoperative first and the 6th month |
| King's Health Questionnaire | Patients will be evaluated with the King's Health Questionnaire | changes at postoperative first and the 6th month |
| Female sexual function scale (FSFI) | 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. | changes at postoperative first and the 6th month |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |