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To test efficacy and safety at six months of the proposed Pubourethral Plication Procedure (PPP) for cure of stress urinary incontinence - reinforcing pubourethral ligaments (PUL) with large diameter polyester sutures.
Full thickness vaginal incisions will be made in the suburethral sulci extending from bladder neck to urethral meatus. The operation space is 2.5cm2 space. A No2 or 3 polyester suture will be inserted into PUL, immediately lateral to midurethra, into PUL origin, external urethral ligament, laterally into m.pubococcygeus, then will be tied, but not tightly. The vaginal incisions will be closed with vicryl sutures. All women will be discharged on day of surgery. During the regular follow ups the healing at stress urinary incontinence will be evaluated
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polyester suture arm | Experimental | A No 3 polyester suture will be inserted into the external urethral ligament, into the uurethral part of pubourethral ligament and into the pubic part of the pubourethral lgament then will be tied, but not tightly. The interventions will be carried on either side of the urethra that will be opened up by an 2.5 cm incision in the periurethral sulci. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyester suture | Other | A No2 polyester suture will be used for tying special anatomical structures fr telieving the symptom. of stress urinary incontinence |
|
| Measure | Description | Time Frame |
|---|---|---|
| Curing effect of the suturation | The plication of pubourethral ligaments with a polyester suture will lead to a neoligament formation; so that the pubourethral ligaments will get strenghened. If the pubourethral ligaments get strengthened woman will not loose urine upon stressful activities such as coughing. Hence the stress test will be negative. And the rate of negative stress test within the cohort will show us the efficinecy of operation in curing urinary incontinence | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AHMET AKIN SIVASLIOGLU, Prof. | Contact | +905322770618 | akinsivaslioglu@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| AHMET AKIN SIVASLIOGLU, Prof | Mugla SITKI KOÇMAN UNİVERSITY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Muğla Training and Research Hospital | Recruiting | Muğla | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D059952 | Pelvic Floor Disorders |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 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 |
| D011248 | Pregnancy Complications |