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In the treatment of urinary incontinence caused by coughing, sneezing, or heavy lifting, the investigators will perform urinary tract tightening surgery, both with and without a sling, to address the relaxed urinary tract. The investigators would like to evaluate the one-year success and results of the sling or non-sling urinary tract tightening surgery the investigators will perform on the participants.
The participants will undergo surgery to tighten the urinary tract due to urinary incontinence. There are two types of surgery: with and without a sling. Both have a high success rate. However, in rare cases, complications related to the sling method can occur in some patients. The urinary incontinence will be prevented with either the sling or non-sling method. The investigators will call the participants for follow-up appointments after the surgery to share the results with them.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stress urinary incontinence treated by transvaginal tape | Active Comparator | Patients with stress urinary incontinence will be randomised and at this arm, treated by transvaginal tape and evaluated at first year of the surgery. |
|
| Stress urinary incontinence treated with urethral ligament plication | Active Comparator | Patients with stress urinary incontinence will be randomised and at this arm, treated by urethral ligament plication and evaluated at first year of the surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transvaginal tape | Procedure | Method: The procedure uses a, usually polypropylene, mesh tape placed under the mid-urethra to reinforce the pelvic muscles. Approach: It involves a small vaginal incision and two small abdominal incisions to pull the tape through, which is then adjusted for proper tension. |
| Measure | Description | Time Frame |
|---|---|---|
| the outcome measures of transvaginal tape (TVT) and urethral ligament plication (ULP) surgeries: number of participants that have negatif cough test and subjective continence status. | the continence status at one-year of TVT and ULP surgeries by cough stress test and subjective complaint about stress urinary incontinence | at first postoperative year |
| Measure | Description | Time Frame |
|---|---|---|
| complications and adverse events | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0". During first postoperative year, the complications; like mesh erosion, suture reaction, bleeding, need for suture removal, need for mesh removal, urinary retention, bladder injury, bowel injury | during postoperative first year |
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Inclusion Criteria:
Exclusion Criteria:
Treatment of female stress urinary incontinence is studied.
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| Name | Affiliation | Role |
|---|---|---|
| Peter Emmanuel Petros, DSc DS PhD MB BS MD FRCOG | Unaffiliated, retired | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanlıurfa Training and Research Hospital | Sanliurfa | İnönü Mahallesi | 61000 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2093278 | Background | Petros PE, Ulmsten UI. An integral theory of female urinary incontinence. Experimental and clinical considerations. Acta Obstet Gynecol Scand Suppl. 1990;153:7-31. doi: 10.1111/j.1600-0412.1990.tb08027.x. | |
| 40864278 | Background | Esercan A, Sivaslioglu AA, Petros P. A Randomized Comparison of Transobturator Tape with the Plication of Urethral Ligaments in the Treatment of Stress Urinary Incontinence. Int Urogynecol J. 2025 Dec;36(12):2507-2515. doi: 10.1007/s00192-025-06193-z. Epub 2025 Aug 27. |
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The data will be shared by doi .
August 2026-September 2026
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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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|
| Urethral ligament plication | Procedure | By vaginal route, plication of the four attachments of pubourethral ligament (PUL) as retropubic part of PUL, midurethral part of PUL, external urethral ligament and pubococygeous muscle with 2-0 polyester suture. |
|
| 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 |