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Transobturatory tape (TOT) procedure is a minimally invasive approach to urinary stress incontinence owing to the category of the sling-adopting procedures. Its efficacy and safety, also in comparison with similar procedures have been demonstrated. The benefits of the sling- adopting procedures in comparison to laparoscopic Burch colposuspension, which has been considered as the gold standard treatment, have been showed. But these comparisons did not included the TOT procedure in the experimental arms. Based on this considerations the aim of this trial will be to compare TOT and laparoscopic Burch colposuspension in women with urinary stress incontinence.
Women with predominant and genuine stress urinary incontinence will be enrolled and randomized in two groups (groups A and B). Patients of group A will be treated with laparoscopic Burch colposuspension, whereas patients of group B will be treated with TOT procedure.
All patients eligible will undergo baseline assessment consisting of anthropometric, clinical, hormonal, urodynamic, and ultrasonographic evaluations. During the study, the surgical outcomes, the clinical subjective and objective efficacy data, and the adverse experiences will be evaluated in each patient.
Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator |
| |
| Group B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic Burch colposuspension | Procedure | Lapaparoscopic approach. One or two nonadsorbable sutures are placed at the level of the midurethra without penetrating the vaginal mucosa and fixed to Cooper's ligament with a tension free knotting technique. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective/subjective symptoms improvements | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-operative complication rate | one day | |
| Postoperative complications rate | 12 months | |
| Failure rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefano Palomba, MD | Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro | Principal Investigator |
| Fulvio Zullo, MD | Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Pugliese" Hospital | Catanzaro | Catanzaro | 88100 | Italy |
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| Transobturator tape procedure | Procedure | Small incision sites in the vagina and in the femoral/pelvic fold. Bilateral transobturator insertion of mesh by means of needle. Application of resorbable tensioning suture that maintains the mesh and enables fine adjustments in mesh tension during the procedure and in the immediate postoperative period. |
|
| 12 months |
| Recurrence rate | 12 months |
| Quality of life | 12 months |
| Sexual function | 12 months |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| 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 |
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