Autologous Versus Synthetic Versus Biological Sling for Trans-obturator Correction of Urinary Stress Incontinence

Study Overview
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Brief Summary
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The treatment of urinary stress incontinence with trans-obturator approach, know as transobturatory tape (TOT), is a largely used sling-adopting procedures. The efficacy and safety of this minimally invasive surgery have been demonstrated, also in comparison with similar procedures, i.e transvaginal tape (TVT). To date the results of TOT in terms of efficacy and safety described in literature mainly refer to procedure in which synthetic materials are used, whereas few data regarding the use of biological materials are available. Moreover, despite the well known benefits of the available synthetic and eterologue kit, their use may be limited by the high cost of these materials. At this proposal it can be suggested as alternative option the possibility to perform the procedure using an autologous tissue, i.e. rectus fascia, and reusable introductory needles. Based on these considerations the aim of this trial will be to compare autologous, synthetic and biological mesh for TOT in women with urinary stress incontinence.

Detailed Description
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Women with genuine stress urinary incontinence will be enrolled and randomized in three groups (arm 1, arm 2, arm 3). All patients will be treated with a transobturatory approach, in patients of arm 1 will be used an autologous tissue and reusable introductory needles, in patients of arm 2 will be used a synthetic kit whereas in arm 3 will be a biological kit . All eligible patients 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.

Official Title
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A Comparison in Terms of Efficacy and Safety Among Three Different Materials for Trans-obturator Correction of Urinary Stress Incontinence: Autologous, Synthetic and Biological Sling

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Procedure: Autologous transobturator tape procedure
* Procedure: Synthetic transobturator tape procedure
* Procedure: Biological transobturator tape procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Genuine stress urinary incontinence by self report, examination and test Urethral hypermobility Eligible for all three surgical procedures Ambulatory Exclusion Criteria: Pregnancy <12 months post-partum Systemic disease and/or drugs known to affect bladder function Current chemotherapy or radiation therapy Urethral diverticulum, augmentation cytoplasty, or artificial sphincter Recent pelvic surgery Severe genuine stress incontinence (loss of urine with minimal physical activity) with associated prolapse equal to or more than second degree Previous pelvic or anti-incontinence surgery History of severe abdominopelvic infections Known extensive abdominopelvic adhesions Detrusor instability and/or intrinsic sphincter dysfunction Other gynaecologic pathologies (eg, fibroids, ovarian cysts) BMI >30

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Autologous sling | Procedure: Autologous transobturator tape procedure<br>* A strip of rectus fascia is harvested. Small incision sites in the vagina and in the femoral/pelvic fold. Bilateral transobturator insertion of the autologous strip by means of reusable needles<br>|
| Active Comparator: 2<br>Synthetic sling | Procedure: Synthetic transobturator tape procedure<br>* Small incision sites in the vagina and in the femoral/pelvic fold. Bilateral transobturator insertion of synthetic mesh by means of mono-use needles.<br>|
| Active Comparator: 3<br>Biological sling | Procedure: Biological transobturator tape procedure<br>* Small incision sites in the vagina and in the femoral/pelvic fold. Bilateral transobturator insertion of biological mesh by means of mono-use needle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-operative complication rate |  | one day | 
| Postoperative complications rate |  | 12 months | 
| Failure rate |  | 12 months | 
| Recurrence rate |  | 12 months | 
| Quality of life |  | 12 months | 
| Sexual function |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autologous, Biological, Mesh, Polypropylene, Sling, Synthetic, Stress incontinence, Surgery, TOT, Treatment