Anterior Defect Correction With Mesh Plus Treatment of Stress Incontinence With Transobturator or Transvaginal Approach

Study Overview
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Brief Summary
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The incidence of anterior pelvic defect in women is estimated about 10% and it may be often associated to urinary stress incontinence. To date the correction of anterior defects with the use of graft material inserted with transobturator approach has become of large use. Moreover, given the frequent association of urinary stress incontinence to anterior defect, in most of cases it becomes necessary to perform at the same time an anti-incontinence procedure, i.e. a sub-urethral sling positioning. Based on these considerations the aim of this trial will be to compare two different approach for sub-urethral sling positioning, transobturator and transvaginal tape (TOT and TVT) performed in association to transobturator correction of anterior defect with mesh in terms of efficacy and safety.

Detailed Description
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Women with anterior defect and genuine stress urinary incontinence will be enrolled and randomized in two groups (arm 1 and 2). All patients will be treated with a transobturator correction of anterior defect, in patients of arm 1 will be associated TOT, whereas in patients of arm 2 will be associated TVT. 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.

Official Title
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A Comparison in Terms of Efficacy and Safety Between Transobturator and Transvaginal Tape Performed at the Same Time of Anterior Defect Correction With Mesh

Conditions
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Cystocele, Stress Urinary Incontinence

Intervention / Treatment
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* Procedure: Transobturatory correction of anterior defect plus TOT
* Procedure: Transobturatory correction of anterior defect plus TVT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cystocele Genuine stress urinary incontinence by self report, examination and test Urethral hypermobility Eligible for both 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 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 |
| --- | --- |
| Experimental: 1<br>Transobturatory correction of anterior defect plus TOT | Procedure: Transobturatory correction of anterior defect plus TOT<br>* Longitudinal vaginal incision 1 cm far from esternal urethral meatus. Bladder dissecting and identification of ischiatic spines. Bilateral transobturator insertion of anterior mesh through high and low trans-obturatory approach. Mesh anchorage. Small incision sites in the femoral/pelvic fold. Bilateral transobturator insertion of mesh by means of mono-use needle<br>|
| Active Comparator: 2<br>Longitudinal vaginal incision 1 cm far from esternal urethral meatus. Bladder dissecting and identification of ischiatic spines. Bilateral transobturator insertion of anterior mesh through high and low trans-obturatory approach. Mesh anchorage. Small incision sites at sovrapubic level. Bilateral retropubic insertion of mesh by means of mono-use needle. | Procedure: Transobturatory correction of anterior defect plus TVT<br>* Longitudinal vaginal incision 1 cm far from esternal urethral meatus. Bladder dissecting and identification of ischiatic spines. Bilateral transobturator insertion of anterior mesh through high and low trans-obturatory approach. Mesh anchorage. Small incision sites at sovrapubic level. Bilateral retropubic insertion of 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 |
| --- | --- | --- |
| Objective/subjective symptoms improvements |  | 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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Cystocele, Mesh, Prolapse, Sling, Stress incontinence, Surgery, TOT, TVT, Treatment