A Randomized Controlled Study Comparing Three Single-incision Devices for Female Urinary Stress Incontinence

Study Overview
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Brief Summary
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The prevalence of urinary stress incontinence in middle age women is rated at about 30%. To date, there is an increasing use in the clinical practice of new techniques for the treatment of this condition and several surgical devices, characterized by minimally invasive approach, are commercialized. Recently, single-incision devices have been proposed. One of the most relevant potential advantages of these devices is the possibility of performing their positioning under local anesthesia, thus, in ambulatory regimen. The employment of these devices is particularly useful in two subgroups of patients with urinary incontinence, i.e. women with genuine stress incontinence not associated to pelvic organ prolapse (POP) and women whose stress incontinence raised after surgical correction of (severe) POP. Poor data coming from randomized controlled trials (RCTs) are available regarding single-incision devices for the treatment of stress incontinence, and there are no conclusions in terms of their feasibility, efficacy and safety. Finally, to our knowledge no randomized controlled trial is actually available in literature comparing different single-incision devices.

Detailed Description
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Women with genuine urinary stress incontinence not associated with POP will be enrolled and randomized in three groups (arm 1, arm 2 and arm 3). All patients eligible will undergo baseline assessment consisting of anthropometric, clinical, hormonal, ultrasonographic and urodynamic evaluations. At time of surgery, all patients will be randomized in three surgical treatment groups (arm 1, 2 and 3). Patients of arm 1 will be treated with positioning of Ajust (Bard Urological Division, Covington, GA, USA), patients of group 2 will be treated with positioning of MiniArc (AMS, Minnetonka, MN, USA) and patients of arm 3 will be treated with positioning of TVT Secur System (Ethicon, Somerville, NJ, USA). During the study, the clinical outcomes, and the adverse experience 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 Among Three Single-incision Devices for the Treatment of Female Urinary Genuine Stress Incontinence: a Randomized Controlled Study.

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Procedure: MiniArc positioning
* Procedure: TVT secur system positioning
* Procedure: Ajust positioning
* Procedure: Tension free vaginal ttape


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: genuine stress incontinence Exclusion Criteria: pregnancy <12 months postpartum systemic disease and/or drugs known to affect bladder function current chemotherapy or radiation therapy urethral diverticulum augmentation cytoplasty artificial sphincter genital prolapse equal to or more than second degree history of severe abdominopelvic infections detrusor instability and/or intrinsic sphincter dysfunction other gynecologic pathologies 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>Patients treated with Ajust positioning | Procedure: Ajust positioning<br>* Patient placed in lithotomic position. 1.5 cm incision made, starting 1 cm down to the urethral meatus. Tunneling wide to 12-15 mm up to the bonny edge horizontally to the inferior pubic arm by spreading the scissors blades while withdrawing it, at a plane parallel to the vaginal wall. Mucosal undermining performed at the level of the upper and lower frenulum attaching the sub-urethral tissue to the vaginal wall. Insertion of the device to the bonny edge, horizontaly to the inferior pubic arm, and behind the bone edge to the internal obturator muscle. Ajust will be placed by means of a safe hook geometry introducer. Incision closure.<br>|
| Active Comparator: 2<br>Patients treated with MiniArc positioning | Procedure: MiniArc positioning<br>* Patient placed in lithotomic position. 1.5 cm incision made, starting 1 cm down to the urethral meatus. Tunneling wide to 12-15 mm up to the bonny edge horizontally to the inferior pubic arm by spreading the scissors blades while withdrawing it, at a plane parallel to the vaginal wall. Mucosal undermining performed at the level of the upper and lower frenulum attaching the sub-urethral tissue to the vaginal wall. Insertion of the device to the bonny edge, horizontaly to the inferior pubic arm, and behind the bone edge to the internal obturator muscle. MiniArc will be placed by means of curved single use needle. Incision closure.<br>|
| Active Comparator: 3<br>Patients treated with TVT secur system | Procedure: TVT secur system positioning<br>* Patient placed in lithotomic position. 1.5 cm incision made, starting 1 cm down to the urethral meatus. Tunneling wide to 12-15 mm up to the bonny edge horizontally to the inferior pubic arm by spreading the scissors blades while withdrawing it, at a plane parallel to the vaginal wall. Mucosal undermining performed at the level of the upper and lower frenulum attaching the sub-urethral tissue to the vaginal wall. Insertion of the device to the bonny edge, horizontaly to the inferior pubic arm, and behind the bone edge to the internal obturator muscle. TVT Secur System will be placed by means of two curved, stainless steel, single use introducers. Incision closure.<br>|
| Active Comparator: 4<br>Patients treated with tension free vaginal tape | Procedure: Tension free vaginal ttape<br>* Patient placed in lithotomic position. 15 mm vaginal incision below urethral meatus. Dissection of the paraurethral space on each side of the incision and of the bladder from the inferior edge of the pubis. Transversal 10 mm skin incisions at level of superior pubic margin. Top-down or bottom-up approach passage of the needles and sling. Adjustment of sling tension. Closure of vaginal and skin incisions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective cure rate (compared to results of TVT) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective cure rate |  |  | 
| Intraoperative complication rate |  | one day | 
| Blood loss |  |  | 
| Postoperative complication rate |  | thirty days | 
| Long-term complication rate |  | twelve months | 
| Postoperative pain |  |  | 
| Patients' satisfaction |  |  | 
| Sexual function |  |  | 
| Quality of life |  |  | 
| Recurrence rate |  |  | 
| Feasibility (degree of surgical difficulty in non-trained surgeons) |  |  | 
| Learning curve (change in operative time, intra- and post-operative complications over the time |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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single-incision, sling, stress incontinence, surgery, treatment, Female urinary stress incontinence