Transobturator Sling Compared With Single-incision Mini-sling for the Treatment of Stress Urinary Incontinence

Study Overview
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Brief Summary
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OBJECTIVE: To determine the efficacy and safety of a single-incision mini-sling compared with a transobturator midurethral sling for stress urinary incontinence (SUI) treatment. METHODS: This prospective single-center randomized controlled trial will involve 100 women with a diagnosis of SUI. Primary outcomes were the objective and subjective cure rates, defined as negative cough stress and pad tests, and satisfaction rates. Quality of life assessed by the Incontinence Quality of Life Questionnaire and the Urogenital Distress Inventory Short Form, operation time, complications, and reoperation rates were also recorded. The efficacy was analyzed using a noninferiority test with a margin of 15%. For the noninferiority test, a P value >.05 rejects the noninferiority hypothesis of the mini-sling.

Official Title
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Transobturator Sling Compared With Single-incision Mini-sling for the Treatment of Stress Urinary Incontinence: A Randomized Controlled Trial

Conditions
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Injury Due to Sling-shot

Intervention / Treatment
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* Device: Ophira
* Device: Transobturator sling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged over 18 years Clinical and urodynamic diagnosis of stress urinary incontinence Absence of associated neurological diseases No clinically significant detrusor instability (ie, to determine which symptoms are proportionally more significant for patient incontinence efforts) Exclusion Criteria: urodynamic changes suggesting a reduction in bladder capacity, bladder compliance or suggestive of bladder outlet obstruction Coagulopathies Pregnancy History of sensitivity to foreign body Acute Urinary Tract Infection Sequelae of high exposure to ionizing radiation Use of drugs that can result in high and / or risk of significant postoperative complications surgical risk, including any drug that interferes with blood clotting anesthetic contraindication to the procedure Vulvovaginitis: presence of vaginal discharge with laboratory proven infection

Ages Eligible for Study
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Minimum Age: 18 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: Single incision mini-sling<br>Experimental group: surgery to treat stress urinary incontinence with the Ophira mini sling systemt® | Device: Ophira<br>* The procedure will be perfomed with a single incision in anterior wall vagina<br>|
| Active Comparator: Transobturator sling<br>Control group: surgery to treat stress urinary incontinence with the Unitape T Plus®. | Device: Transobturator sling<br>* Safyre T Plus ® system uses two helical needles for securing an average urethral sling mesh polypropylene soft tissue below the pubic bone by means of spinal anesthesia. Short form of the sling implantation is carried out as follows: a small longitudinal incision in the anterior vaginal wall approximately 2 cm is performed at 1 cm from the urethral meatus. Takes place below minimum dissection toward the lower branch of the ischium, and with the aid of the needle obturator and perforated membrane (outside-in maneuver). After that, the sling is attached to the needle carrying the same path. Subsequently, the passage of the needle is held in contraleral side. The procedure finishes performing the adjustment of the track with the aid of Kelly forceps type.<br>* Other names: Unitape T plus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the cure rates between the mini sling and classical transobturator tapes | Percentage of patients who are regarded as cured or improved based on the following criteria: Negative Cough Stress test 1 year after surgery Pad Test < 2 g 1 year after surgery | Up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events | Comparison of the intra- and postoperative complications between procedures | 0, 1, 6 and 12 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stress incontinence, transobturator sling, single-incision mini-sling