Midurethral Synthetic Tape With Tension Control Mechanism Versus Midurethral Free Tape

Study Overview
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Brief Summary
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This is a prospective, comparative randomized controled trial. The general purposes of this study is to compare the efficacy and safety of midurethral synthetic tape with tension control mechanism and conventional midurethral tension free tape as surgical treatment for female urinary stress incontinence.

Official Title
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Evaluation of the Effectiveness and Safety of the Midurethral Synthetic Tape With Tension Control Mechanism and Midurethral Tension Free Tape

Conditions
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Urinary Stress Incontinence

Intervention / Treatment
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* Procedure: surgical management of stress urinary incontinence with midurethral tension free tape.
* Procedure: surgical management of stress urinary incontinence with synthetic tape with tension control mechanism.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women suffering from stress urinary incontinence, mixed urinary incontinence with prevalence stress urinary incontinence Exclusion Criteria: Pregnancy Women with neurogenic bladder dysfunction Recurrent stress urinary incontinence Woman with history of pelvic surgery Mixed urinary incontinence with prevalence urgency urinary incontinence Women who suffer from advanced POP (POP-Quantification system (POP-Q) stage more than 2) Women with acute urinary tract infection Women with bladder outlet obstruction Women who are not able to give informed consent or participate with this randomized research study for any other reason

Ages Eligible for Study
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Minimum Age: 21 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
Interventional Model Description: Randomized controlled comparative study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Midurethral synthetic tape with tension control mechanism<br> | Procedure: surgical management of stress urinary incontinence with synthetic tape with tension control mechanism.<br>* Standard protocol for the surgical treatment of stress urinary incontinence using a transobturator approach. A absorbing gasket attached to the middle of the tape provides tension control.<br>|
| Active Comparator: midurethral tension free tape<br> | Procedure: surgical management of stress urinary incontinence with midurethral tension free tape.<br>* Standard protocol for the surgical treatment of stress urinary incontinence using a transobturator approach.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcome measured as urogenital distress inventory (UDI-6) will be assessed before and after surgery at 12 weeks and 1 year. | The UDI measures the impact of urinary incontinence on activities, roles, and emotional states in women. This questionnaire presented six questions related to urinary disorders. The patient could answer Not at all, A little bit, Moderately or Greatly, to each of the questions, each answer is evaluated at 0, 1, 2 or 3 points, respectively, and then summed up. The final score means that the greater the sum of the indicators, the worse the patient's condition. This score reflects the condition of the patient before and after surgery at 12 weeks and 1 year. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bladder outlet obstruction measured during urodynamics pressure flow study | When the urodynamic research indicators deviate (Qmax < 12 ml/s and Postvoid residual volume (PVR) > 100 ml, we establish a diagnosis bladder outlet obstruction. | 1 year | 
| Stress cough test measured before and after surgery. | Objective cure rate will be not the leakage at physical examination cough test with full bladder (200-400ml) | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stress urinary incontinence, midurethral tension free tape, patient reported outcome, bladder outlet obstruction, complications, tension control mechanism