Multicentric Comparative Randomized Study of the Single-incision Sling Ajust® Versus Suburethral Transobturator Slings.

Study Overview
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Brief Summary
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The transobturator tension-free vaginal tape (TOT) procedure has demonstrated high cure rates comparable to those obtained by retropubic suburethral tape, becoming the first line treatment for stress urinary incontinence (SUI) in many cases. The TOT procedure is not exempt from complications such as bleeding, bladder injuries and pain in the thigh/groin. In addition it is commonly performed under general or regional anesthesia1-3. The single-incision mini-slings (SIMS) were developed to reduce the risk of complications by avoiding the blind passage of the trocars through the obturator space. In addition, the use of SIMS could enable surgeons to perform the procedure truly under local anesthesia. Different devices for SIMS procedure are available. However, the evidence about their efficacy is controversial4-7. The main limitation of these devices could be the predetermined length of the mesh and the weakness on its fixation. The design of the SIMS Ajust® allows adjusting the length of the sling to each individual woman and provides a robust fixation into the obturator membrane. Recent prospective studies on the efficacy and safety of the sling Ajust® have obtained promising results8,9. Even so, the NICE guidelines advise to use SIMS in the context of research studies10. The objective of this study is to establish if the effectiveness of the SIMS Ajust® is non-inferior to that of a standard TOT, as well as to compare the comorbidity of both procedures. Owing to the new appearance and fast evolution of these procedures, randomized comparative studies with SIMS are required in order to determine its place in the treatment of SUI.

Official Title
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Multicentric Comparative Randomized Study of the Single-incision Sling Ajust® Versus Suburethral Transobturator Slings.

Conditions
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Female Stress Urinary Incontinence

Intervention / Treatment
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* Device: Ajust sling
* Device: Classical transobturator sling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stress urinary incontinence with urethral hypermobility. Exclusion Criteria: Incapacity to understand the information or give their consent. Previous anti-incontinence surgery with slings. Urethral hypomobility (Q-tip test <30º). Low pressure urethra (MUCP < 20cmH2O). Detrusor overactivity.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ajust<br>Experimental group: surgery to treat stress urinary incontinence with the sling Ajust® | Device: Ajust sling<br> <br> |
| Active Comparator: Classical transobturator tape<br>Control group: surgery to treat stress urinary incontinence with the Align® sling. | Device: Classical transobturator sling<br>* Control group<br>* Other names: Align®;|

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 single incision sling Ajust and classical transobturator tapes. | Percentage of patients who are regarded as cured or improved based on the following criteria: Improvement on the International consultation on Incontinence Urinary Questionnaire-Short Form 1 year after the surgery. Negative Cough Stress test 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 urinary incontinence., Suburethral sling., Single-incision suburethral sling., Ajust., Transobturator tape.