Multicentric Comparative Randomized Study of the Single-incision Sling Ajust® Versus Suburethral Transobturator Slings.
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.
Female Stress Urinary Incontinence.
Device: Ajust sling
Device: Classical transobturator sling
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Multicentric Comparative Randomized Study of the Single-incision Sling Ajust® Versus Suburethral Transobturator Slings.|
- Comparison of the cure rates between the single incision sling Ajust and classical transobturator tapes. [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
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.
- Number of participants with adverse events [ Time Frame: 0, 1, 6 and 12 months after surgery ] [ Designated as safety issue: Yes ]Comparison of the intra- and postoperative complications between procedures
- Change in the Maximal Urethral Closure Pressure. [ Time Frame: One year after surgery. ] [ Designated as safety issue: No ]Comparison of the changes in the Maximal Urethral Closure Pressure (cmH2O) measured preoperatively and 1 year after surgery.
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Experimental group: surgery to treat stress urinary incontinence with the sling Ajust®
|Device: Ajust sling|
Active Comparator: Classical transobturator tape
Control group: surgery to treat stress urinary incontinence with the Align® sling.
Device: Classical transobturator sling
Other Name: Align®
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699425
|Hospital Universitari de Bellvitge|
|Hospitalet, Barcelona, Spain|
|Hospital de Viladecans|
|Viladecans, Barcelona, Spain|
|Hospital de Palamós|
|Palamós, Girona, Spain|
|Hospital Universitari Vall d'Hebron|
|Barcelona, Spain, E-08035|
|Hospital Universitari de Girona Dr. Josep Trueta|