Female Stress Urinary Incontinence Clinical Trial
Official title:
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.
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