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

Vall d'Hebron University Hospital (HUVH)

Status: Completed

Conditions: Female Stress Urinary Incontinence

Treatments: Device: Ajust sling; Device: Classical transobturator sling

Study type: Interventional

Funder types: Other

Identifiers

NCT01699425

AJA201205

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Ajust

Experimental group

Description:

Experimental group: surgery to treat stress urinary incontinence with the sling Ajust®

Treatment:

Device: Ajust sling

Classical transobturator tape

Active Comparator group

Description:

Control group: surgery to treat stress urinary incontinence with the Align® sling.

Treatment:

Device: Classical transobturator sling