Clinical trial NCT01699425: Multicentric Comparative Randomized Study of the Single-incision Sling Ajust® Versus Suburethral Transobturator Slings.
Official title: Multicentric Comparative Randomized Study of the Single-incision Sling Ajust® Versus Suburethral Transobturator Slings.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Stress Urinary Incontinence
Keywords: Stress urinary incontinence.
Suburethral sling.
Single-incision suburethral sling.
Ajust.
Transobturator tape.
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Hospital Universitari de Bellvitge
name: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
name: Hospital de Viladecans
name: Serveis de Salut Integrats Baix Empordà
First posted: 2012-10-03
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of the cure rates between the single incision sling Ajust and classical transobturator tapes.
timeFrame: Up to one year
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: 0, 1, 6 and 12 months after surgery
Other outcomes:
measure: Change in the Maximal Urethral Closure Pressure.
timeFrame: One year after surgery.
Locations:
city: Hospitalet
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Viladecans
country: Spain
facility: Hospital de Viladecans
state: Barcelona
city: Palamós
country: Spain
facility: Hospital de Palamós
state: Girona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Girona
country: Spain
facility: Hospital Universitari de Girona Dr. Josep Trueta
Study officials:
References: