Female Stress Urinary Incontinence
Conditions
Keywords
Stress urinary incontinence., Suburethral sling., Single-incision suburethral sling., Ajust., Transobturator tape.
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.
Interventions
DEVICEAjust sling
DEVICEClassical transobturator sling
Control group
Sponsors
Hospital Universitari de Bellvitge
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Hospital de Viladecans
Serveis de Salut Integrats Baix Empordà
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the cure rates between the single incision sling Ajust and classical transobturator tapes. | Up to one year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events | 0, 1, 6 and 12 months after surgery | Comparison of the intra- and postoperative complications between procedures |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in the Maximal Urethral Closure Pressure. | One year after surgery. | Comparison of the changes in the Maximal Urethral Closure Pressure (cmH2O) measured preoperatively and 1 year after surgery. |
Countries
Spain
Outcome results
None listed