Multicentric Comparative Randomized Study of the Single-incision Sling Ajust® Versus Suburethral Transobturator Slings.
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Female Stress Urinary Incontinence. |
Device: Ajust sling Device: Classical transobturator sling |
Phase 4 |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 140 |
| Study Start Date: | October 2012 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ajust
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
Control group
Other Name: Align®
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Female |
| Accepts 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.
Contacts and Locations| Contact: Jose Luis Poza, MD | 34-93-489-30-00 ext 3066 | jlpoza@vhebron.net |
| Spain | |
| Hospital Universitari de Bellvitge | Not yet recruiting |
| Hospitalet, Barcelona, Spain | |
| Principal Investigator: Miriam Campos, MD | |
| Hospital de Viladecans | Not yet recruiting |
| Viladecans, Barcelona, Spain | |
| Principal Investigator: Marta Palau-Jané, MD | |
| Hospital de Palamós | Not yet recruiting |
| Palamós, Girona, Spain | |
| Principal Investigator: Eliana Castañeda, MD | |
| Hospital Universitari Vall d'Hebron | Not yet recruiting |
| Barcelona, Spain, E-08035 | |
| Contact: Jose Luis Poza, MD 34.93.489.30.00 ext 3066 jlpoza@vhebron.net | |
| Principal Investigator: Jose Luis Poza, MD | |
| Sub-Investigator: Jordi Sabadell, MD | |
| Hospital Universitari de Girona Dr. Josep Trueta | Not yet recruiting |
| Girona, Spain | |
| Principal Investigator: Fernando Montero, MD | |
More Information
No publications provided
| Responsible Party: | Hospital Universitari Vall d'Hebron Research Institute |
| ClinicalTrials.gov Identifier: | NCT01699425 History of Changes |
| Other Study ID Numbers: | AJA201205 |
| Study First Received: | September 22, 2012 |
| Last Updated: | September 30, 2012 |
| Health Authority: | Spain: Ethics Committee |
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
|
Stress urinary incontinence. Suburethral sling. Single-incision suburethral sling. Ajust. Transobturator tape. |
Additional relevant MeSH terms:
|
Urinary Incontinence Urinary Incontinence, Stress Urination Disorders |
Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013