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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Hospital Universitari Vall d'Hebron Research Institute
Sponsor:
Collaborators:
Hospital Universitari de Bellvitge
Hospital Universitari de Girona Dr. Josep Trueta
Hospital de Viladecans
Hospital de Palamós
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT01699425
First received: September 22, 2012
Last updated: April 10, 2014
Last verified: April 2014
  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.

Resource links provided by NLM:


Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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: March 2013
Estimated Primary Completion Date: March 2015 (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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01699425

Contacts
Contact: Jose Luis Poza, MD 34-93-489-30-00 ext 3066 jlpoza@vhebron.net

Locations
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 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         
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Hospital Universitari de Bellvitge
Hospital Universitari de Girona Dr. Josep Trueta
Hospital de Viladecans
Hospital de Palamós
  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: April 10, 2014
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
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014