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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01699425
First Posted: October 3, 2012
Last Update Posted: March 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Hospital Universitari de Bellvitge
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Hospital de Viladecans
Hospital de Palamós
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute
  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
Female Stress Urinary Incontinence Device: Ajust sling Device: Classical transobturator sling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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 ]

    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 ]
    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. ]
    Comparison of the changes in the Maximal Urethral Closure Pressure (cmH2O) measured preoperatively and 1 year after surgery.


Enrollment: 60
Study Start Date: March 2013
Study Completion Date: May 2016
Primary Completion Date: April 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01699425


Locations
Spain
Hospital Universitari de Bellvitge
Hospitalet, Barcelona, Spain
Hospital de Viladecans
Viladecans, Barcelona, Spain
Hospital de Palamós
Palamós, Girona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain, E-08035
Hospital Universitari de Girona Dr. Josep Trueta
Girona, Spain
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Hospital Universitari de Bellvitge
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Hospital de Viladecans
Hospital de Palamós
  More Information

Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT01699425     History of Changes
Other Study ID Numbers: AJA201205
First Submitted: September 22, 2012
First Posted: October 3, 2012
Last Update Posted: March 28, 2017
Last Verified: March 2017

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
Enuresis
Surgical Wound
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Wounds and Injuries