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

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.

Study Overview

• Status: Completed
• Conditions: Female Stress Urinary Incontinence
• Intervention / Treatment: Device: Ajust sling; Device: Classical transobturator sling

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, E-08035
    • Hospital Universitari Vall d'Hebron
  • Girona, Spain
    • Hospital Universitari de Girona Dr. Josep Trueta
  • Barcelona
    • Hospitalet, Barcelona, Spain
      • Hospital Universitari de Bellvitge
    • Viladecans, Barcelona, Spain
      • Hospital de Viladecans
  • Girona
    • Palamós, Girona, Spain
      • Hospital de Palamós

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Align®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the cure rates between the single incision sling Ajust and classical transobturator tapes.	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.	Up to one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events	Comparison of the intra- and postoperative complications between procedures	0, 1, 6 and 12 months after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Maximal Urethral Closure Pressure.	Comparison of the changes in the Maximal Urethral Closure Pressure (cmH2O) measured preoperatively and 1 year after surgery.	One year after surgery.

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Collaborators: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta; Hospital Universitari de Bellvitge; Hospital de Viladecans; Serveis de Salut Integrats Baix Empordà

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: September 22, 2012
• First Submitted That Met QC Criteria: September 30, 2012
• First Posted (Estimate): October 3, 2012

Study Record Updates

• Last Update Posted (Actual): March 28, 2017
• Last Update Submitted That Met QC Criteria: March 27, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Stress urinary incontinence.; Suburethral sling.; Single-incision suburethral sling.; Ajust.; Transobturator tape.
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: AJA201205