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

NCT01699425 | Completed

• 1 other identifier: AJA201205
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

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.

Conditions

Female Stress Urinary Incontinence

Keywords

Stress urinary incontinence.; Suburethral sling.; Single-incision suburethral sling.; Ajust.; Transobturator tape.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of participants with adverse events

  0, 1, 6 and 12 months after surgery

Other Outcomes (1)

• Change in the Maximal Urethral Closure Pressure.

  One year after surgery.

Study Arms (2)

Ajust

EXPERIMENTAL

Experimental group: surgery to treat stress urinary incontinence with the sling Ajust®

Device: Ajust sling

Classical transobturator tape

ACTIVE COMPARATOR

Control group: surgery to treat stress urinary incontinence with the Align® sling.

Device: Classical transobturator sling

Interventions

Ajust sling DEVICE

Ajust

Classical transobturator sling DEVICE

Control group

Also known as: Align®

Classical transobturator tape

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stress urinary incontinence with urethral hypermobility.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (5)

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, E-08035, Spain

Location

Hospital Universitari de Bellvitge

Hospitalet, Barcelona, Spain

Location

Hospital de Viladecans

Viladecans, Barcelona, Spain

Location

Hospital Universitari de Girona Dr. Josep Trueta

Girona, Girona, Spain

Location

Hospital de Palamós

Palamós, Girona, Spain

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2012
• First Posted: October 3, 2012
• Study Start: March 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: March 28, 2017

Record last verified: 2017-03

Locations

ES (5)