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

Female Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01699425
• Other study ID #: AJA201205
• Status: Completed
• Phase: N/A
• First received: September 22, 2012
• Last updated: March 27, 2017
• Start date: March 2013
• Est. completion date: May 2016

Study information

• Verified date: March 2017
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Female Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Ajust sling

• Classical transobturator sling
Control group

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitari de Girona Dr. Josep Trueta	Girona
Spain	Hospital Universitari de Bellvitge	Hospitalet	Barcelona
Spain	Hospital de Palamós	Palamós	Girona
Spain	Hospital de Viladecans	Viladecans	Barcelona

Sponsors (5)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute	Hospital de Palamós, Hospital de Viladecans, Hospital Universitari de Bellvitge, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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	Number of participants with adverse events	Comparison of the intra- and postoperative complications between procedures	0, 1, 6 and 12 months after surgery