Transobturator Sling Compared With Single-incision Mini-sling for the Treatment of Stress Urinary Incontinence

Not Applicable

Completed

• Conditions: Injury Due to Sling-shot
• Interventions: Device: Ophira; Device: Transobturator sling

• Registration Number: NCT02540525
• Lead Sponsor: Faculdade de Medicina do ABC

Brief Summary

1. OBJECTIVE:

To determine the efficacy and safety of a single-incision mini-sling compared with a transobturator midurethral sling for stress urinary incontinence (SUI) treatment.

2. METHODS:

This prospective single-center randomized controlled trial will involve 100 women with a diagnosis of SUI. Primary outcomes were the objective and subjective cure rates, defined as negative cough stress and pad tests, and satisfaction rates. Quality of life assessed by the Incontinence Quality of Life Questionnaire and the Urogenital Distress Inventory Short Form, operation time, complications, and reoperation rates were also recorded. The efficacy was analyzed using a noninferiority test with a margin of 15%. For the noninferiority test, a P value \>.05 rejects the noninferiority hypothesis of the mini-sling.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2014-01
• Study First Submitted: 2014-02-22
• Study Completion: 2014-07
• Status Verified: 2015-09
• Study First Submitted QC: 2015-09-01
• Last Update Submitted: 2015-09-01
• Study First Posted: 2015-09-04
• Last Update Posted: 2015-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Patients aged over 18 years
• Clinical and urodynamic diagnosis of stress urinary incontinence
• Absence of associated neurological diseases
• No clinically significant detrusor instability (ie, to determine which symptoms are proportionally more significant for patient incontinence efforts)

Exclusion Criteria

• urodynamic changes suggesting a reduction in bladder capacity, bladder compliance or suggestive of bladder outlet obstruction
• Coagulopathies
• Pregnancy
• History of sensitivity to foreign body
• Acute Urinary Tract Infection
• Sequelae of high exposure to ionizing radiation
• Use of drugs that can result in high and / or risk of significant postoperative complications surgical risk, including any drug that interferes with blood clotting
• anesthetic contraindication to the procedure
• Vulvovaginitis: presence of vaginal discharge with laboratory proven infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single incision mini-sling	Ophira	Experimental group: surgery to treat stress urinary incontinence with the Ophira mini sling systemt®
Transobturator sling	Transobturator sling	Control group: surgery to treat stress urinary incontinence with the Unitape T Plus®.

Primary Outcome Measures

Name	Time	Method
Comparison of the cure rates between the mini sling and classical transobturator tapes	Up to one year	Percentage of patients who are regarded as cured or improved based on the following criteria: * Negative Cough Stress test 1 year after surgery; * Pad Test \< 2 g 1 year after surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Medicine of ABC; 🇧🇷 Santo André, São Paulo, Brazil