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Transobturator Subtrigonal Tape vs Transobturator Suburethral Tape for Stress Urinary Incontinence

NCT02112591 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2019-02-07

No results posted yet for this study

Summary

Introduction:

Minimally invasive procedures TOT (tension-free suburethral tape using transobturator approach)have been the standard for correction of SUI. However, around 28% of these patients exhibit alteration of urinary flow. Recently, in 40 patients who underwent open surgery, an abdominal fascia tape was placed in a subtrigonal position with a success rate of 87.5% without obstruction. Our intention is to make the most of the idea of subtrigonal position in minimally invasive procedures with transobturator polypropylene vaginal tape (S-TOT).

Object of the Study: To evaluate the efficacy and security of S-TOT compared with TOT.

Materials and Methods:

Study Population:

Patients of the Mexican Institute of Social Security (IMSS) with an SUI diagnosis. Eligibility requirements: history of at least 3 months with symptoms of isolated SUI or symptoms of SUI associated with urge urinary incontinence (mixed UI). The size of the sample was estimated 34 subjects are required per group.

Study Design:

It is a parallel group randomized clinical trial. Success (efficacy) will be defined as when the SUI has been corrected with negative pad test and normal urinary flow.

The results (efficacy) will be compared between the two groups using chi2 (group a/b versus success/lack of success). In all cases, p \<0.05 will be considered significant.

The data will be obtained with clinical evaluation, laboratory and radiological/imaging tests and the respective questionnaires during the visits before surgery, and at 2 and 6 weeks, and 6, 12, and 24 months after surgery.

Conditions

  • Stress Urinary Incontinence

Interventions

PROCEDURE

transobturator subtrigonal tape S-TOT

Minimally invasive surgery for placement of suburethral polypropylene tape (TOT), which is widely used around the world and considered the standard of treatment at present, has very limited efficacy when considering the correction of SUI without affecting normal micturition. There is evidence that the placement of autologous fascia tape in subtrigonal position has higher efficacy. Thus, the subtrigonal placement of polypropylene mesh tape through minimally invasive procedures could have higher efficacy.

PROCEDURE

Transobturator suburethral tape (TOT)

Minimally invasive procedures in which needles are inserted via transobturator approach for the placement in mid-urethral position of polypropylene tape that is 1.5cm wide for the treatment of SUI

Sponsors & Collaborators

  • Coordinación de Investigación en Salud, Mexico

    lead OTHER_GOV

Principal Investigators

  • Eduardo A. Serrano-Brambila, MSc · Instituto Mexicano del Seguro Social

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2019-12-31
Completion
2020-02-29

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02112591 on ClinicalTrials.gov