A Comparative Study Minisling Versus Transobturator (TOT)Sling (sui)

June 19, 2017 updated by: Ana Livia Garcia Pascom, Federal University of São Paulo

Randomised Trial of Ophira™ Minisling System and Unitape™ for the Treatment of Stress Urinary Incontinence in Women

A study to compare efficacy in surgical treatment for SUI (Stress Urinary Incontinence), tot with minisling.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

eligibility criteria was : female stress urinary incontinence

Study Type

Interventional

Enrollment (Actual)

145

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil
        • Federal University of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • clinical and urodynamic diagnosis of SUI in patients between 18 and 90 years

Exclusion Criteria:

  • postvoid residual urine volume more than 100 ml, coagulation disorders, current urinary tract infection, sequelae of previous radiation therapy of the pelvis, anticoagulant therapy, vulvovaginitis, and anesthesia contraindication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Mini-sling
The minisling Ophira™ is a new intervention therapeutic option for surgical treatment in women with stress urinary incontinence. It is made of polypropylene monofilament mesh, held between two self-anchoring polypropylene columns in a fishbone design connected to two delivering needles.
Procedure: Mini-sling
The minisling is a new intervention therapeutic option for surgical treatment in women with stress urinary incontinence. It is made of polypropylene monofilament mesh, held between two self-anchoring polypropylene columns in a fishbone design connected to two delivering needles.
Other Names:
  • Mini-sling Ophira™
ACTIVE_COMPARATOR: Transobturator
Transobturator sling Unitape™ is an outside-in approach therapeutic option for surgical treatment in women with stress urinary incontinence
Procedure: Transobturator
Transobturator sling Unitape™ is an outside-in approach therapeutic option for surgical treatment in women with stress urinary incontinence
Other Names:
  • Transobturator Sling Unitape™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to assess efficacy between tot with minisling in cure in women with stress urinary incontinence
Time Frame: one year
to assess efficacy and safety of minisling and transobturator sling in treatment of female stress urinary incontinence
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Principal Investigator: Ana LG Pascom, Pg, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2008

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

July 1, 2015

Study Registration Dates

First Submitted

March 24, 2010

First Submitted That Met QC Criteria

March 25, 2010

First Posted (ESTIMATE)

March 26, 2010

Study Record Updates

Last Update Posted (ACTUAL)

June 21, 2017

Last Update Submitted That Met QC Criteria

June 19, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ophira

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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