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Completed

NCT Number: NCT01094353

A Comparative Study Minisling Versus Transobturator (TOT)Sling

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

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Key information

Conditions

Female Stress Urinary Incontinence

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Federal University of São Paulo

São Paulo, Brazil

About this study

eligibility criteria was : female stress urinary incontinence

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mini-sling

Procedure

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™

Transobturator

Procedure

Transobturator sling Unitape™ is an outside-in approach therapeutic option for surgical treatment in women with stress urinary incontinence

Other names: Transobturator Sling Unitape™

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Acronym: sui

Important dates

Study start
2008
Primary completion
2011
Study completion
2015
First posted
Mar 26, 2010
Registry last updated
Jun 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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