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

This study is enrolling participants by invitation only.

Sponsor:

Information provided by:

Federal University of São Paulo

ClinicalTrials.gov Identifier:

NCT01094353

First received: March 24, 2010

Last updated: March 25, 2010

Last verified: March 2010

History of Changes

Purpose

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

Condition	Intervention	Phase
Female Stress Urinary Incontinence	Procedure: minisling ophira™	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Randomised Trial of Ophira™ Minisling System and Unitape™ for the Treatment of Stress Urinary Incontinence in Women

Resource links provided by NLM:

MedlinePlus related topics: Pelvic Support Problems Urinary Incontinence

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:

to assess efficacy between tot with minisling in cure in women with stress urinary incontinence [ Time Frame: one year ] [ Designated as safety issue: Yes ]
to assess efficacy and safety of minisling and transobturator sling in treatment of female stress urinary incontinence

Estimated Enrollment:	50
Study Start Date:	June 2008
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: minisling 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: minisling ophira™ 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: minisling transobturator sling
Active Comparator: transobturator Transobturator sling Unitape™ is an outside-in approach therapeutic option for surgical treatment in women with stress urinary incontinence	Procedure: minisling ophira™ 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: minisling transobturator sling

Detailed Description:

eligibility criteria was : female stress urinary incontinence

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01094353

Locations

Brazil
Federal University of São Paulo
São Paulo, Brazil

Sponsors and Collaborators

Federal University of São Paulo

Investigators

Principal Investigator:

Lucyana m djehdian, Pg

Federal University of São Paulo

More Information

Publications:

De Ridder D, Berkers J, Deprest J, Verguts J, Ost D, Hamid D, Van der Aa F. Single incision mini-sling versus a transobutaror sling: a comparative study on MiniArc and Monarc slings. Int Urogynecol J Pelvic Floor Dysfunct. 2010 Mar 4; [Epub ahead of print]

Responsible Party:	unifesp
ClinicalTrials.gov Identifier:	NCT01094353 History of Changes
Other Study ID Numbers:	ophira
Study First Received:	March 24, 2010
Last Updated:	March 25, 2010
Health Authority:	Brazil: National Health Surveillance Agency

Keywords provided by Federal University of São Paulo:

Urodynamic Stress urinary incontinence
Minisling
Ophira™
Unitape™

Additional relevant MeSH terms:

Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders

Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013

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