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
  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:


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
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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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014