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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01094353
First Posted: March 26, 2010
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ana Livia Garcia Pascom, Federal University of São Paulo
  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: Mini-sling Procedure: Transobturator Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Clinical, prospective, single-center, randomized controlled trial comparing the efficacy and safety of a single-incision mini-sling and a transobturator midurethral sling for female stress urinary incontinence (SUI) treatment.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
The participants were randomly allocated to a single-incision mini-sling or a transobturator midurethral tape by a simple randomization procedure using a random number generator computer program. Randomization was performed at the moment of inclusion by a nurse blinded to women's histories. Group assign- ment was concealed in consecutively numbered, sealed, opaque envelopes that were opened in the operating room just before the procedure.
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 Ana Livia Garcia Pascom, 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 ]
    to assess efficacy and safety of minisling and transobturator sling in treatment of female stress urinary incontinence


Enrollment: 145
Actual Study Start Date: June 2008
Study Completion Date: July 2015
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Transobturator Sling Unitape™

Detailed Description:
eligibility criteria was : female stress urinary incontinence
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094353


Locations
Brazil
Federal University of São Paulo
São Paulo, Brazil
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Ana LG Pascom, Pg Federal University of São Paulo
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ana Livia Garcia Pascom, M.D., Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01094353     History of Changes
Other Study ID Numbers: ophira
First Submitted: March 24, 2010
First Posted: March 26, 2010
Last Update Posted: October 12, 2017
Last Verified: June 2017

Keywords provided by Ana Livia Garcia Pascom, Federal University of São Paulo:
Urodynamic Stress urinary incontinence
Minisling
Ophira™
Unitape™

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders