Trial Comparing Mini-Arc Precise Pro and the Trans Vaginal Obturator Tape for Stress Urinary Incontinence

This study is not yet open for participant recruitment.
Verified March 2013 by University of Manitoba
Sponsor:
Information provided by (Responsible Party):
Ken Maslow, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01799122
First received: February 22, 2013
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

Randomized comparison of two surgeries for the treatment of female stress urinary incontinence.


Condition Intervention Phase
Stress Urinary Incontinence
Urethral Sling Surgery
Device: Mini Arc Precise Pro and Trans vaginal obturator sling (TVT-0)
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Comparing Mini-Arc Precise Pro and the Trans Vaginal Obturator Tape for Surgical Management of Stress Urinary Incontinence

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Cough test at one year from surgery [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective symptoms, QOL questionaires [ Time Frame: 1 & 2 years post surgery ] [ Designated as safety issue: No ]

Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Precise sling vs TVT-O sling Device: Mini Arc Precise Pro and Trans vaginal obturator sling (TVT-0)

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • women with stress urinary incontinence with a positive cough test
  • patient request surgery for treatment

Exclusion Criteria:

  • prodominantely overactive bladder
  • previous failed procedure
  • MUCP <20 cm H2O
  • presence of vaginal prolapse > stage 1
  • voiding dysfunction (PVR>100 mL)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01799122

Locations
Canada, Manitoba
Ken Maslow Not yet recruiting
Winnipeg, Manitoba, Canada, R2H 2A6
Contact: Ken D Maslow, MD    204-235-3039    kmaslow@sbgh.mb.ca   
Sponsors and Collaborators
University of Manitoba
  More Information

No publications provided

Responsible Party: Ken Maslow, Assistent Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT01799122     History of Changes
Other Study ID Numbers: B2012:047
Study First Received: February 22, 2013
Last Updated: March 13, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 14, 2014