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. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014