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

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ClinicalTrials.gov Identifier: NCT01799122
Recruitment Status : Unknown
Verified January 2016 by Ken Maslow, University of Manitoba.
Recruitment status was:  Not yet recruiting
First Posted : February 26, 2013
Last Update Posted : January 12, 2016
Sponsor:
Information provided by (Responsible Party):
Ken Maslow, University of Manitoba

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

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

Study Type : Interventional  (Clinical Trial)
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
Estimated Primary Completion Date : February 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Precise sling vs TVT-O sling Device: Mini Arc Precise Pro and Trans vaginal obturator sling (TVT-0)



Primary Outcome Measures :
  1. Cough test at one year from surgery [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Subjective symptoms, QOL questionaires [ Time Frame: 1 & 2 years post surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes 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)

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): 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

Responsible Party: Ken Maslow, Assistent Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT01799122     History of Changes
Other Study ID Numbers: B2012:047
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016

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