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

January 8, 2016 updated by: Ken Maslow, University of Manitoba

Randomized Clinical Trial Comparing Mini-Arc Precise Pro and the Trans Vaginal Obturator Tape for Surgical Management of Stress Urinary Incontinence

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • Ken Maslow

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Precise sling vs TVT-O sling
Device: Mini Arc Precise Pro and Trans vaginal obturator sling (TVT-0)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cough test at one year from surgery
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Subjective symptoms, QOL questionaires
Time Frame: 1 & 2 years post surgery
1 & 2 years post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (ANTICIPATED)

February 1, 2017

Study Registration Dates

First Submitted

February 22, 2013

First Submitted That Met QC Criteria

February 22, 2013

First Posted (ESTIMATE)

February 26, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 12, 2016

Last Update Submitted That Met QC Criteria

January 8, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2012:047

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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