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

Primary Purpose

Stress Urinary Incontinence, Urethral Sling Surgery

Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Mini Arc Precise Pro and Trans vaginal obturator sling (TVT-0)
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Ken Maslow

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Precise sling vs TVT-O sling

Arm Description

Outcomes

Primary Outcome Measures

Cough test at one year from surgery

Secondary Outcome Measures

Subjective symptoms, QOL questionaires

Full Information

First Posted
February 22, 2013
Last Updated
January 8, 2016
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT01799122
Brief Title
Trial Comparing Mini-Arc Precise Pro and the Trans Vaginal Obturator Tape for Stress Urinary Incontinence
Official Title
Randomized Clinical Trial Comparing Mini-Arc Precise Pro and the Trans Vaginal Obturator Tape for Surgical Management of Stress Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence, Urethral Sling Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3

8. Arms, Groups, and Interventions

Arm Title
Precise sling vs TVT-O sling
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Mini Arc Precise Pro and Trans vaginal obturator sling (TVT-0)
Primary Outcome Measure Information:
Title
Cough test at one year from surgery
Time Frame
One year
Secondary Outcome Measure Information:
Title
Subjective symptoms, QOL questionaires
Time Frame
1 & 2 years post surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Facility Information:
Facility Name
Ken Maslow
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ken D Maslow, MD
Phone
204-235-3039
Email
kmaslow@sbgh.mb.ca

12. IPD Sharing Statement

Learn more about this trial

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

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