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NCT01799122 Clinical Trial

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

Stress Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01799122
Other study ID # B2012:047
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received February 22, 2013
Last updated January 8, 2016

Study information
Verified date January 2016
Source University of Manitoba
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 0
Est. completion date
Est. primary completion date February 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years and older
Eligibility 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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Mini Arc Precise Pro and Trans vaginal obturator sling (TVT-0)

Locations
Country Name City State
Canada Ken Maslow Winnipeg Manitoba

Sponsors (1)
Lead Sponsor Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cough test at one year from surgery One year No
Secondary Subjective symptoms, QOL questionaires 1 & 2 years post surgery No
See also
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Completed NCT01924728 - Efficacy of Magnetic Stimulation for Stress Urinary Incontinence N/A
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Unknown status NCT01455779 - Lyrette: Renewing Continence Objective and Subjective Efficacy Study N/A
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Completed NCT01770691 - Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence N/A
Completed NCT01123096 - Is the Cough Stress Test Equivalent to the 24 Hour Pad Test in the Assessment of Stress Incontinence? N/A
Completed NCT00234754 - Trans-Obturator Tape Versus Trans-Vaginal Tape for Stress Urinary Incontinence in Women N/A
Completed NCT00441454 - Retropubic vs. Transobturator Tension-free Vaginal Tape N/A
Completed NCT03985345 - Prospective Evaluation of the Connected EMY Biofeedback Probe in the Management of Stress Urinary Incontinence. N/A
Active, not recruiting NCT03671694 - Laser Vaginal Treatment for SUI N/A
Completed NCT04097288 - Effects of Single Dose Citalopram and Reboxetine on Urethral and Anal Closure Function on Healthy Female Subjects Phase 1