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

Phase 3

• Conditions: Stress Urinary Incontinence; Urethral Sling Surgery
• Interventions: Device: Mini Arc Precise Pro and Trans vaginal obturator sling (TVT-0)

• Registration Number: NCT01799122
• Lead Sponsor: University of Manitoba

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-22
• Study First Submitted QC: 2013-02-22
• Study First Posted: 2013-02-26
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-08
• Last Update Posted: 2016-01-12
• Primary Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Precise sling vs TVT-O sling	Mini Arc Precise Pro and Trans vaginal obturator sling (TVT-0)	-

Primary Outcome Measures

Name	Time	Method
Cough test at one year from surgery	One year

Secondary Outcome Measures

Name	Time	Method
Subjective symptoms, QOL questionaires	1 & 2 years post surgery

Trial Locations

Locations (1)

Ken Maslow; 🇨🇦 Winnipeg, Manitoba, Canada