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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01799122
Enrollment
Unknown
Registered
2013-02-26
Start date
Unknown
Completion date
Unknown
Last updated
2016-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Urinary Incontinence, Urethral Sling Surgery

Brief summary

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

Interventions

DEVICEMini Arc Precise Pro and Trans vaginal obturator sling (TVT-0)

Sponsors

University of Manitoba
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
Cough test at one year from surgeryOne year

Secondary

MeasureTime frame
Subjective symptoms, QOL questionaires1 & 2 years post surgery

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026