CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 37 enrolled
Drug / intervention
Viveve SUI treatmentdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03066180
NCT03066180N/ACompleted
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Pilot Study of Non-Ablative Radiofrequency Treatment for Stress Urinary Incontinence

Dr. Bruce B. Allan·interventional·Posted Feb 28, 2017·Updated Dec 19, 2018

In Brief

A clinical study evaluating Viveve SUI treatment for Stress Urinary Incontinence. Completed, enrolled 37 participants across 1 site.

Detailed Summary

This is a prospective, pilot clinical study involving two study groups. This study is designed to demonstrate that the study treatment meets primary efficacy and safety endpoints. The treatment involves radiofrequency treatment to address symptoms of stress urinary incontinence. After receiving the study treatment, subjects will be followed out to 12 months post-treatment. At the Screening Visit, and at each designated follow-up timepoint, subjects will be asked to complete a variety of questionnaires, provide a patient diary, and undergo an objective assessment for urine loss.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStress Urinary Incontinence
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 28, 2017
Enrollment StartMay 29, 2017
Primary CompletionNov 30, 2018
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.3 years ago

Interventions

Viveve SUI treatmentdevice

Non-ablative radiofrequency treatment with surface cooling