CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 38 enrolled
Drug / intervention
Viveve - Active +2 moredevice
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/NCT04206085
NCT04206085N/ACompleted
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Comparison of the Viveve Treatment and Cryogen-Only Treatment Versus Sham Treatment for Stress Urinary Incontinence

Viveve Inc.·interventional·Posted Dec 20, 2019·Updated Sep 21, 2022

In Brief

A clinical study evaluating Viveve - Active, Viveve - Cryogen-Alone, and 1 other intervention for Stress Urinary Incontinence. Completed, enrolled 38 participants across 3 sites.

Detailed Summary

This is a prospective, randomized, single-blind, study comparing both the Viveve Treatment (RF plus cryogen) and cryogen alone treatment versus sham treatment in patients with mild to moderate stress urinary incontinence.

Study Details

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

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedDec 20, 2019
Enrollment StartJan 1, 2020
Primary CompletionAug 30, 2020
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 6.5 years ago

Interventions

Viveve - Activedevice

Radiofrequency and Cryogen-Cooling

Viveve - Cryogen-Alonedevice

Cryogen-Cooling

Viveve - Shamdevice

Sham