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Comparison of the Viveve Treatment and Cryogen-Only Treatment Versus Sham Treatment for Stress Urinary Incontinence

NCT04206085 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2022-09-21

Study results available
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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.

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

Viveve - Active

Radiofrequency and Cryogen-Cooling

DEVICE

Viveve - Cryogen-Alone

Cryogen-Cooling

DEVICE

Viveve - Sham

Sham

Sponsors & Collaborators

  • Viveve Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2020-08-30
Completion
2020-08-30
FDA Device
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04206085 on ClinicalTrials.gov