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Study of Non-Ablative Radiofrequency Treatment for Stress Urinary Incontinence

NCT03066180 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2018-12-19

No results posted yet for this study

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.

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

Viveve SUI treatment

Non-ablative radiofrequency treatment with surface cooling

Sponsors & Collaborators

  • Dr. Bruce B. Allan

    lead OTHER

Principal Investigators

  • Bruce B Allan, PhD, MD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-29
Primary Completion
2018-11-30
Completion
2018-11-30
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 NCT03066180 on ClinicalTrials.gov