NCT03066180

Study of Non-Ablative Radiofrequency Treatment for Stress Urinary Incontinence

Completed NA Last updated 19 December 2018

What this trial tests

NA trial testing Viveve SUI treatment in Stress Urinary Incontinence in 37 participants. Completed in 30 November 2018.

Timeline

29 May 2017

Primary endpoint
30 November 2018

30 November 2018

Quick facts

Lead sponsor	Dr. Bruce B. Allan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	37
Start date	29 May 2017
Primary completion	30 November 2018
Estimated completion	30 November 2018
Sites	1 location across Canada

Drugs / interventions tested

• Viveve SUI treatment

Conditions studied

• Stress Urinary Incontinence — all drugs for Stress Urinary Incontinence →

Sponsor

Dr. Bruce B. Allan

Who can join

18 and older, female only, with Stress Urinary Incontinence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Early Feasibility Study to Evaluate the Viveve System for Female Stress Urinary Incontinence: Interim 6-Month Report.
   Allan BB, Bell S, Husarek K. · · 2020 · cited 4× · PMID 31464548 · DOI 10.1089/jwh.2018.7567