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Radiofrequency

Active treatment for Stress Urinary Incontinence (PURSUIT Trial)

N/A

Waitlist Available

Led By Eric S Rovner, MD

Research Sponsored by Viveve Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6, 9, and 12 months

Awards & highlights

PURSUIT Trial Summary

This trial is testing a new treatment for stress urinary incontinence in women. 390 subjects will be given either the active treatment or a sham treatment, and the trial will last for 12 months. The primary objective is to see if the new treatment improves stress urinary incontinence better than the sham treatment.

Eligible Conditions

Stress Urinary Incontinence

PURSUIT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6, 9, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6, 9, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 9, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

1-hour pad weight test

3-day diary

Incontinence Quality of Life (I-QOL)

+3 more

PURSUIT Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active ArmExperimental Treatment1 Intervention

Active arm delivers radiofrequency and cryogen

Group II: Sham ComparatorPlacebo Group1 Intervention

Sham delivers non therapeutic levels of radiofrequency and cryogen

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Active treatment

2010

Completed Phase 1

~70

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Viveve Inc.Lead Sponsor

5 Previous Clinical Trials

583 Total Patients Enrolled

Eric S Rovner, MDPrincipal InvestigatorMedical University of South Carolina

Roger R Dmochowski, MDStudy DirectorVanderbilt University Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research study currently open for recruitment?

"Clinicaltrials.gov confirms that this experiment is currently seeking out participants, having initially been published on the 11th of January 2021 and edited most recently on the 19th July 2021."

Answered by AI

What is the cap on enrolment for this clinical trial?

"The sponsor, Viveve Inc., requires 390 eligible participants to successfully complete their trial. The two primary recruitment sites are Minnesota Women's Care, P.A. in Maplewood and The Clinical Trial Center, LLC in Jenkintown, Pennsylvania."

Answered by AI

In how many distinct locations is this trial being conducted?

"Currently, prospective participants are being recruited at 27 different healthcare facilities. These clinics are based in Maplewood, Jenkintown and Lake City as well as 24 other centres across the nation. To minimize travel strain during your participation it is important to pick a clinic nearest you."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prospective US Radiofrequency SUI Trial

2021. "Prospective US Radiofrequency SUI Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04720352.