Active treatment for Stress Urinary Incontinence

Phase-Based Progress Estimates
The Clinical Trial Center, LLC, Jenkintown, PAStress Urinary IncontinenceActive treatment - Device
What conditions do you have?

Study 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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

0 Primary · 6 Secondary · Reporting Duration: 3, 6, 9, and 12 months

3 and 6 months
1-hour pad weight test
Month 12
Incontinence Quality of Life (I-QOL)
International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF)
Medical, Epidemiologic, and Social aspects of Aging (MESA) questionnaire
Patient Global Impression of Improvement (PGI-I)
Month 12
3-day diary

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Active Arm
1 of 2
Sham Comparator
1 of 2

Experimental Treatment

Non-Treatment Group

390 Total Participants · 2 Treatment Groups

Primary Treatment: Active treatment · Has Placebo Group · N/A

Active Arm
Experimental Group · 1 Intervention: Active treatment · Intervention Types: Device
Sham Comparator
ShamComparator Group · 1 Intervention: Sham · Intervention Types: Device
First Studied
Drug Approval Stage
How many patients have taken this drug
Active treatment
Completed Phase 1

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3, 6, 9, and 12 months

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

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have symptoms of a stress disorder, but not a mixed disorder.
You are willing to comply with study requirements and instructions.
You have a positive Q-tip test at the Baseline Visit.
You are able to understand and have voluntarily signed and dated the most current informed consent form (ICF) prior to initiation of any screening or study-specific procedures.
You have symptoms of urinary incontinence for 6 months or longer.
A >10 g pad weight increase from the pre-test pad weight is a positive test for PTH.

Frequently Asked Questions

Is this research study currently open for recruitment?

" 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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.