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.
- Stress Urinary Incontinence
Treatment Effectiveness
Effectiveness Progress
Study Objectives
0 Primary · 6 Secondary · Reporting Duration: 3, 6, 9, and 12 months
Trial Safety
Safety Progress
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
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · Female Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
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." - Anonymous Online Contributor
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
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