FemPulse Therapy First-in-Human Experience

Completed · Not applicable · Has a placebo group

Conditions studied: Urinary Bladder, Overactive

In brief

The purpose of this clinical trial is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.

Key facts

Study ID

NCT03874637

Run by

FemPulse Corporation

People needed

15

Starts

2017-02-14

Expected to finish

2017-05-17

Last updated by the study team

2019-03-14

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Females ≥21 yrs with Overactive Bladder

You may not qualify if…

• Is or was recently pregnant
• Has a metal pelvic implant or any electrically active implanted medical device
• Has a urinary tract or vaginal infection
• Had a previous hysterectomy, pelvic radiation or pelvic cancer
• Has significant pelvic organ prolapse
• Had bladder treatment with onabotulinumtoxinA in the previous 12 months or Tibial Nerve stimulation within the previous 30 days
• Has a significant heart condition or a history of vasovagal reaction or low blood pressure

Where it is running

• Minnesota Urology — Woodbury, Minnesota, United States
• University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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