FemPulse System for Overactive Bladder

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: FemPulse Corporation

No Placebo Group

Trial Summary

What is the purpose of this trial?The objective of the study is to demonstrate that the FemPulse System can be used as indicated

Eligibility Criteria

This trial is for females over 21 with a cervix who have been diagnosed with Overactive Bladder (OAB) by a physician. Participants must be able to understand and consent to the study's procedures. Those with metal pelvic implants, active medical devices like pacemakers, or significant health conditions that could affect participation are excluded.

Inclusion Criteria

Able to read, comprehend, and reliably provide informed consent and study-related information

Willing and able to comply with study required procedures and visits

I am a woman over 21 with doctor-confirmed OAB symptoms.

Exclusion Criteria

Systemic condition or disease that may interfere with study participation or not an appropriate study candidate, as determined by study investigator

Any significant pain, neurologic, psychological condition or other factors, that in the investigator's judgment, might confound the protocol study assessments, and adherence to the protocol

Has a metal pelvic implant or an active implantable medical device, including but not limited to a cardiac pacemaker, cardioverter-defibrillator or neurostimulator

+1 more

Participant Groups

The FemPulse System is being tested in this study. The goal is to show that it can be used as intended for women experiencing symptoms of OAB such as urinary urgency, frequency, nocturia, and possibly incontinence.

1Treatment groups

Experimental Treatment

Group I: Subjects receiving the FemPulse SystemExperimental Treatment1 Intervention

Subjects to receive the FemPulse System consisting of a non-implanted, vaginal electrical stimulation device (Ring) and other patient accessories.