CompletedNot Applicable

Ease of Use Study of the FemPulse System

United States11 participantsStarted 2025-02-11

Plain-language summary

The objective of the study is to demonstrate that the FemPulse System can be used as indicated

Age range21 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Females, defined as a person with a cervix, ≥21 years old, with OAB symptoms, as confirmed by a physician. OAB is defined by urinary urgency, usually with urinary frequency and nocturia, with or without urgency urinary incontinence with symptoms .
✓. Able to read, comprehend, and reliably provide informed consent and study-related information.
✓. Willing and able to comply with study required procedures and visits

✕. 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 3 History of a cardiac condition including, but not limited to, clinically significant abnormal ECG or arrhythmia that may interfere with study participation as determined by investigator.

Patient Usability of System

Timeframe: 2 days

NCT IDNCT06885099

SponsorFemPulse Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-31