Ease of Use Study of the FemPulse System

Launched by FEMPULSE CORPORATION · Mar 12, 2025

Keywords

ClinConnect Summary

The Ease of Use Study of the FemPulse System is a clinical trial aimed at understanding how well the FemPulse System works for women dealing with Overactive Bladder (OAB) symptoms. OAB is a condition that causes a strong, sudden need to urinate often, which can sometimes lead to accidents. This study is currently looking for women aged 21 and older who have been diagnosed with OAB by a doctor. Participants need to be able to read and understand the study information and agree to follow the study guidelines.

If you qualify for this study, you will be asked to use the FemPulse System and attend regular visits to provide feedback on your experience. It's important to note that certain health issues, like significant pain, neurological conditions, or having specific medical devices like a pacemaker, may prevent someone from participating. Overall, this study hopes to show how easy it is for women to use the FemPulse System to manage their OAB symptoms effectively.

Gender

FEMALE

Eligibility criteria

• Key Inclusion Criteria:
• • 1. 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 .
• • 2. Able to read, comprehend, and reliably provide informed consent and study-related information.
• • 3. Willing and able to comply with study required procedures and visits
• Exclusion Criteria:
• • 1. 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.
• • 2. 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.
• • 4. Systemic condition or disease that may interfere with study participation or not an appropriate study candidate, as determined by study investigator.