Ease of Use Study of the FemPulse System

Not Applicable

Recruiting

• Conditions: Overactive Bladder (OAB)

• Registration Number: NCT06885099
• Lead Sponsor: FemPulse Corporation

Brief Summary

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

Detailed Description

The objective of the study is to demonstrate that the FemPulse System can be used as indicated in the Patient and Clinician Instructions for Use (IFU), as applicable.

Study Timeline

• Study Start: 2025-02-11
• Study First Submitted: 2025-02-11
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-12
• Last Update Submitted: 2025-03-12
• Study First Posted: 2025-03-20
• Last Update Posted: 2025-03-20
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

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.

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Patient Usability of System	2 days	A survery will be conducted to determine the overall usability of the system

Trial Locations

Locations (1)

Holy Cross Women's Hospital; 🇺🇸 Fort Lauderdale, Florida, United States