NCT06885099CompletedNot Applicable
Ease of Use Study of the FemPulse System
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- FemPulse Corporation
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Patient Usability of System
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
- •4. Systemic condition or disease that may interfere with study participation or not an appropriate study candidate, as determined by study investigator.
Arms & Interventions
Subjects receiving the FemPulse System
Experimental
Subjects to receive the FemPulse System consisting of a non-implanted, vaginal electrical stimulation device (Ring) and other patient accessories.
Intervention: FemPulse System (Device)
Outcomes
Primary Outcomes
Patient Usability of System
Time Frame: 2 days
A survery will be conducted to determine the overall usability of the system
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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