Overactive Bladder (OAB)
Conditions
Keywords
neuromodulation
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.
Interventions
DEVICEFemPulse System
Subjects to receive the FemPulse System consisting of a non-implanted, vaginal electrical stimulation device (Ring) and other patient accessories.
Sponsors
FemPulse Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Usability of System | 2 days | A survery will be conducted to determine the overall usability of the system |
Countries
United States
Contacts
STUDY_DIRECTORRoshini Jain
FemPulse Corporation
Outcome results
None listed