Overactive Bladder
Conditions
Keywords
neuromodulation
Brief summary
The objective of the study is to demonstrate that the FemPulse System can be used as indicated in the 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: * Females, defined as a person with a uterus and cervix, ≥21 years old, with a diagnosis of OAB and symptoms for more than 6 months, as confirmed by a physician * Able to read, comprehend, and reliably provide informed consent and study-related information. * Willing and able to comply with study required procedures and visits (e.g., maintaining consistent medication use, fluid intake, diary completion). * Has adequate cognitive and manual capabilities to operate the FemPulse System and other components (e.g., mobile app) as assessed by the investigator. Key
Exclusion criteria
* Currently pregnant, was pregnant in the past 12 months or intending to conceive during the study period. * Plans to begin other OAB therapies or otherwise change their existing therapy regimen during the study period. * Not an appropriate study candidate as determined by investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 28 days | Proportion of subjects reporting satisfaction with the use of the FemPulse System |
Countries
United States
Contacts
STUDY_DIRECTORRoshini Jain
Sponsor GmbH
Outcome results
None listed