Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-09-11
2025-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Subjects receiving FemPulse System
Subjects will receive the Ring for the treatment of their OAB symptoms
FemPulse System
Subjects to receive the FemPulse System consisting of a non-implanted, vaginal electrical stimulation device (Ring) and other patient accessories.
Interventions
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FemPulse System
Subjects to receive the FemPulse System consisting of a non-implanted, vaginal electrical stimulation device (Ring) and other patient accessories.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
21 Years
FEMALE
No
Sponsors
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FemPulse Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Roshini Jain
Role: STUDY_DIRECTOR
Sponsor GmbH
Locations
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Holy Cross Women's Hospital
Fort Lauderdale, Florida, United States
Univ. of Washington
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CIP011
Identifier Type: -
Identifier Source: org_study_id
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