Testing the FemPulse System for Overactive Bladder
Usability Study of the FemPulse System
This study is testing if the FemPulse System can help women with overactive bladder symptoms by seeing how well they can use the device.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 21 Years and up |
| Sex | Female |
| Sponsor | FemPulse Corporation Industry-sponsored |
| Locations | 2 sites (Fort Lauderdale, Florida and 1 other locations) |
| Trial ID | NCT06347380 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the usability of the FemPulse System, a neuromodulation device designed for treating overactive bladder (OAB) symptoms. Participants will be females aged 21 and older who have been diagnosed with OAB for at least six months. The study will assess whether the FemPulse System can be effectively used according to its Instructions for Use. Participants will be required to maintain consistent medication use and complete diaries related to their symptoms and device usage.
Who should consider this trial
Good fit: Ideal candidates are females aged 21 and older with a physician-confirmed diagnosis of overactive bladder lasting more than six months.
Not a fit: Patients who are currently pregnant, have been pregnant in the past year, or plan to change their OAB therapy during the study will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, effective treatment option for women suffering from overactive bladder.
How similar studies have performed: While this study focuses on the FemPulse System, similar neuromodulation approaches have shown promise in treating overactive bladder in previous studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Fort Lauderdale, Florida and 1 other locations
- Holy Cross Women's Hospital — Fort Lauderdale, Florida, United States (Recruiting)
- Univ. of Washington — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Roshini Jain
- Email: rjain@fempulse.com
- Phone: 4697669888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.