Using the FemPulse System for Overactive Bladder
Ease of Use Study of the FemPulse System
NA · FemPulse Corporation · NCT06885099
This study is testing the FemPulse System to see if it can help women with overactive bladder symptoms feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 21 Years and up |
| Sex | Female |
| Sponsor | FemPulse Corporation (industry) |
| Locations | 1 site (Fort Lauderdale, Florida) |
| Trial ID | NCT06885099 on ClinicalTrials.gov |
What this trial studies
This study aims to demonstrate the usability of the FemPulse System for treating Overactive Bladder (OAB) symptoms in women. Participants will be females aged 21 and older who have been diagnosed with OAB by a physician. The study will assess the system's effectiveness based on the provided Patient and Clinician Instructions for Use. Participants will need to comply with study procedures and visits to ensure accurate results.
Who should consider this trial
Good fit: Ideal candidates are females aged 21 and older with confirmed symptoms of Overactive Bladder.
Not a fit: Patients with significant pain, neurological or psychological conditions, or those with certain medical implants may not benefit from this study.
Why it matters
Potential benefit: If successful, this could provide a new, effective treatment option for women suffering from Overactive Bladder.
How similar studies have performed: Other studies have explored neuromodulation for OAB, showing promising results, but the FemPulse System's specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Fort Lauderdale, Florida
- Holy Cross Women's Hospital — Fort Lauderdale, Florida, United States (RECRUITING)
Study contacts
- Study coordinator: Roshini Study Director
- Email: rjain@fempulse.com
- Phone: 469-766-9888
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.
Conditions: Overactive Bladder, neuromodulation