FemPulse Therapy for Overactive Bladder in Women
- Conditions
- Urinary Bladder, Overactive
- Interventions
- Device: FemPulse System
- Registration Number
- NCT03784170
- Lead Sponsor
- FemPulse Corporation
- Brief Summary
The purpose of this clinical trial is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.
- Detailed Description
The FemPulse System is a vaginal ring intended to provide mild electrical stimulation to nerves that regulate bladder function. It is believed that stimulation of these nerves may help relieve the symptoms of OAB.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 21
- Females 21 years or older with a diagnosis of Overactive Bladder
- If of reproductive age, must use a reliable form of contraception
- Pregnant, was recently pregnant or is trying to conceive
- Has a metal pelvic implant or any electrically active implanted medical device
- Had a previous hysterectomy, pelvic radiation or pelvic cancer
- Has significant pelvic organ prolapse
- Had bladder treatment with onabotulinumtoxinA in the previous 12 months
- Has a significant heart condition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment FemPulse System FemPulse System at one device setting Control FemPulse System FemPulse System at a different device setting
- Primary Outcome Measures
Name Time Method All device- and procedure-related adverse events will be collected and tabulated Approximately 11 days in total Adverse events
OAB-q - Short Form Approximately 11 days in total OAB bother quality of life questionnaire
Urinary frequency Approximately 11 days in total Frequency of and intervals between urinary voids (voids per day and time between voids)
OAB Symptom Score Approximately 11 days in total OAB symptoms quality of life questionnaire
Urinary urgency Approximately 11 days in total Presence or absence of urgency with each void
Urge urinary incontinence (UUI) Approximately 11 days in total Presence or absence of UUI with each void
Urogenital Distress Inventory - Short Form Approximately 11 days in total OAB-related distress quality of life questionnaire
Incontinence Impact Questionnaire - Short Form Approximately 11 days in total Impact of OAB quality of life questionnaire
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Minnesota Urology
🇺🇸Woodbury, Minnesota, United States
McKay Urology
🇺🇸Charlotte, North Carolina, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States