FemPulse Therapy for Overactive Bladder in Women

Study Overview
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Brief Summary
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The purpose of this clinical trial is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.

Detailed Description
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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.

Official Title
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Evaluation of a Non-Implanted Electrical Stimulation Continence Device for Overactive Bladder

Conditions
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Urinary Bladder, Overactive

Intervention / Treatment
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* Device: FemPulse System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females 21 years or older with a diagnosis of Overactive Bladder If of reproductive age, must use a reliable form of contraception Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will wear a device and will be treated at 1 of 2 device settings for approximately 3 days.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>FemPulse System at one device setting | Device: FemPulse System<br>* Device therapy with the FemPulse System<br>|
| Sham Comparator: Control<br>FemPulse System at a different device setting | Device: FemPulse System<br>* Device therapy with the FemPulse System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All device- and procedure-related adverse events will be collected and tabulated | Adverse events | Approximately 11 days in total | 
| Urinary frequency | Frequency of and intervals between urinary voids (voids per day and time between voids) | Approximately 11 days in total | 
| Urinary urgency | Presence or absence of urgency with each void | Approximately 11 days in total | 
| Urge urinary incontinence (UUI) | Presence or absence of UUI with each void | Approximately 11 days in total | 
| OAB-q - Short Form | OAB bother quality of life questionnaire | Approximately 11 days in total | 
| OAB Symptom Score | OAB symptoms quality of life questionnaire | Approximately 11 days in total | 
| Urogenital Distress Inventory - Short Form | OAB-related distress quality of life questionnaire | Approximately 11 days in total | 
| Incontinence Impact Questionnaire - Short Form | Impact of OAB quality of life questionnaire | Approximately 11 days in total | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overactive Bladder, OAB, Women, Neuromodulation, Bioelectronic Medicine