FemPulse Therapy First-in-Human Experience

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 in the lower abdomen 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 Wearable Electrical Incontinence Device in Subjects: A Non-significant Risk Clinical Evaluation of FemPulse Therapy in Women With OAB

Conditions
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Urinary Bladder, Overactive

Intervention / Treatment
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* Device: Treament
* Device: Sham Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females ≥21 yrs with Overactive Bladder Exclusion Criteria: Is or was recently pregnant Has a metal pelvic implant or any electrically active implanted medical device Has a urinary tract or vaginal infection Had a previous hysterectomy, pelvic radiation or pelvic cancer Has significant pelvic organ prolapse Had bladder treatment with onabotulinumtoxinA in the previous 12 months or Tibial Nerve stimulation within the previous 30 days Has a significant heart condition or a history of vasovagal reaction or low blood pressure

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Subjects will be treated at 2 different device settings (one of which is Off) in random sequence during two 6-hour periods at least one week apart.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Active therapy | Device: Treament<br>* Placement of the FemPulse System with therapy delivery<br>|
| Sham Comparator: Sham Control<br>Sham Control | Device: Sham Control<br>* Placement of the FemPulse System without therapy delivery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | All device- and procedure-related adverse events will be collected and tabulated | 3 days in total | 
| Placeability and comfort of the device | Subjects will be observed for their ability to place, orient and wear the device without discomfort. The outcome is Pass or Fail as determined by the investigator. | 3 days in total | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of urinary voids | The number of voids per day will be tabulated | 3 days in total | 
| Intervals between urinary voids | The time between voids (hours:minutes) will be tabulated | 3 days in total | 
| Urge urinary incontinence (UUI) | Presence or absence of UUI with each void | 3 days in total | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overactive Bladder, Women, Neuromodulation, Bioelectronic Medicine, Non-significant Risk