Back to search results

Study of FemPulse System for Overactive Bladder (OAB)

This study is looking at a new, non-implanted electrical stimulation device called the FemPulse System for women with Overactive Bladder (OAB). OAB is when you have a sudden, strong need to urinate, often with frequent urination and waking up at night to urinate. Researchers want to see how well the FemPulse System works compared to standard OAB medication. They will measure changes in how many times a day participants urinate over 6 months. Women aged 21 and older with a uterus and cervix, who have had OAB symptoms for over 6 months, may be able to join. The current status of this study is unclear.

Study design
This interventional study plans to enroll 151 participants. It compares a device group using the FemPulse System to a medication group receiving OAB medication.
What's involved
You would need to be willing and able to follow all study procedures and attend required visits.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 6 months, suggesting follow-up for at least this duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07195656

Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)

Recruiting
NAAges 21+InterventionalTreatment
FemPulse Corporation
~151 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:Device GroupMedication Group

At a glance

Recruiting sites
12 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean Change in Voids per Day
Measured over 6 months

Conditions

Overactive Bladder (OAB)

Explore related trials

Overactive Bladder

Where it's being run

15 sites across 11 states
California5
Florida1
Illinois1
Kentucky1
Maryland1
Minnesota1
Nebraska1
North Carolina1

Study leadership

  • Suzette Sutherland, MD · PRINCIPAL_INVESTIGATOR · FemPulse Corporation

Who to contact

Monica Unger
[email protected]
7275123718
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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. OAB is defined by urinary urgency, usually with urinary frequency and nocturia, with or without urgency urinary incontinence with symptoms
Willing and able to comply with study required procedures and visits (e.g., maintaining consistent medication use, fluid intake, diary completion).

Exclusion

Systemic condition or disease that may interfere with study participation (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction, etc.) as determined by study investigator.
Not an appropriate study candidate as determined by investigator.

What this trial measures

  • Mean Change in Voids per Day6 months

    Difference in mean change between device and medication groups in number of voids per day (VPD)