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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2028-05-31

Brief Summary

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A study to evaluate the safety and effectiveness of FemPulse System

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TERMINATED PHASE3

Detailed Description

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Conditions

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Overactive Bladder (OAB)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Device Group

Subjects receiving the FemPulse System

Group Type EXPERIMENTAL

Device Group

Intervention Type DEVICE

non-implanted, vaginal electrical stimulation device

Medication Group

Subjects receiving medication

Group Type OTHER

Medication Group

Intervention Type DRUG

OAB Medication

Interventions

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Device Group

non-implanted, vaginal electrical stimulation device

Intervention Type DEVICE

Medication Group

OAB Medication

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No