FemPulse Therapy for Overactive Bladder in Women

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-11

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

FemPulse Therapy First-in-Human Experience

NCT03874637

Urinary Bladder, Overactive

COMPLETED NA

Pilot Phase for an Acute Evaluation of a Non-Implantable Electrical Continence Device

NCT04001426

Urinary Bladder, Overactive

COMPLETED NA

Usability Study of the FemPulse System

NCT06347380

Overactive Bladder

RECRUITING NA

Use of Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS) in Maintaining OAB Symptoms Improvement.

NCT02377765

Overactive Bladder

COMPLETED NA

At-Home Transcutaneous Tibial Nerve Stimulation for Overactive Bladder in Rural Women

NCT07178314

Overactive Bladder

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urinary Bladder, Overactive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects will wear a device and will be treated at 1 of 2 device settings for approximately 3 days.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment

FemPulse System at one device setting

Group Type EXPERIMENTAL

FemPulse System

Intervention Type DEVICE

Device therapy with the FemPulse System

Control

FemPulse System at a different device setting

Group Type SHAM_COMPARATOR

FemPulse System

Intervention Type DEVICE

Device therapy with the FemPulse System

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FemPulse System

Device therapy with the FemPulse System

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No