Ease of Use Study of the FemPulse System

NCT ID: NCT06885099

Last Updated: 2025-03-20

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

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-11

Study Completion Date

2025-08-31

Brief Summary

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The objective of the study is to demonstrate that the FemPulse System can be used as indicated

Detailed Description

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The objective of the study is to demonstrate that the FemPulse System can be used as indicated in the Patient and Clinician Instructions for Use (IFU), as applicable.

Conditions

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Overactive Bladder (OAB)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Subjects receiving the FemPulse System

Subjects to receive the FemPulse System consisting of a non-implanted, vaginal electrical stimulation device (Ring) and other patient accessories.

Group Type EXPERIMENTAL

FemPulse System

Intervention Type DEVICE

Subjects to receive the FemPulse System consisting of a non-implanted, vaginal electrical stimulation device (Ring) and other patient accessories.

Interventions

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FemPulse System

Subjects to receive the FemPulse System consisting of a non-implanted, vaginal electrical stimulation device (Ring) and other patient accessories.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Females, defined as a person with a cervix, ≥21 years old, with OAB symptoms, 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 .
2. Able to read, comprehend, and reliably provide informed consent and study-related information.
3. Willing and able to comply with study required procedures and visits

Exclusion Criteria

1. Any significant pain, neurologic, psychological condition or other factors, that in the investigator's judgment, might confound the protocol study assessments, and adherence to the protocol.
2. Has a metal pelvic implant or an active implantable medical device, including but not limited to a cardiac pacemaker, cardioverter-defibrillator or neurostimulator 3 History of a cardiac condition including, but not limited to, clinically significant abnormal ECG or arrhythmia that may interfere with study participation as determined by investigator.

4\. Systemic condition or disease that may interfere with study participation or not an appropriate study candidate, as determined by study investigator.
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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FemPulse Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roshini Jain

Role: STUDY_DIRECTOR

FemPulse Corporation

Locations

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Holy Cross Women's Hospital

Fort Lauderdale, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Roshini Study Director

Role: CONTACT

469-766-9888

Peter Fredericks

Role: CONTACT

Facility Contacts

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Isha Khan

Role: primary

Other Identifiers

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CIP013

Identifier Type: -

Identifier Source: org_study_id

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