Ease of Use Study of the FemPulse System

NCT06885099 | Completed FDA Device

• 1 other identifier: CIP013
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Overactive Bladder (OAB)

Keywords

neuromodulation

Outcome Measures

Primary Outcomes (1)

• Patient Usability of System

  A survery will be conducted to determine the overall usability of the system

  2 days

Study Arms (1)

Subjects receiving the FemPulse System

EXPERIMENTAL

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

Device: FemPulse System

Interventions

FemPulse System DEVICE

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

Subjects receiving the FemPulse System

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: Females, defined as a person with a uterus and cervix.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .
• Able to read, comprehend, and reliably provide informed consent and study-related information.
• Willing and able to comply with study required procedures and visits

You may not qualify if:

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

Sponsors & Collaborators

• FemPulse Corporation: lead

Study Sites (1)

Holy Cross Women's Hospital

Fort Lauderdale, Florida, 33334, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Roshini Jain

  FemPulse Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: March 20, 2025
• Study Start: February 11, 2025
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: February 6, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)