Usability Study of the FemPulse System

Last updated: February 11, 2025
Sponsor: FemPulse Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Enuresis

Overactive Bladder

Treatment

FemPulse System

Clinical Study ID

NCT06347380
CIP011
  • Ages > 21
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Females, defined as a person with a uterus and cervix, ≥21 years old, with adiagnosis of OAB and symptoms for more than 6 months, as confirmed by a physician

  • Able to read, comprehend, and reliably provide informed consent and study-relatedinformation.

  • Willing and able to comply with study required procedures and visits (e.g.,maintaining consistent medication use, fluid intake, diary completion).

  • Has adequate cognitive and manual capabilities to operate the FemPulse System andother components (e.g., mobile app) as assessed by the investigator.

Exclusion

Key Exclusion Criteria:

  • Currently pregnant, was pregnant in the past 12 months or intending to conceiveduring the study period.

  • Plans to begin other OAB therapies or otherwise change their existing therapyregimen during the study period.

  • Not an appropriate study candidate as determined by investigator.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: FemPulse System
Phase:
Study Start date:
September 11, 2024
Estimated Completion Date:
December 30, 2025

Connect with a study center

  • Holy Cross Women's Hospital

    Fort Lauderdale, Florida 33334
    United States

    Active - Recruiting

  • Univ. of Washington

    Seattle, Washington 98133
    United States

    Active - Recruiting

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