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OpenTrials
Completed

NCT Number: NCT06885099

Ease of Use Study of the FemPulse System

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

FemPulse System

Device

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

Primary outcomes

  1. Patient Usability of System

    Time frame: 2 days

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

Sponsors and collaborators

Lead sponsor

FemPulse Corporation

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2025
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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