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OpenTrials
Completed

NCT Number: NCT06347380

Usability Study of the FemPulse System

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.

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Holy Cross Women's Hospital, Fort Lauderdale, Florida, United States

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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 uterus and cervix, ≥21 years old, with a diagnosis 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-related information.
  • 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 and other components (e.g., mobile app) as assessed by the investigator.

Key Exclusion Criteria:

  • Currently pregnant, was pregnant in the past 12 months or intending to conceive during the study period.
  • Plans to begin other OAB therapies or otherwise change their existing therapy regimen during the study period.
  • Not an appropriate study candidate as determined by 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 Satisfaction

    Time frame: 28 days

    Proportion of subjects reporting satisfaction with the use of the FemPulse System

Sponsors and collaborators

Lead sponsor

FemPulse Corporation

Industry

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2024
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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