Usability Study of the FemPulse System

Description

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.

Conditions

Overactive Bladder

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Study Overview

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Study Details

Study overview

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.

Usability Study of the FemPulse System

Usability Study of the FemPulse System

Condition
Overactive Bladder
Intervention / Treatment

-

Contacts and Locations

Fort Lauderdale

Holy Cross Women's Hospital, Fort Lauderdale, Florida, United States, 33334

Seattle

Univ. of Washington, Seattle, Washington, United States, 98133

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

FemPulse Corporation,

Roshini Jain, STUDY_DIRECTOR, Sponsor GmbH

Study Record Dates

2024-12-30