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NCT06347380 Clinical Trial

Usability Study of the FemPulse System

Overactive Bladder Clinical Trial

Official title:
Usability Study of the FemPulse System

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06347380
Other study ID # CIP011
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date August 30, 2024

Study information
Verified date March 2024
Source FemPulse Corporation
Contact Roshini Jain
Phone 4697669888
Email rjain@fempulse.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date August 30, 2024
Est. primary completion date August 30, 2024
Accepts healthy volunteers No
Gender Female
Age group 21 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
FemPulse Corporation

Outcome
Type Measure Description Time frame Safety issue
Primary Patient Satisfaction Proportion of subjects reporting satisfaction with the use of the FemPulse System 28 days
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