Usability Study of the FemPulse System

FemPulse

Status: Completed

Conditions: Overactive Bladder

Treatments: Device: FemPulse System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06347380

CIP011

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Subjects receiving FemPulse System

Experimental group

Description:

Subjects will receive the Ring for the treatment of their OAB symptoms

Treatment:

Device: FemPulse System