CompletedNCT06347380Updated Feb 6, 2026

Usability Study of the FemPulse System

An interventional study of FemPulse System in Overactive Bladder, sponsored by FemPulse Corporation. Completed at 2 sites in United States. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-02-06.

Sponsored by FemPulse Corporation · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 5
Allocation: Not applicable
Ages: 21 Years and older
Sex: Female

Study 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.

Conditions studied

Overactive Bladder

Browse trials for

Urinary Bladder, Overactive 854

Keywords

neuromodulation

Who can participate

Ages eligible: 21 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No

Eligibility 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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 5 participants (actual)

Study arms

Experimental
Subjects receiving FemPulse System
Subjects will receive the Ring for the treatment of their OAB symptoms
Device: FemPulse System

Interventions

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

What researchers measure

Primary outcomes

Patient Satisfaction
Proportion of subjects reporting satisfaction with the use of the FemPulse System
Time frame: 28 days

Study locations

2 sites

Holy Cross Women's Hospital
Fort Lauderdale, Florida 33334, United States
Univ. of Washington
Seattle, Washington 98133, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT06347380
Lead sponsor: FemPulse Corporation
Responsible party: Sponsor
First posted: Apr 4, 2024
Start date: Sep 11, 2024
Primary completion: Jul 31, 2025
Completion: Jul 31, 2025
Last update: Feb 6, 2026

Study contacts

Roshini Jain

study director · Sponsor GmbH

Oversight

FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Urinary Bladder, Overactive→

Other studies from this sponsor

FemPulse Corporation

Start the discussion