ClinicalTrials.gg
CompletedNCT06885099Updated Feb 6, 2026

Ease of Use Study of the FemPulse System

An interventional study of FemPulse System in Overactive Bladder (OAB), sponsored by FemPulse Corporation. Completed at 1 site 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

From the registry’s dates

  • Primary completion was Jul 2025, 1 year 3 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
21 Years and older
Sex
Female
01

Study summary

The objective of the study is to demonstrate that the FemPulse System can be used as indicated

Read the detailed description

The objective of the study is to demonstrate that the FemPulse System can be used as indicated in the Patient and Clinician Instructions for Use (IFU), as applicable.

02

Conditions studied

  • Overactive Bladder (OAB)

Keywords

  • neuromodulation
03

In context

Urinary Bladder, Overactive

858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.

This study's enrollment of 11 is below the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.

Browse Urinary Bladder, Overactive studies →

Lead sponsor

FemPulse Corporation is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Eligibility criteria

Key Inclusion Criteria:

  1. Females, defined as a person with a cervix, ≥21 years old, with OAB symptoms, as confirmed by a physician. OAB is defined by urinary urgency, usually with urinary frequency and nocturia, with or without urgency urinary incontinence with symptoms .
  2. Able to read, comprehend, and reliably provide and study-related information.
  3. Willing and able to comply with study required procedures and visits

Exclusion Criteria:

  1. Any significant pain, neurologic, psychological condition or other factors, that in the investigator's judgment, might confound the protocol study assessments, and adherence to the protocol.
  2. Has a metal pelvic implant or an active implantable medical device, including but not limited to a cardiac pacemaker, cardioverter-defibrillator or neurostimulator 3 History of a cardiac condition including, but not limited to, abnormal or arrhythmia that may interfere with study participation as determined by investigator.

4. Systemic condition or disease that may interfere with study participation or not an appropriate study candidate, as determined by study investigator.

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

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

Study arms

  • Experimental
    Subjects receiving the FemPulse System

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

    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.

06

What researchers measure

Primary outcomes

  1. Patient Usability of System

    A survery will be conducted to determine the overall usability of the system

    Time frame: 2 days

07

Study locations

1 site
  • Holy Cross Women's Hospital
    Fort Lauderdale, Florida 33334, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06885099
Lead sponsor
FemPulse Corporation
Responsible party
Sponsor
First posted
Mar 20, 2025
Start date
Feb 11, 2025
Primary completion
Jul 31, 2025
Completion
Jul 31, 2025
Last update
Feb 6, 2026

Study contacts

Roshini Jain
study director · FemPulse Corporation

Oversight

Data monitoring committee
No
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 Mar 2025. You cannot join it, but the record below documents what was studied.

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