Overactive BladderNCT06347380
Usability Study of the FemPulse System
A study testing FemPulse System in people with Overactive Bladder, run by FemPulse Corporation at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- FemPulse System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Sep 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Holy Cross Women's Hospital
Fort Lauderdale, Florida, 33334
Univ. of Washington
Seattle, Washington, 98133
About this study
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
- Being tested
- FemPulse System
- Keywords
- neuromodulation
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FemPulse SystemDevice
Subjects to receive the FemPulse System consisting of a non-implanted, vaginal electrical stimulation device (Ring) and other patient accessories.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving FemPulse System | Experimental | Subjects will receive the Ring for the treatment of their OAB symptoms Receives: Device: FemPulse System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Proportion of subjects reporting satisfaction with the use of the FemPulse System
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start11 Sep 2024
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- FemPulse Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roshini Jain, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347380
- Sponsor's protocol ID
- CIP011
- Status last verified
- Feb 2025
- First submitted
- 29 Mar 2024
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability Study of the FemPulse System
- ClinicalTrials.gov ID
- NCT06347380
- Acronym / sponsor ID
- CIP011
- Conditions
- Overactive Bladder
- Keywords
- neuromodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- FemPulse CorporationIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving FemPulse System | Experimental | Device: FemPulse SystemSubjects will receive the Ring for the treatment of their OAB symptoms |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FemPulse SystemSubjects to receive the FemPulse System consisting of a non-implanted, vaginal electrical stimulation device (Ring) and other patient accessories. | Device | Subjects receiving FemPulse System |
Primary outcome
Patient Satisfaction
Time frame: 28 days
Proportion of subjects reporting satisfaction with the use of the FemPulse System
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roshini Jain study director
Sponsor GmbH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FemPulse System in people with Overactive Bladder, run by FemPulse Corporation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.