Urinary Bladder, OveractiveNCT04001426
Pilot Phase for an Acute Evaluation of a Non-Implantable Electrical Continence Device
A study testing The FemPulse System in people with Urinary Bladder, Overactive, run by FemPulse Corporation at 1 site in United States.
Trial summary
The purpose of this feasibility clinical investigation is to investigate a new medical device treatment for Overactive Bladder (OAB) in women. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Bladder, Overactive
- What is being tested?
- The FemPulse System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2019to 31 Dec 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal healthy women ≥ 21 years old
- Using contraception if of reproductive age
Who cannot join
- Pregnant, recently pregnant or actively trying to conceive
- Prior hysterectomy
- Current or recent urinary tract or vaginal infection
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this feasibility clinical investigation is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.
Read the detailed description
The FemPulse System is a vaginal ring intended to provide mild electrical stimulation to nerves that regulate bladder function. It is believed that stimulation of these nerves may help relieve the symptoms of OAB.
- Conditions
- Urinary Bladder, Overactive
- Being tested
- The FemPulse System
- Keywords
- Overactive Bladder, Women, Neuromodulation, Bioelectronic Medicine
- 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.
The FemPulse SystemDevice
Non-invasive monitoring during activation of the FemPulse System
| Study group | Role | What they receive |
|---|---|---|
| Monitoring during activation of the FemPulse System | Experimental | Subjects will undergo non-invasive monitoring during activation of the FemPulse System. Receives: Device: The FemPulse System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autonomic nervous system response
The Quantitative Sudomotor Axon Reflex Test (QSART) will be used to detect changes in autonomic nervous system activity during device activation
Measured: Up to 6 hours
Evoked Potential response
Surface electrodes will be used to detect whether evoked potentials are generated during device activation
Measured: Up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start4 Apr 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder, OveractiveStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will wear a device and will be monitored non-invasively during activation of the device.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- FemPulse Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001426
- Sponsor's protocol ID
- CIP-003
- Status last verified
- Nov 2021
- First submitted
- 24 Jun 2019
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Phase for an Acute Evaluation of a Non-Implantable Electrical Continence Device
- ClinicalTrials.gov ID
- NCT04001426
- Acronym / sponsor ID
- CIP-003
- Conditions
- Urinary Bladder, Overactive
- Keywords
- Overactive Bladder, Women, Neuromodulation, Bioelectronic Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- FemPulse CorporationIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 28 Jun 2019 (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 purpose of this feasibility clinical investigation is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.
Detailed description
The FemPulse System is a vaginal ring intended to provide mild electrical stimulation to nerves that regulate bladder function. It is believed that stimulation of these nerves may help relieve the symptoms of OAB.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will wear a device and will be monitored non-invasively during activation of the device.
| Arm | Type | Receives |
|---|---|---|
| Monitoring during activation of the FemPulse System | Experimental | Device: The FemPulse SystemSubjects will undergo non-invasive monitoring during activation of the FemPulse System. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Normal healthy women ≥ 21 years old
- Using contraception if of reproductive age
Key exclusion criteria (3 listed)
- Pregnant, recently pregnant or actively trying to conceive
- Prior hysterectomy
- Current or recent urinary tract or vaginal infection
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 |
|---|---|---|
| The FemPulse SystemNon-invasive monitoring during activation of the FemPulse System | Device | Monitoring during activation of the FemPulse System |
Primary outcome
Autonomic nervous system response
Time frame: Up to 6 hours
The Quantitative Sudomotor Axon Reflex Test (QSART) will be used to detect changes in autonomic nervous system activity during device activation
Evoked Potential response
Time frame: Up to 6 hours
Surface electrodes will be used to detect whether evoked potentials are generated during device activation
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 4 Nov 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The FemPulse System in people with Urinary Bladder, Overactive, run by FemPulse Corporation at 1 site 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 2 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 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Autonomic nervous system response (time frame: Up to 6 hours). The study lists 2 primary outcomes in all. 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 4 Nov 2021.