Urinary Bladder, OveractiveNCT03874637
FemPulse Therapy First-in-Human Experience
A study testing Treament in people with Urinary Bladder, Overactive, run by FemPulse Corporation at 2 sites in United States.
Trial summary
The purpose of this clinical trial 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 only
- Conditions the study is for
- Urinary Bladder, Overactive
- What is being tested?
- Treament
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Feb 2017to 17 May 2017
- 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 ≥21 yrs with Overactive Bladder
Who cannot join
- Is or was recently pregnant
- Has a metal pelvic implant or any electrically active implanted medical device
- Has a urinary tract or vaginal infection
- Had a previous hysterectomy, pelvic radiation or pelvic cancer
- Has significant pelvic organ prolapse
- Had bladder treatment with onabotulinumtoxinA in the previous 12 months or Tibial Nerve stimulation within the previous 30 days
- Has a significant heart condition or a history of vasovagal reaction or low blood pressure
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Washington Medical Center
Seattle, Washington, 98195
Minnesota Urology
Woodbury, Minnesota, 55125
About this study
Official title: Evaluation of a Wearable Electrical Incontinence Device in Subjects: A Non-significant Risk Clinical Evaluation of FemPulse Therapy in Women With OAB
The purpose of this clinical trial 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 in the lower abdomen 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
- Treament, Sham Control
- Keywords
- Overactive Bladder, Women, Neuromodulation, Bioelectronic Medicine, Non-significant Risk
- 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.
TreamentDevice
Placement of the FemPulse System with therapy delivery
Sham ControlDevice
Placement of the FemPulse System without therapy delivery
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Active therapy Receives: Device: Treament |
| Sham Control | Sham comparator | Sham Control Receives: Device: Sham Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
All device- and procedure-related adverse events will be collected and tabulated
Measured: 3 days in total
Placeability and comfort of the device
Subjects will be observed for their ability to place, orient and wear the device without discomfort. The outcome is Pass or Fail as determined by the investigator.
Measured: 3 days in total
Secondary outcomes (3)
Frequency of urinary voids
The number of voids per day will be tabulated
Measured: 3 days in total
Intervals between urinary voids
The time between voids (hours:minutes) will be tabulated
Measured: 3 days in total
Urge urinary incontinence (UUI)
Presence or absence of UUI with each void
Measured: 3 days in total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start14 Feb 2017
- Primary completion17 May 2017
- Study completion17 May 2017
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects will be treated at 2 different device settings (one of which is Off) in random sequence during two 6-hour periods at least one week apart.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 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
- NCT03874637
- Sponsor's protocol ID
- CIP-001
- Status last verified
- Feb 2019
- First submitted
- 4 Mar 2019
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- 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 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Wearable Electrical Incontinence Device in Subjects: A Non-significant Risk Clinical Evaluation of FemPulse Therapy in Women With OAB
- ClinicalTrials.gov ID
- NCT03874637
- Acronym / sponsor ID
- CIP-001
- Conditions
- Urinary Bladder, Overactive
- Keywords
- Overactive Bladder, Women, Neuromodulation, Bioelectronic Medicine, Non-significant Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- FemPulse CorporationIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 17 May 2017 (actual)
- Study completion
- 17 May 2017 (actual)
- First posted
- 14 Mar 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 clinical trial 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 in the lower abdomen that regulate bladder function. It is believed that stimulation of these nerves may help relieve the symptoms of OAB.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be treated at 2 different device settings (one of which is Off) in random sequence during two 6-hour periods at least one week apart.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: TreamentActive therapy |
| Sham Control | Sham comparator | Device: Sham ControlSham Control |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Females ≥21 yrs with Overactive Bladder
Key exclusion criteria (7 listed)
- Is or was recently pregnant
- Has a metal pelvic implant or any electrically active implanted medical device
- Has a urinary tract or vaginal infection
- Had a previous hysterectomy, pelvic radiation or pelvic cancer
- Has significant pelvic organ prolapse
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 |
|---|---|---|
| TreamentPlacement of the FemPulse System with therapy delivery | Device | Treatment |
| Sham ControlPlacement of the FemPulse System without therapy delivery | Device | Sham Control |
Primary outcome
Adverse Events
Time frame: 3 days in total
All device- and procedure-related adverse events will be collected and tabulated
Placeability and comfort of the device
Time frame: 3 days in total
Subjects will be observed for their ability to place, orient and wear the device without discomfort. The outcome is Pass or Fail as determined by the investigator.
3 secondary outcomes
Frequency of urinary voids
Time frame: 3 days in total
Intervals between urinary voids
Time frame: 3 days in total
Urge urinary incontinence (UUI)
Time frame: 3 days in total
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 14 Mar 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treament in people with Urinary Bladder, Overactive, 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 1 inclusion and 7 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 14 Mar 2019. 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. Some participants in this study may receive a placebo. 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?
Adverse Events (time frame: 3 days in total). 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 14 Mar 2019; AzTrials last refreshed its copy on 27 Oct 2026.