Urinary Bladder, OveractiveEVANESCE-OABNCT03784170
FemPulse Therapy for Overactive Bladder in Women
A study testing FemPulse System in people with Urinary Bladder, Overactive, run by FemPulse Corporation at 3 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?
- FemPulse System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Dec 2018to 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females 21 years or older with a diagnosis of Overactive Bladder
- If of reproductive age, must use a reliable form of contraception
Who cannot join
- Pregnant, was recently pregnant or is trying to conceive
- Has a metal pelvic implant or any electrically active implanted medical device
- Had a previous hysterectomy, pelvic radiation or pelvic cancer
- Has significant pelvic organ prolapse
- Had bladder treatment with onabotulinumtoxinA in the previous 12 months
- Has a significant heart condition
Trial locations and contacts
3 sites in 1 country.
United States3 sites
McKay Urology
Charlotte, North Carolina, 28207
University of Washington Medical Center
Seattle, Washington, 98195
Minnesota Urology
Woodbury, Minnesota, 55125
About this study
Official title: Evaluation of a Non-Implanted Electrical Stimulation Continence Device for Overactive Bladder
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 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
- FemPulse System
- Keywords
- Overactive Bladder, OAB, 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.
FemPulse SystemDevice
Device therapy with the FemPulse System
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | FemPulse System at one device setting Receives: Device: FemPulse System |
| Control | Sham comparator | FemPulse System at a different device setting Receives: Device: FemPulse System |
What is being measured
The primary outcome is the main question the study is designed to answer.
All device- and procedure-related adverse events will be collected and tabulated
Adverse events
Measured: Approximately 11 days in total
Urinary frequency
Frequency of and intervals between urinary voids (voids per day and time between voids)
Measured: Approximately 11 days in total
Urinary urgency
Presence or absence of urgency with each void
Measured: Approximately 11 days in total
Urge urinary incontinence (UUI)
Presence or absence of UUI with each void
Measured: Approximately 11 days in total
OAB-q - Short Form
OAB bother quality of life questionnaire
Measured: Approximately 11 days in total
OAB Symptom Score
OAB symptoms quality of life questionnaire
Measured: Approximately 11 days in total
Urogenital Distress Inventory - Short Form
OAB-related distress quality of life questionnaire
Measured: Approximately 11 days in total
Incontinence Impact Questionnaire - Short Form
Impact of OAB quality of life questionnaire
Measured: Approximately 11 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 posted21 Dec 2018
- Study start11 Dec 2018
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will wear a device and will be treated at 1 of 2 device settings for approximately 3 days.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 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
- NCT03784170
- Sponsor's protocol ID
- CIP-002
- Acronym
- EVANESCE-OAB
- Status last verified
- Feb 2020
- First submitted
- 14 Dec 2018
- Last updated
- 6 Feb 2026
- 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 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Non-Implanted Electrical Stimulation Continence Device for Overactive Bladder
- ClinicalTrials.gov ID
- NCT03784170
- Acronym / sponsor ID
- EVANESCE-OAB / CIP-002
- Conditions
- Urinary Bladder, Overactive
- Keywords
- Overactive Bladder, OAB, Women, Neuromodulation, Bioelectronic Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- FemPulse CorporationIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 21 Dec 2018 (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 that regulate bladder function. It is believed that stimulation of these nerves may help relieve the symptoms of OAB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will wear a device and will be treated at 1 of 2 device settings for approximately 3 days.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: FemPulse SystemFemPulse System at one device setting |
| Control | Sham comparator | Device: FemPulse SystemFemPulse System at a different device setting |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Females 21 years or older with a diagnosis of Overactive Bladder
- If of reproductive age, must use a reliable form of contraception
Key exclusion criteria (6 listed)
- Pregnant, was recently pregnant or is trying to conceive
- Has a metal pelvic implant or any electrically active implanted medical device
- Had a previous hysterectomy, pelvic radiation or pelvic cancer
- Has significant pelvic organ prolapse
- Had bladder treatment with onabotulinumtoxinA in the previous 12 months
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 SystemDevice therapy with the FemPulse System | Device | Control, Treatment |
Primary outcome
All device- and procedure-related adverse events will be collected and tabulated
Time frame: Approximately 11 days in total
Adverse events
Urinary frequency
Time frame: Approximately 11 days in total
Frequency of and intervals between urinary voids (voids per day and time between voids)
Urinary urgency
Time frame: Approximately 11 days in total
Presence or absence of urgency with each void
Urge urinary incontinence (UUI)
Time frame: Approximately 11 days in total
Presence or absence of UUI with each void
OAB-q - Short Form
Time frame: Approximately 11 days in total
OAB bother quality of life questionnaire
OAB Symptom Score
Time frame: Approximately 11 days in total
OAB symptoms quality of life questionnaire
Urogenital Distress Inventory - Short Form
Time frame: Approximately 11 days in total
OAB-related distress quality of life questionnaire
Incontinence Impact Questionnaire - Short Form
Time frame: Approximately 11 days in total
Impact of OAB quality of life questionnaire
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.
The record lists no contact. Use the official record to reach the sponsor.
3 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 Urinary Bladder, Overactive, run by FemPulse Corporation at 3 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 2 inclusion and 6 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 3 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?
All device- and procedure-related adverse events will be collected and tabulated (time frame: Approximately 11 days in total). The study lists 8 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 6 Feb 2026.