Overactive Bladder (OAB)EVANESCE-IINCT07195656
Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)
A study testing Device Group and Medication Group in people with Overactive Bladder (OAB), run by FemPulse Corporation at 15 sites in United States.
Trial summary
A study to evaluate the safety and effectiveness of FemPulse System Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Overactive Bladder (OAB)
- What is being tested?
- Device Group and Medication Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 15 sitesUnited States
- Study dates
- 30 Sep 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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. OAB is defined by urinary urgency, usually with urinary frequency and nocturia, with or without urgency urinary incontinence with symptoms
- Willing and able to comply with study required procedures and visits (e.g., maintaining consistent medication use, fluid intake, diary completion).
Who cannot join
- Systemic condition or disease that may interfere with study participation (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction, etc.) as determined by study investigator.
- Not an appropriate study candidate as determined by investigator.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
United States15 sites, 15 recruiting
- Recruiting
Comprehensive Urologic
Barrington, Illinois, 60010
Sunny Sian, 847-852-1777
Tamra Lewis, MD
- Recruiting
Cedars Sinai
Beverly Hills, California, 90211
Arman Jordan, 310-248-6716, arman.jordan@cshs.org
Karyn Eilber, MD
- Recruiting
Atrium Health
Charlotte, North Carolina, 28204
Robbin Clark, 704-355-7466
Michael Kennelly, MD
- Not yet recruiting
INOVA
Falls Church, Virginia, 22042
Claudia Lovo-Alvarez, 703-776-4600
Abbas Shobeiri, MD
- Recruiting
Holy Cross Medical Group - Women's Center
Fort Lauderdale, Florida, 33334
Judie Corbett, 954-542-4841
Guillermo Davila, MD
- Recruiting
UCLA
Los Angeles, California, 90095
Katie Levitt, (310) 794 - 6786, KLevitt@mednet.ucla.edu
A Lenore Ackerman, MD
- Not yet recruiting
University of Louisville
Louisville, Kentucky, 40205
Karissa Standiford, karissa.standiford@louisville.edu
Sean Francis, MD
- Recruiting
Adult & Pediatric Urology
Omaha, Nebraska, 68114
Peyton Schneider, 402-399-7898
Rebecca McCrery, MD
- Recruiting
UC Irvine
Orange, California, 92868
Bryan Robles, 714-509-6130
Olivia Chang, MD
- Recruiting
Chesapeake Urology
Owings Mills, Maryland, 21117
Seema Shahi, 410-616-8431
Laura Giusto, MD
- Recruiting
Stanford
Palo Alto, California, 94304
Kathryn Batham, 650-724-7826
Eric Sokol, MD
- Recruiting
USCD
San Diego, California, 92037
Melissa Saurez, 858-249-4447
Yahir Santiago-Lastra, MD
- Recruiting
Sanford Health
Sioux Falls, South Dakota, 57105
Jennifer Pratt, 605-328-1391
Kevin Benson, MD
- Recruiting
Southern Urogynecology
West Columbia, South Carolina, 29169
Tina McCready, 803-457-7000
Andrea Pezzella, MD
- Not yet recruiting
Minnesota Urology
Woodbury, Minnesota, 55125
Carrie McKenzie, 651-999-6903
Jodi Michaels, MD
About this study
Official title: Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB) EVANESCE-II
A study to evaluate the safety and effectiveness of FemPulse System
- Conditions
- Overactive Bladder (OAB)
- Being tested
- Device Group, Medication Group
- 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.
Device GroupDevice
non-implanted, vaginal electrical stimulation device
Medication GroupDrug
OAB Medication
| Study group | Role | What they receive |
|---|---|---|
| Device Group | Experimental | Subjects receiving the FemPulse System Receives: Device: Device Group |
| Medication Group | Other | Subjects receiving medication Receives: Drug: Medication Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Voids per Day
Difference in mean change between device and medication groups in number of voids per day (VPD)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start30 Sep 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder (OAB)Studies 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
- Masking
- None (open label)
- Enrolment
- 151 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FemPulse Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Moxie Clinical
- Responsible party
- Sponsor
- Investigators
- Suzette Sutherland, MD, Principal investigator, FemPulse Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195656
- Sponsor's protocol ID
- CIP012
- Acronym
- EVANESCE-II
- Status last verified
- Sep 2025
- First submitted
- 24 Sep 2025
- Last updated
- 13 Jul 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 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB) EVANESCE-II
- ClinicalTrials.gov ID
- NCT07195656
- Acronym / sponsor ID
- EVANESCE-II / CIP012
- Conditions
- Overactive Bladder (OAB)
- Keywords
- neuromodulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 151 participants (estimated)
- Lead sponsor
- FemPulse CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Moxie Clinical
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Sep 2025 (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.
A study to evaluate the safety and effectiveness of FemPulse System
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device Group | Experimental | Device: Device GroupSubjects receiving the FemPulse System |
| Medication Group | Other | Drug: Medication GroupSubjects receiving medication |
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, 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. OAB is defined by urinary urgency, usually with urinary frequency and nocturia, with or without urgency urinary incontinence with symptoms
- Willing and able to comply with study required procedures and visits (e.g., maintaining consistent medication use, fluid intake, diary completion).
Key exclusion criteria (2 listed)
- Systemic condition or disease that may interfere with study participation (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction, etc.) as determined by study investigator.
- 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 |
|---|---|---|
| Device Groupnon-implanted, vaginal electrical stimulation device | Device | Device Group |
| Medication GroupOAB Medication | Drug | Medication Group |
Primary outcome
Mean Change in Voids per Day
Time frame: 6 months
Difference in mean change between device and medication groups in number of voids per day (VPD)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Overactive Bladder (OAB)
Not yet recruiting
Parasacral TENS Project
Overactive Bladder (OAB), Lower Urinary Tract Dysfunction
RecruitingPhase 2
RELIEVE Study: NT 201 Intravesical Administration Using Vibe System (ViXe Combination Product) for the Treatment of Idiopathic Overactive Bladder
Overactive Bladder (OAB)
Recruiting
PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB
Urinary Urge Incontinence (UUI), Urinary Frequency (UF)
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
Aquarius Pilot Study to Evaluate the New Axonics Trial System
Urinary Urge Incontinence (UUI), Urinary Frequency (UF)
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.
Suzette Sutherland, MD principal investigator
FemPulse Corporation
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device Group and Medication Group in people with Overactive Bladder (OAB), run by FemPulse Corporation at 15 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 2 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: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monica Unger (7275123718, monica.unger@moxieclinical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Voids per Day (time frame: 6 months). 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 13 Jul 2026.