Recruiting NCT07195656
Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Device Group, Medication Group.
- Who it may be relevant to
- Registry conditions: Overactive Bladder (OAB). Basic parameters: from 21 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB) EVANESCE-II
Overview
A study to evaluate the safety and effectiveness of FemPulse System
Interventions
- Device Device Group
non-implanted, vaginal electrical stimulation device - Drug Medication Group
OAB Medication
Primary outcome measures
- Mean Change in Voids per Day [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 15 centers
- Cedars Sinai — Beverly Hills
- UCLA — Los Angeles
- UC Irvine — Orange
- Stanford — Palo Alto
- USCD — San Diego
- Holy Cross Medical Group - Women's Center — Fort Lauderdale
- Comprehensive Urologic — Barrington
- University of Louisville — Louisville
- … and 7 more centers
Identifiers
NCT: NCT07195656 · CIP012