Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB) (EVANESCE-II)

FemPulse

Status: Enrolling

Conditions: Overactive Bladder (OAB)

Treatments: Drug: Medication Group; Device: Device Group

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07195656

CIP012

Details and patient eligibility

About

A study to evaluate the safety and effectiveness of FemPulse System

Enrollment: 151 estimated patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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).

Key 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

151 participants in 2 patient groups

Device Group

Experimental group

Description:

Subjects receiving the FemPulse System

Treatment:

Device: Device Group

Medication Group

Other group

Description:

Subjects receiving medication

Treatment:

Drug: Medication Group