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Recruiting

NCT Number: NCT07195656

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

A study to evaluate the safety and effectiveness of FemPulse System

Recruiting

Interested in participating?

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Key information

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cedars Sinai, Beverly Hills, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Device Group

Device

non-implanted, vaginal electrical stimulation device

Medication Group

Drug

OAB Medication

Primary outcomes

  1. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Monica Unger

CONTACT

[email protected]

7275123718

Sponsors and collaborators

Lead sponsor

FemPulse Corporation

Industry

Collaborators

  • Moxie Clinical

Registry information

Official study title

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

Acronym: EVANESCE-II

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 29, 2025
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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