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Completed

NCT Number: NCT03784170

FemPulse Therapy for Overactive Bladder in Women

The purpose of this clinical trial is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.

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Key information

Conditions

Urinary Bladder, Overactive Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Minnesota Urology, Woodbury, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Females 21 years or older with a diagnosis of Overactive Bladder
  • If of reproductive age, must use a reliable form of contraception

Exclusion criteria

  • 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

Treatment and study plan

FemPulse System

Device

Device therapy with the FemPulse System

Primary outcomes

  1. All device- and procedure-related adverse events will be collected and tabulated

    Time frame: Approximately 11 days in total

    Adverse events

  2. Urinary frequency

    Time frame: Approximately 11 days in total

    Frequency of and intervals between urinary voids (voids per day and time between voids)

  3. Urinary urgency

    Time frame: Approximately 11 days in total

    Presence or absence of urgency with each void

  4. Urge urinary incontinence (UUI)

    Time frame: Approximately 11 days in total

    Presence or absence of UUI with each void

  5. OAB-q - Short Form

    Time frame: Approximately 11 days in total

    OAB bother quality of life questionnaire

  6. OAB Symptom Score

    Time frame: Approximately 11 days in total

    OAB symptoms quality of life questionnaire

  7. Urogenital Distress Inventory - Short Form

    Time frame: Approximately 11 days in total

    OAB-related distress quality of life questionnaire

  8. Incontinence Impact Questionnaire - Short Form

    Time frame: Approximately 11 days in total

    Impact of OAB quality of life questionnaire

Sponsors and collaborators

Lead sponsor

FemPulse Corporation

Industry

Registry information

Official study title

Evaluation of a Non-Implanted Electrical Stimulation Continence Device for Overactive Bladder

Acronym: EVANESCE-OAB

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 21, 2018
Registry last updated
Feb 6, 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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