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Completed

NCT Number: NCT03874637

FemPulse Therapy First-in-Human Experience

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 in the lower abdomen 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 yrs with Overactive Bladder

Exclusion criteria

  • Is or was recently pregnant
  • Has a metal pelvic implant or any electrically active implanted medical device
  • Has a urinary tract or vaginal infection
  • Had a previous hysterectomy, pelvic radiation or pelvic cancer
  • Has significant pelvic organ prolapse
  • Had bladder treatment with onabotulinumtoxinA in the previous 12 months or Tibial Nerve stimulation within the previous 30 days
  • Has a significant heart condition or a history of vasovagal reaction or low blood pressure

Treatment and study plan

Treament

Device

Placement of the FemPulse System with therapy delivery

sham control

Device

Placement of the FemPulse System without therapy delivery

Primary outcomes

  1. Adverse Events

    Time frame: 3 days in total

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

  2. Placeability and comfort of the device

    Time frame: 3 days in total

    Subjects will be observed for their ability to place, orient and wear the device without discomfort. The outcome is Pass or Fail as determined by the investigator.

Secondary outcomes

  1. Frequency of urinary voids

    Time frame: 3 days in total

    The number of voids per day will be tabulated

  2. Intervals between urinary voids

    Time frame: 3 days in total

    The time between voids (hours:minutes) will be tabulated

  3. Urge urinary incontinence (UUI)

    Time frame: 3 days in total

    Presence or absence of UUI with each void

Sponsors and collaborators

Lead sponsor

FemPulse Corporation

Industry

Registry information

Official study title

Evaluation of a Wearable Electrical Incontinence Device in Subjects: A Non-significant Risk Clinical Evaluation of FemPulse Therapy in Women With OAB

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 14, 2019
Registry last updated
Mar 14, 2019

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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