Pilot Phase for an Acute Evaluation of a Non-Implantable Electrical Continence Device

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Device Feasibility
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2019

Detailed Description

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.

Interventions

  • Device: The FemPulse System
    • Non-invasive monitoring during activation of the FemPulse System

Arms, Groups and Cohorts

  • Experimental: Monitoring during activation of the FemPulse System
    • Subjects will undergo non-invasive monitoring during activation of the FemPulse System.

Clinical Trial Outcome Measures

Primary Measures

  • Autonomic nervous system response
    • Time Frame: Up to 6 hours
    • The Quantitative Sudomotor Axon Reflex Test (QSART) will be used to detect changes in autonomic nervous system activity during device activation
  • Evoked Potential response
    • Time Frame: Up to 6 hours
    • Surface electrodes will be used to detect whether evoked potentials are generated during device activation

Participating in This Clinical Trial

Inclusion Criteria

  • Normal healthy women ≥ 21 years old – Using contraception if of reproductive age Exclusion Criteria:

  • Pregnant, recently pregnant or actively trying to conceive – Prior hysterectomy – Current or recent urinary tract or vaginal infection

Gender Eligibility: Female

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • FemPulse Corporation
  • Provider of Information About this Clinical Study
    • Sponsor

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