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Trial record 53 of 272 for:    Recruiting, Not yet recruiting, Available Studies | "Lower Urinary Tract Symptoms"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04001426
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : June 28, 2019
Information provided by (Responsible Party):
FemPulse Corporation

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

Condition or disease Intervention/treatment Phase
Urinary Bladder, Overactive Device: The FemPulse System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Subjects will wear a device and will be monitored non-invasively during activation of the device.
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Pilot Phase for an Acute Evaluation of a Non-Implantable Electrical Continence Device
Actual Study Start Date : April 4, 2019
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Monitoring during activation of the FemPulse System
Subjects will undergo non-invasive monitoring during activation of the FemPulse System.
Device: The FemPulse System
Non-invasive monitoring during activation of the FemPulse System

Primary Outcome Measures :
  1. 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

  2. Evoked Potential response [ Time Frame: Up to 6 hours ]
    Surface electrodes will be used to detect whether evoked potentials are generated during device activation

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04001426

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Contact: Robert Kieval

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United States, Minnesota
Hennepin Healthcare Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Cherie Martinson    612-873-2607   
Principal Investigator: Adam Loavenbruck, MD         
Sub-Investigator: William Madland, MD         
Sponsors and Collaborators
FemPulse Corporation

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Responsible Party: FemPulse Corporation Identifier: NCT04001426     History of Changes
Other Study ID Numbers: CIP-003
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by FemPulse Corporation:
Overactive Bladder
Bioelectronic Medicine

Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms