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

The purpose of this feasibility clinical investigation 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

Hennepin Healthcare

Minneapolis, Minnesota, 55404, United States

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: Yes

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

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

Treatment and study plan

The FemPulse System

Device

Non-invasive monitoring during activation of the FemPulse System

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

FemPulse Corporation

Industry

Registry information

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Jun 28, 2019
Registry last updated: Nov 4, 2021

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.

Published trials that share one or more normalized conditions with this study.

Completed