Safety Demonstration of Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle

NCT ID: NCT03174470

Last Updated: 2019-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-02

Study Completion Date

2017-06-30

Brief Summary

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The company suggests a new concept of treatment for PE: Transient inhibition of striated muscle contraction by a transcutaneous stimulation device. This study aim is to evaluate the safety of delivering increasing electrical stimulation intensities to the subject's perineum, using a TENS technique and equipment, followed by a 72-hour postoperative follow-up.

Detailed Description

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Conditions

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Premature Ejaculation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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TENS stimulator

Single day Transcutaneous electrical nerve stimulations utilizing a commercial TENS stimulator (TensMed S82 ENRAF-NONIUS)

Group Type EXPERIMENTAL

TENS Stimulator

Intervention Type DEVICE

Initial stimulation of arm (conditioning) followed by Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle

Interventions

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TENS Stimulator

Initial stimulation of arm (conditioning) followed by Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle

Intervention Type DEVICE

Other Intervention Names

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TensMed S82 ENRAF-NONIUS

Eligibility Criteria

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Inclusion Criteria

* Generally healthy
* Ability to follow study instructions and complete study assessment tools

Exclusion Criteria

* History of cardiovascular disorders
* Any type of implanted pacemaker/defibrillator
* Hypertension
* Diabetes Mellitus
* Local dermatological disease
* Local skin irritation/lesions
* Any neurological disorder
* Any psychiatric disease and/or psychiatric medications
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Virility Medical Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ilan Gruenwald, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

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Rambam Health Care Campus

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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VM-Rev-001

Identifier Type: -

Identifier Source: org_study_id

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