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

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.

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Key information

Conditions

Premature Ejaculation Ejaculatory Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Rambam Health Care Campus

Haifa, Israel

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

TENS Stimulator

Device

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

Other names: TensMed S82 ENRAF-NONIUS

Primary outcomes

Incidence of Treatment-Emergent Adverse Events

Time frame: Baseline

Pain sensation score given by all subjects, as well as their verbal description of what they sensed during the various stimulations

Secondary outcomes

Incidence of post-treatment Adverse Events

Time frame: 72 hours

Post treatment safety evaluation completed by subjects (using safety questionnaire)

Sponsors and collaborators

Lead sponsor

Virility Medical Ltd.

Industry

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Jun 2, 2017
Registry last updated: Oct 8, 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.

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

Completed