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

Premature Ejaculation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03174470
• Other study ID #: VM-Rev-001
• Status: Completed
• Phase: N/A
• Start date: November 2, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: October 2019
• Source: Virility Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Ejaculation

Intervention

Device:
• TENS Stimulator
Initial stimulation of arm (conditioning) followed by Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Virility Medical Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events	Pain sensation score given by all subjects, as well as their verbal description of what they sensed during the various stimulations	Baseline
Secondary	Incidence of post-treatment Adverse Events	Post treatment safety evaluation completed by subjects (using safety questionnaire)	72 hours