Safety & Feasibility of Functional Electrical Stimulation for The Treatment of Premature Ejaculation

June 1, 2017 updated by: Virility Medical Ltd.
Prospective, non-randomized, controlled, single-center study, to evaluate the efficacy of applied nominal electrical stimulation parameters given to premature ejaculation (PE) patients in order to prolong the ejaculatory latency time which will eventually increase the quality of their sexual life.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ilan Gruenwald, MD
  • Phone Number: +972-4-777-2819

Study Locations

      • Haifa, Israel
        • Recruiting
        • Rambam Health Care Campus
        • Contact:
          • Ilan Gruenwald, MD
          • Phone Number: +972-4-777-2819

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Good general health
  • Clinical history of premature ejaculation
  • Familiar with self- stimulation
  • Ability to follow study instructions and complete study assessment tools
  • Washout period of two weeks

Exclusion Criteria:

  • History of cardio-vascular 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 any psychiatric medications
  • Any neoplastic disease in the past two years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Functional TENS stimulation
Short stimulation to identifying Sensory Threshold and Motor Threshold, followed by continuous functional electrical stimulation, throughout the entire self-stimulation phase [from full erection to ejaculation]
A short continuous electrical stimulation, beginning at 0 mAmp and gradually increased by +0.5 mAmp every 2-10 sec to identifying Sensory Threshold (Is) and Motor Threshold (Imc), followed by continuous functional electrical stimulation, throughout the entire self-stimulation phase, equal to his Icm'
Other Names:
  • 1427970 TensMed S82
Sham Comparator: Non-stimulation treatment
Short stimulation to identifying Sensory Threshold and Motor Threshold, followed by continuous non-functional electrical stimulation, throughout the entire self-stimulation phase [from full erection to ejaculation]
A short continuous electrical stimulation, beginning at 0 mAmp and gradually increased by +0.5 mAmp every 2-10 sec to identifying Sensory Threshold (Is) and Motor Threshold (Imc), followed by continuous non-functional electrical stimulation, throughout the entire self-stimulation phase, equal to his Icm'

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events
Time Frame: Procedure day
All Self reported safety events (e.g. discomfort, pain, local irritation, local heat, noticeable changes in urination or bowl activity or any other complaint)
Procedure day
Change in ejaculation latency time
Time Frame: Procedure day
The difference between patient ejaculation latency time under perineal functional electrical stimulation during self-stimulation, and latency time during self-stimulation while no electrical stimulation is applied
Procedure day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of post-treatment Adverse Events
Time Frame: 72 hours
Post treatment safety evaluation completed by subjects (using safety questionnaire)
72 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of applied electrical stimulation on Erection using Self Reported - User Questionnaire
Time Frame: Procedure day
Self reported - user questionnaire
Procedure day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ilan Gruenwald, MD, Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

May 28, 2017

First Submitted That Met QC Criteria

June 1, 2017

First Posted (Actual)

June 6, 2017

Study Record Updates

Last Update Posted (Actual)

June 6, 2017

Last Update Submitted That Met QC Criteria

June 1, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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