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

This study is currently recruiting participants.
Verified June 2017 by Virility Medical Ltd.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03177226
First Posted: June 6, 2017
Last Update Posted: June 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Virility Medical Ltd.
  Purpose
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.

Condition Intervention
Premature Ejaculation Device: Functional TENS stimulation Device: Non-Functional TENS stimulation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Device Feasibility
Official Title: Safety & Feasibility of Functional Electrical Stimulation for The Treatment of Premature Ejaculation

Further study details as provided by Virility Medical Ltd.:

Primary Outcome Measures:
  • 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)

  • 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


Secondary Outcome Measures:
  • Incidence of post-treatment Adverse Events [ Time Frame: 72 hours ]
    Post treatment safety evaluation completed by subjects (using safety questionnaire)


Other Outcome Measures:
  • Effects of applied electrical stimulation on Erection using Self Reported - User Questionnaire [ Time Frame: Procedure day ]
    Self reported - user questionnaire


Estimated Enrollment: 30
Actual Study Start Date: January 2017
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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]
Device: Functional TENS stimulation
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 Name: 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]
Device: Non-Functional TENS stimulation
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'

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177226


Contacts
Contact: Ilan Gruenwald, MD +972-4-777-2819

Locations
Israel
Rambam Health Care Campus Recruiting
Haifa, Israel
Contact: Ilan Gruenwald, MD    +972-4-777-2819      
Sponsors and Collaborators
Virility Medical Ltd.
Investigators
Principal Investigator: Ilan Gruenwald, MD Rambam Health Care Campus
  More Information

Responsible Party: Virility Medical Ltd.
ClinicalTrials.gov Identifier: NCT03177226     History of Changes
Other Study ID Numbers: VM II-Rev-001
First Submitted: May 28, 2017
First Posted: June 6, 2017
Last Update Posted: June 6, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Premature Birth
Premature Ejaculation
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders