Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Assessment of Penile Vibratory Stimulation Using the Viberect in Men With Mild-Moderate and No Erectile Dysfunction

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01715571
First received: October 21, 2012
Last updated: September 20, 2016
Last verified: September 2016
  Purpose
The primary objective of this study is to assess the safety, acceptability, and satisfaction of penile vibratory stimulation in treatment of erectile dysfunction (ED). The secondary objective is to demonstrate subjective physiological response (erection, rigidity, orgasm) after four weeks of frequent device use and the satisfaction of penile erection and sexual intercourse with partner.

Condition Intervention
Organic Erectile Dysfunction
Device: Viberect

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical and Physiological Assessment of Noninvasive Penile Afferent Vibratory Stimulation of Both Surfaces of the Penis Using the Viberect® Device in Men With Mild to Moderate and No Erectile Dysfunction.

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • change in erectile function (EF) [ Time Frame: baseline to 4 weeks post intervention ] [ Designated as safety issue: No ]
    The International Index for Erectile Function (IIEF) questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function over the previous 4 weeks. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction

  • change in EF [ Time Frame: baseline to 4 weeks post intervention ] [ Designated as safety issue: No ]
    The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single item tool. It is scored from 1 to 4. 4 indicates attainment of full rigidity with ability to perform penetrative intercourse


Secondary Outcome Measures:
  • Assessment of ease and acceptability of use of the Viberect [ Time Frame: 4 weeks post intervention ] [ Designated as safety issue: No ]
    The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire will be administered. This is an 11 item tool addressing participant satisfaction with the Viberect; higher scores indicate greater dissatisfaction

  • change in assessment of ease and acceptability of use of the Viberect [ Time Frame: baseline to 4 weeks post intervention ] [ Designated as safety issue: No ]
    The Treatment Satisfaction Scale (TSS) questionnaire will be administered. This is a 21 item tool addressing participant satisfaction with the Viberect; higher scores indicate greater dissatisfaction


Estimated Enrollment: 50
Study Start Date: March 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: men with mild to moderate ED
Participants in this arm have documented mild to moderate ED of organic etiology and will be given the Viberect device for 4 weeks of daily home use in preparation for sexual activity. Men will be asked to use the device and attempt sexual intercourse at least 3 times weekly
Device: Viberect

Men will be asked to perform vibratory stimulation of the penis in the privacy of their home, while focused on sexual thoughts for approximately 7-10 minutes (depending on erectile response) for 3 times a week, one day apart, throughout the four week period. Men can perform the stimulation once daily, as long as each session is more than 24 hours apart.

Men will record device use and intercourse attempts after device use in a diary.

Experimental: men with no erectile dysfunction
Participants in this arm have no erectile dysfunction and will be given the Viberect device for 4 weeks of daily home use in preparation for sexual activity. Men will be asked to use the device and attempt sexual intercourse at least 3 times weekly
Device: Viberect

Men will be asked to perform vibratory stimulation of the penis in the privacy of their home, while focused on sexual thoughts for approximately 7-10 minutes (depending on erectile response) for 3 times a week, one day apart, throughout the four week period. Men can perform the stimulation once daily, as long as each session is more than 24 hours apart.

Men will record device use and intercourse attempts after device use in a diary.


Detailed Description:

ED is the inability to develop and maintain an erection for satisfactory sexual intercourse or activity. ED is a highly prevalent medical condition often associated with multiple causes. It is estimated that more than 50 million American men suffer from mild/moderate to severe ED. Roughly 50% of men in their 50's, 60% of men in their 60's, and 70% of men in their 70's suffer from ED. The economic impact of ED is in the billions of dollars. More than 5 billion dollars a year are spent on the pro-erectile medications currently in the market.

Penile vibratory stimulation mimics rapid and repetitive manual/hand stimulation of the penis. Vibratory stimulation of genitalia is considered safe by the medical community with important benefits including treatment of orgasmic dysfunction and stress urinary incontinence. No significant physical or emotional side-effects have been reported in the medical literature. A recent epidemiological study of the use of vibrators by American women and men has shown no complaints, and generally high satisfaction and improvement in sexual response.

Penile erection is controlled by spinal autonomic centers, the activity of which is dependent on input from supraspinal centers and the genitalia. From a neurophysiological viewpoint, scientists believe that penile erection is a culmination of multiple successful nerve reflexes that initiate a vascular event. Simultaneous vibratory stimulation of both surfaces of the penis at high frequency (70-110 Hz) for 7-10 minutes can lead to gradual filling of the penis with arterial blood within minutes by activating the pudendo-cavernosal reflex. Additional physiological effects include progressive rhythmic contraction of the perineal muscles via the bulbocavernosus reflex, which helps in strengthening rigidity of erection. This will prepare the user for successful sexual intercourse. Subsequent orgasm and ejaculation can be very strong and amplified due to stronger contraction of the bulbospongiosus muscle and activation of higher ejaculatory centers.

This study will assess daily or on-demand ease of use, safety, satisfaction, and efficacy of the home use of the Food and Drug Administration (FDA) cleared Viberect device by men with mild to moderate and no ED.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • mild-moderate erectile dysfunction based on International Index of Erectile Function (IIEF) erectile function score 13-25
  • no erectile dysfunction-IIEF erectile function score equal or greater than 25

Exclusion Criteria

  • Men with neurological disease
  • IIEF score less than 13
  • Spinal cord injury
  • History of priapism
  • Pelvic neuropathy
  • Post-prostatectomy
  • Penile skin lesions or ulcers
  • Inability to understand and demonstrate device use instructions
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01715571

Contacts
Contact: Kambiz Tajkarimi, MD 1-202-321-8162 Kambiz123@hotmail.com
Contact: Jordan Dimitrakoff, MD, PhD (410) 502-5384 jdimitr1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Jordan Dimitrakoff, M.D., Ph.D.    410-502-5384    jdimitr1@jhmi.edu   
Contact: Brian Le, M.D.       ble6@jhmi.edu   
Principal Investigator: Arthur L Burnett, MD, MBA         
Frederick Urology Specialists Recruiting
Frederick, Maryland, United States, 21701
Contact       ble6@jhmi.edu   
Principal Investigator: Kambiz Tajkarimi, MD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Arthur L Burnett, MD, MBA Johns Hopkins University
  More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01715571     History of Changes
Other Study ID Numbers: NA_00052709 
Study First Received: October 21, 2012
Last Updated: September 20, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
erectile dysfunction
vibratory stimulation
viberect

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders

ClinicalTrials.gov processed this record on December 02, 2016