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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

October 21, 2012
September 20, 2016
March 2013
December 2018   (final data collection date for primary outcome measure)
  • 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
To assess daily or on-demand ease of use, and efficacy of the home use of the Viberect device by men with mild to moderate and no erectile dysfunction [ Time Frame: 4 weeks after initiation of intervention ] [ Designated as safety issue: No ]
After obtaining informed consent, the subjects will be instructed in the use of the Viberect device, and will be asked to perform vibratory stimulation of the penis in the privacy of their home, while focused on sexual/erotic 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. They will fill out several validated questionnaires on week 4: Erection Hardness Scale (EHS), EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction), TSS questionnaire
Complete list of historical versions of study NCT01715571 on ClinicalTrials.gov Archive Site
  • 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
To assess safety of using Viberect penile stiumulation for the treatment of mild-moderate ED [ Time Frame: 4 weeks after initiation of intervention ] [ Designated as safety issue: Yes ]
After obtaining informed consent, the subjects will be instructed in the use of the Viberect device, and will be asked to perform vibratory stimulation of the penis in the privacy of their home, while focused on sexual/erotic 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. They will fill out several validated questionnaires on week 4: Erection Hardness Scale (EHS), EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction), TSS questionnaire
Not Provided
Not Provided
 
Assessment of Penile Vibratory Stimulation Using the Viberect in Men With Mild-Moderate and No Erectile Dysfunction
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.
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Organic Erectile Dysfunction
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 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
    Intervention: Device: Viberect
  • 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
    Intervention: Device: Viberect
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2018
December 2018   (final data collection date for primary outcome measure)

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
Male
30 Years to 70 Years   (Adult, Senior)
Yes
Contact: Kambiz Tajkarimi, MD 1-202-321-8162 Kambiz123@hotmail.com
Contact: Jordan Dimitrakoff, MD, PhD (410) 502-5384 jdimitr1@jhmi.edu
United States
 
NCT01715571
NA_00052709
No
Not Provided
Not Provided
Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Arthur L Burnett, MD, MBA Johns Hopkins University
Johns Hopkins University
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP