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 2013 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Arthur L. Burnett, M.D., Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01715571
First received: October 21, 2012
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

The primary purpose of this study is to assess the safety, acceptability, and satisfaction of penile vibratory stimulation. The secondary purpose 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:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 50
Study Start Date: March 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: men with mild-mod. erectile dysfunction

Expected duration of subject participation: 4 weeks Initial visit: to perform history and physical, to discuss the clinical study and obtain informed consent. Study subjects will fill out the International Index of erectile Function (IIEF) questionnaire, the Erection hardness Score (EHS), the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire and the Treatment Satisfaction Survey (TSS) to fill out after 4 weeks, and receive instructions on the use of the Viberect device, including the User manual.

Follow up visit four weeks later: To return the Viberect device and collect the completed forms. The patient will have a penile examination to document any sores, lesions, or irritation.

Device: Viberect

Men 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.

Experimental: men with no erectile dysfunction

Expected duration of subject participation: 4 weeks Initial visit: to perform history and physical, to discuss the clinical study and obtain informed consent. Study subjects will fill out the International Index of erectile Function (IIEF) questionnaire, the Erection hardness Score (EHS), the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire and the Treatment Satisfaction Survey (TSS) to fill out after 4 weeks, and receive instructions on the use of the Viberect device, including the User manual.

Follow up visit four weeks later: To return the Viberect device and collect the completed forms. The patient will have a penile examination to document any sores, lesions, or irritation.

Device: Viberect

Men 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.


Detailed Description:

Erectile dysfunction (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 erectile dysfunction. 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 three pro-erectile medications currently in the market.

Penile vibratory stimulation mimics rapid and repetitive manual/hand stimulation of the penis, which is a natural aspect of human sexual behavior. For more than a century, tens of millions of women use vibratory devices on daily/regular basis for purpose of sexual pleasure/orgasm. Vibratory stimulation of genitalia is considered safe by the medical community with important benefits, such as treatment of orgasmic dysfunction, stress urinary incontinence, ejaculation, and erection. No significant physical or emotional side-effects have been reported in the medical literature, or the popular media. 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 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 reflexogenic gradual filling of the penis (minutes) with arterial blood by activating the pudendo-cavernosal reflex. Additional physiological effects include progressive rhythmic contraction of the perineal muscles via activation of 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.

The purpose of this multicenter study is to assess daily or on-demand ease of use, safety, satisfaction, and efficacy of the home use of the Viberect device (FDA cleared) by men with mild to moderate and no erectile dysfunction.

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • mild-moderate erectile dysfunction-IIEF-EF score 13-25
  • no erectile dysfunction-IIEF-EF 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

No publications provided

Responsible Party: Arthur L. Burnett, M.D., Patrick C. Walsh Professor of Urology, Cellular and Molecular Medicine, 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, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 31, 2014