Assessment of Penile Vibratory Stimulation Using the Viberect in Men With Mild-Moderate ED

• ClinicalTrials.gov Identifier: NCT01715571
• Recruitment Status: Terminated
• First Posted: October 29, 2012
• Results First Posted: June 23, 2021
• Last Update Posted: June 23, 2021
• Sponsor: Johns Hopkins University
• Information provided by (Responsible Party): Johns Hopkins University

Tracking Information

• First Submitted Date: October 21, 2012
• First Posted Date: October 29, 2012
• Results First Submitted Date: May 14, 2021
• Results First Posted Date: June 23, 2021
• Last Update Posted Date: June 23, 2021
• Actual Study Start Date: March 1, 2013
• Actual Primary Completion Date: June 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 21, 2021)

• Assessment of Ease/Acceptability of Use of the Viberect as Assessed by EDITS Questionnaire [ Time Frame: baseline ]
  The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire will be administered. This is an 11 item tool addressing participant satisfaction with the Viberect. Each item is a 5-point Likert-type scale from 0 "no satisfaction or dissatisfaction" to 4 "high satisfaction." Total scoring ranges from 0-44 with higher scores indicating higher treatment satisfaction.
• Acceptability of Use of the Viberect as Assessed by TSS [ Time Frame: Baseline ]
  The Treatment Satisfaction Scale (TSS) questionnaire (patient baseline module) will be administered addressing participant satisfaction before Viberect treatment; This is an 8 item tool and each item is a 5-point Likert-type scale from 1 to 5. The score range for TSS is 8-40 with higher scores indicating greater dissatisfaction.
• Assessment of Ease/Acceptability of Use of the Viberect as Assessed by EDITS Questionnaire [ Time Frame: Week 4 ]
  The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire will be administered. This is an 11 item tool addressing participant satisfaction with the Viberect. Each item is a 5-point Likert-type scale from 0 "no satisfaction or dissatisfaction" to 4 "high satisfaction." Total scoring ranges from 0-44 with higher scores indicating higher treatment satisfaction.
• Acceptability of Use of the Viberect as Assessed by TSS [ Time Frame: week 4 ]
  The Treatment Satisfaction Scale (TSS) questionnaire (patient active treatment module) will be administered addressing participant satisfaction following Viberect treatment; This is a 13 item tool and each item is a 5-point Likert-type scale from 1 to 5. The score range for TSS is 13-65 with higher scores indicating greater dissatisfaction.

Original Primary Outcome Measures (submitted: October 24, 2012)

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 ]

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

Current Secondary Outcome Measures (submitted: June 21, 2021)

• Erectile Function (EF) as Assessed by the International Index for Erectile Function (IIEF)-5 Questionnaire [ Time Frame: baseline ]
  The International Index for Erectile Function (IIEF)-5 questionnaire will be administered. This is a 5 item tool; addressing Erectile function over the previous 4 weeks. Scores from 1-25 can be obtained in this domain. Scores are interpreted as follows: 1-7 = Severe Erectile dysfunction (ED), 8-11 = Moderate ED, 12-16 = mild-moderate ED, 17-21 = mild ED, 22-25 = No ED
• EF as Assessed by the Erectile Hardness Score (EHS) [ Time Frame: baseline ]
  The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single-item tool. It is scored from 1 to 4. Higher scores indicate better erection rigidity.
• EF as Assessed by the International Index for Erectile Function (IIEF)-5 Questionnaire [ Time Frame: Week 4 ]
  The International Index for Erectile Function (IIEF)-5 questionnaire will be administered. This is a 5 item tool; addressing Erectile function over the previous 4 weeks. Scores from 1-25 can be obtained in this domain. Scores are interpreted as follows: 1-7 = Severe Erectile dysfunction (ED), 8-11 = Moderate ED, 12-16 = mild-moderate ED, 17-21 = mild ED, 22-25 = No ED
• EF as Assessed by the Erectile Hardness Score (EHS) [ Time Frame: Week 4 ]
  The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single-item tool. It is scored from 1 to 4. Higher scores indicate better erection rigidity.

Original Secondary Outcome Measures (submitted: October 24, 2012)

To assess safety of using Viberect penile stiumulation for the treatment of mild-moderate ED [ Time Frame: 4 weeks after initiation of intervention ]

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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Assessment of Penile Vibratory Stimulation Using the Viberect in Men With Mild-Moderate ED
• 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 ED
• Brief Summary: 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.

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 ED

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Organic Erectile Dysfunction

Intervention

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.

Study Arms

Experimental: Viberect treatment

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: June 21, 2021): 11
• Original Estimated Enrollment (submitted: October 24, 2012): 50
• Actual Study Completion Date: July 1, 2020
• Actual Primary Completion Date: June 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria

• mild-moderate erectile dysfunction based on International Index of Erectile Function (IIEF) erectile function score 13-25

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 30 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01715571
• Other Study ID Numbers: IRB00130002
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Johns Hopkins University
• Original Responsible Party: Arthur L. Burnett, M.D., Johns Hopkins University, Patrick C. Walsh Professor of Urology, Cellular and Molecular Medicine
• Current Study Sponsor: Johns Hopkins University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Arthur L Burnett, MD, MBA; Johns Hopkins University

• PRS Account: Johns Hopkins University
• Verification Date: June 2021