- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01715571
Assessment of Penile Vibratory Stimulation Using the Viberect in Men With Mild-Moderate ED
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
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Hospital
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Frederick, Maryland, United States, 21701
- Frederick Urology Specialists
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline
|
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.
|
Baseline
|
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.
|
Week 4
|
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.
|
week 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
baseline
|
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.
|
baseline
|
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
|
Week 4
|
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.
|
Week 4
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00130002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Viberect
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