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Unable to obtain adequate recruitment
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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 ED
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Viberect treatment | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Viberect | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Ease/Acceptability of Use of the Viberect as Assessed by EDITS Questionnaire | 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 | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Erectile Function (EF) as Assessed by the International Index for Erectile Function (IIEF)-5 Questionnaire | 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 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Arthur L Burnett, MD, MBA | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States | ||
| Frederick Urology Specialists |
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| ID | Title | Description |
|---|---|---|
| FG000 | Viberect Treatment | Single-center, non-randomized, single-arm study The Viberect device was used for 7-10 minutes at least 3 times each week, at least 24 hours apart, 4 weeks period |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Viberect Treatment | Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Assessment of Ease/Acceptability of Use of the Viberect as Assessed by EDITS Questionnaire | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline |
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Viberect Treatment | Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity |
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Among the limitations of this study are the small number of subjects, short duration of therapy, and a single-arm design with no control group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arthur Burnett, MD | Johns Hopkins University School of Medicine | 410-614-3986 | aburnet1@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 12, 2018 | May 19, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 7, 2021 | May 14, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 2, 2018 | May 24, 2021 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| baseline |
| EF as Assessed by the Erectile Hardness Score (EHS) | 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 | 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) | 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 |
| Frederick |
| Maryland |
| 21701 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Acceptability of Use of the Viberect as Assessed by TSS | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Primary | Assessment of Ease/Acceptability of Use of the Viberect as Assessed by EDITS Questionnaire | 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. | Patient 1 data is missing. | Posted | Mean | Standard Deviation | score on a scale | Week 4 |
|
|
|
| Primary | Acceptability of Use of the Viberect as Assessed by TSS | 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. | Posted | Mean | Standard Deviation | score on a scale | week 4 |
|
|
|
| Secondary | Erectile Function (EF) as Assessed by the International Index for Erectile Function (IIEF)-5 Questionnaire | 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 | Posted | Mean | Standard Deviation | score on a scale | baseline |
|
|
|
| Secondary | EF as Assessed by the Erectile Hardness Score (EHS) | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline |
|
|
|
| Secondary | EF as Assessed by the International Index for Erectile Function (IIEF)-5 Questionnaire | 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 | Posted | Mean | Standard Deviation | score on a scale | Week 4 |
|
|
|
| Secondary | EF as Assessed by the Erectile Hardness Score (EHS) | 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. | Posted | Mean | Standard Deviation | score on a scale | Week 4 |
|
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|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
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| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |