Organic Erectile Dysfunction
Conditions
Keywords
erectile dysfunction, vibratory stimulation, viberect
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
Interventions
DEVICEViberect
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.
Sponsors
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Ease/Acceptability of Use of the Viberect as Assessed by EDITS Questionnaire | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Erectile Function (EF) as Assessed by the International Index for Erectile Function (IIEF)-5 Questionnaire | 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) | 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 | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 8 |
Baseline characteristics
| Characteristic | Viberect Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 50.9 years STANDARD_DEVIATION 11.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 11 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
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.
Time frame: week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Viberect Treatment | Acceptability of Use of the Viberect as Assessed by TSS | 38.3 score on a scale | Standard Deviation 16.1 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Viberect Treatment | Acceptability of Use of the Viberect as Assessed by TSS | 25 score on a scale | Standard Deviation 6.1 |
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.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Viberect Treatment | Assessment of Ease/Acceptability of Use of the Viberect as Assessed by EDITS Questionnaire | 21.3 score on a scale | Standard Deviation 16.1 |
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.
Time frame: Week 4
Population: Patient 1 data is missing.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Viberect Treatment | Assessment of Ease/Acceptability of Use of the Viberect as Assessed by EDITS Questionnaire | 15 score on a scale | Standard Deviation 12.7 |
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.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Viberect Treatment | EF as Assessed by the Erectile Hardness Score (EHS) | 2.66 score on a scale | Standard Deviation 0.5 |
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.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Viberect Treatment | EF as Assessed by the Erectile Hardness Score (EHS) | 2.33 score on a scale | Standard Deviation 0.5 |
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
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Viberect Treatment | EF as Assessed by the International Index for Erectile Function (IIEF)-5 Questionnaire | 16.3 score on a scale | Standard Deviation 1.52 |
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
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Viberect Treatment | Erectile Function (EF) as Assessed by the International Index for Erectile Function (IIEF)-5 Questionnaire | 14.6 score on a scale | Standard Deviation 1.15 |