Clinical trial NCT01715571: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Organic Erectile Dysfunction
Keywords: erectile dysfunction
vibratory stimulation
viberect
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2012-10-29
Enrollment: 11
Sex: MALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Assessment of Ease/Acceptability of Use of the Viberect as Assessed by EDITS Questionnaire
timeFrame: baseline
measure: Acceptability of Use of the Viberect as Assessed by TSS
timeFrame: Baseline
measure: Assessment of Ease/Acceptability of Use of the Viberect as Assessed by EDITS Questionnaire
timeFrame: Week 4
measure: Acceptability of Use of the Viberect as Assessed by TSS
timeFrame: week 4
Secondary outcomes:
measure: Erectile Function (EF) as Assessed by the International Index for Erectile Function (IIEF)-5 Questionnaire
timeFrame: baseline
measure: EF as Assessed by the Erectile Hardness Score (EHS)
timeFrame: baseline
measure: EF as Assessed by the International Index for Erectile Function (IIEF)-5 Questionnaire
timeFrame: Week 4
measure: EF as Assessed by the Erectile Hardness Score (EHS)
timeFrame: Week 4
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Frederick
country: United States
facility: Frederick Urology Specialists
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Arthur L Burnett, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: