CLINICAL STUDIES

Certifications:

FDA (USA), CE (European Union), ISO 13485:2003, CMDCAS, Health Canada, TGA (Australia), EN 60601-3, India

FDA Indications:

Class II medical device for home and clinic use to provoke penile erection in men with erectile dysfunction, and to provoke ejaculation in men with spinal cord injury.

CE Indications:

Penile vibratory stimulation device for the treatment of erectile and ejaculatory disorders.

PENILE ERECTION AND TREATMENT OF ED

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VIBERECT® DEVICE USE BY MEN WITH ERECTILE DYSFUNCTION: SAFETY, EASE OF USE, TOLERABILITY, AND SATISFACTION SURVEY

Kambiz Tajkarimi MD1 and Arthur L. Burnett MD, MBA2
1Summit Urology Group, Chambersburg, Pennsylvania; 2Johns Hopkins Medical Institutions, Baltimore MD Podium Poster, November 2011 SMSNA 2011, Las Vegas, Nevada

Introduction: Penile erection is a nerve generated vascular and mechanical event. Genital afferents activate spinal nuclei and higher centers responsible for sexual and urinary function. Viberect® is a new FDA−cleared medical device indicated to provoke erection and to treat anejaculation in spinal cord injured men. We report a preliminary survey of Viberect® use by men with erectile dysfunction (ED).

Patients and Methods: A representative sample of urology patients with ED (N = 10) were recruited (Table 1). Men were instructed by a unique repetitive reflex teaching program for optimal Viberect® experience. Viberect® stimulation was performed at home for 5−10 minutes at 70−110 Hz at least 3 times a week for one month. Treatment satisfaction was assessed by Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) and Treatment Satisfaction Scale (TSS).

Results: All men completed the surveys. No complaints or adverse events were reported. Viberect® was easy to use, painless, and acceptable. 90% were satisfied with the Viberect® treatment (EDITS Index >50); mean EDITS index score was 77. Mean TSS score was increased significantly from baseline (41.8) to active (66.8) (p< 0.01). 90% would continue Viberect® treatment and recommend its use to their friends.

Conclusion: This preliminary survey suggests Viberect® use by men with ED is a safe, convenient, well−tolerated, and highly satisfying modality for treatment of ED. Randomized prospective trials are necessary to authenticate these important findings.

Comparison of Viberect® to Intracavernosal Vasoactive Agents using penile Duplex Doppler Ultrasound evaluation of penile erection Suresh Sikka, Kambiz Tajkarimi, KhuloodKadhum, Mathew Freier, SreeMandava, Landon Trost, Arthur Burnett, and Wayne Hellstrom. Tulane University Department of Urology, New Orleans, Louisiana

Introduction and Objective: Viberect® is a new FDA-cleared vibratory medical device that stimulates genital afferent nerves and induces penile erection. The degree and quality of penile rigidity induced by Viberect® is unknown. This study evaluated penile blood flow parameters induced by Viberect® and compared findings to intracavernosal injection (ICI) of prostaglandin E1 (PGE1) using color duplex Doppler ultrasound (CDDU) technology.

Methods: Sixty-eight patients with ED underwent Viberect® stimulation prior to penile CDDU. Viberect® stimulation (simultaneous dorsal/ventral glans/corona and proximal shaft) was performed by the patient at 70 Hz frequency and amplitude of 2 mm for 6 minutes followed by immediate evaluation by CDDU as per Doppler ultrasound protocol. After flaccidity was attained, ICI using 7-15 mcg PGE1was administered and CDDU repeated.

Results: Twenty nine men ( “positive-responders” to Viberect®) demonstrated an 18-31% increased peak systolic velocity compared to ICI, with 90% tumescence and 60-70% rigidity (p=0.02). Seventeen patients (“borderline”) showed 80% tumescence and 30-40% rigidity with Viberect® which was 76-103% decreased compared to ICI. Only seven patients (“non-responders”) showed poor erection with Viberect®, but adequate response with 90% tumescence and 60% rigidity with PGE1 (147 - 171% difference; p=0.007).

Fifteen patients were unable to complete Viberect® stimulation due to impending ejaculation. No complaints of pain, priapism or other adverse events were reported with Viberect®.

Conclusions: Viberect® induces similar blood flow and erection responses as by ICI in the majority of patients undergoing CDDU evaluation. Stimulating the bulbocavernosus reflex with Viberect® is a safe, convenient, and well-tolerated modality for CDDU. Randomized prospective multicenter trials are needed to further validate these results and to assess the role of Viberect® during ED diagnosis.

Int J Impot Res. 1996 Dec;8(4):221-5.
Enhancement of erectile responses to vasoactive drugs by a variable amplitude oscillation device.
Chun SS, Fenemore J, Heaton JP, Johnston B, Morales A.
Department of Urology, Queen's University, Kingston, Ontario, Canada.

The limitations of intracavernosal injection (ICI) of vaso-active drugs as a diagnostic tool in the evaluation of erectile dysfunction are well recognized and, prominently, include the artifacts induced by the unfamiliar environment on the patient. We report on the benefits of adding a vibratory stimulus to ICI to improve the sensitivity of this test in a population of 170 patients with erectile dysfunction who were evaluated using a standard protocol. Intracavernosal pressure was measured following ICI alone and ICI with vibratory stimulation of the penis. A statistically significant improvement in intracavernosal pressure (ICP) with the addition of vibration was observed in 87% of the subjects as compared to ICI. In 52% the improvement in ICP was greater than 20% over that achieved by ICI. This study showed that the addition of vibration to intracavernosal administration of vaso-active drugs significantly increases the erectile response in a controlled and reproducible manner. Vibratory stimulation provides a better reflection of erectile potential than the pharmacological challenge alone.

Abstract

Objective Assessment of the Efficacy of the Viberect Device to Provoke Penile Erection in Men with no ED Johns Hopkins University Preliminary study

Introduction & Objectives

Current strategies employed to treat erectile dysfunction (ED) all target the vascular component of erections to achieve improved tumescence and rigidity for sexual intercourse. A new, FDA-approved treatment for ED, which exploits vibratory stimulation of genital afferent nerves as means of provoking erections, the Viberect® device, has not been rigorously assessed in clinical studies. The objective of this study was to objectively assess the efficacy of the Viberect® device to provoke erections in healthy men with no ED.

Methods

Six healthy subjects with normal erectile function as measured by responses to the IIEF-EF questionnaire were studied. The Erection Hardness Score (EHS) was used for subjective assessment of maximally rigid erection. Subjects were instructed on a penile stretching exercise meant to stimulate the bulbocavernosus reflex to achieve reflex erection. The Rigiscan device, set to the provocative ambulatory mode, was applied to the penis, and the Viberect® treatment initiated without any external visual sexual stimulation (VSS). Rigiscan measures of rigidity were recorded, as were adverse effects.

Results

Subjective assessments of erectile rigidity using the EHS for both the BCR stretching exercise as well as the Viberect® treatment did demonstrate a notable erectile response. 5/6 patients scored their maximal erection with the Viberect® device at 4/4 without the use of any visual sexual stimulation. Objective assessment with the Rigiscan did demonstrate the ability of the Viberect® to stimulate an erectile response, with a mean increase in penile basal girth of 2.3 cm, mean tumescence percentage above baseline of 24.5% and an average time of the tumescence episode beyond 55% total rigidity of 15%. There were no reported adverse effects, and all subjects felt that the Viberect® would be a reasonable, practical treatment for ED.

Conclusion

The results of this study provide evidence of an erectile stimulatory effect of penile vibratory stimulation utilizing the Viberect® device in healthy men without ED in the absence of VSS. These results provide proof that penile vibratory stimulation can be employed to provoke erections, and support further study of this modality in men with ED.

2009 Jul;6(7):1867-74. Epub 2009 Apr 24. Prevalence and characteristics of vibrator use by men in the United States. Reece M, Herbenick D, Sanders SA, Dodge B, Ghassemi A, Fortenberry JD. Center for Sexual Health Promotion, Indiana University, USA.

INTRODUCTION:

While vibrating products have been recommended by clinicians for the treatment of male sexual dysfunctions, knowledge is lacking with regard to the prevalence of vibrator use among men in the United States, the characteristics of men who use vibrators, and whether there are relations between vibrator use and sexual function among men.

AIMS:

To establish lifetime and recent prevalence rates for vibrator use by men in the United States, to document the characteristics of men who use vibrators and their reasons for using vibrators, and to explore relations between men's vibrator use and sexual function.

METHODS:

During April 2008, data were collected from a population-based cross-sectional survey of 1,047 men aged 18-60 years in the United States. Analyses were conducted using post-stratification data weights.

MAIN OUTCOME MEASURE:

Measures included sociodemographics, health status and health-related behaviors, sexual behaviors, vibrator use, and sexual function.

RESULTS:

For both solo and partnered sexual activities, the prevalence of men who had incorporated a vibrator into sexual activities during their lives was 44.8%, with 10.0% having done so in the past month, 14.2% in the past year, and 20.5% over 1 year ago. Men who had used vibrators, particularly those with more recent use, were more likely to report participation in sexual health promoting behaviors, such as testicular self-exam. Men who had used vibrators recently also scored higher on four of the five domains of the International Index of Erectile Function (erectile function, intercourse satisfaction, orgasmic function, and sexual desire).

CONCLUSIONS:

Among men in the United States, vibrator use during solo and partnered sexual interactions is common and is associated with a wide array of positive sexual health characteristics. Future research should continue to explore ways in which men incorporate vibrators into solo sexual acts, partnered sexual play, and sexual intercourse.

PENILE REHABILITATION AFTER PROSTATE CANCER SURGERY (PROSTATECTOMY)

Clinical Trials (clinicaltrials.gov)

Viberect Penile Vibratory Stimulation to Enhance Recovery of Erectile Function and Urinary Continence Post-Prostatectomy
(Expected completion date 2014)

Sponsor:Johns Hopkins University
Principal Investigator: Arthur L. Burnett, Johns Hopkins University Study of Non-Invasive Viberect® Penile Vibratory Stimulation Regimen to Enhance Recovery of Erectile Function/Rigidity and Urinary Control/Continence After Nerve Sparing Radical Prostatectomy (RP) for Clinically Localized Prostate Cancer.

Detailed Description: Prostate cancer screening programs have led to thousands of sexually healthy men being diagnosed with prostate cancer every year. Recent literature suggests that up to 80% of these cancers are confined to the prostate gland. Currently, radical prostatectomy (RP) remains the best option for management of clinically localized prostate cancer in men with life expectancy greater than 10 years. Despite providing optimal cancer control, surgery can lead to quality of life (QOL) problems such as urinary incontinence and erectile dysfunction (ED). Refinement of surgical technique have improved sexual and continence outcomes; however erectile function lags behind other QOL measures by 1-2 years, and quality of returning erections is often inferior. This can have profound biological, marital, and psychological consequences in potent men undergoing RP.

Erectile dysfunction (ED) is the inability to develop and maintain an erection for satisfactory sexual intercourse or activity. ED after nerve-sparing RP is related to a certain degree with functional impairment of cavernous nerves (CN) that travel along the prostate to the penis. This neuropraxia can last as long as 2 years. Pro-erectile nerve stimulus is vital for replenishment of corporal oxygen supply and other metabolic needs. Several histological analyses have demonstrated decreased smooth muscle number, cell-cell contact, venous leakage, collagen deposition, and additional harmful effects to corporal tissue after injury to CN.

Awaiting post-surgical neuropraxia recovery, urologists have proposed a proactive approach to use of oral, intraurethral or injectable pharmacotherapy, neuromodulation, or vacuum-assisted regimens in erectile rehabilitation programs. Several studies demonstrate variable functional improvement in erectile function. Unfortunately, prohibitive costs of medications, poor response, and pain from injectables or intraurethral application often lead to high dropout rates.

In addition to erectile dysfunction, a significant proportion of men after surgery develop and suffer from urinary incontinence (Stress, Urge, Mixed) requiring wearing pads with bothersome complaints persisting for months, even years after radical prostatectomy.

The primary objective is to assess the role of penile vibratory stimulation by the Viberect device in enhancing the recovery of erectile function/rigidity and urinary continence after radical prostatectomy for clinically localized prostate cancer. The difference in penile length will be compared in each arm.

Study Design:

Allocation:Randomized EndpointClassification: EfficacyStudy Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

Condition:

Erectile Dysfunction Following Radical Prostatectomy Urinary Incontinence of Non-organic Origin Intervention: Device: Viberect device Men who begin using the Viberect device 3 days after Foley catheter removal on daily (or at least 4 times a week) basis for 7-10 minutes in a relaxed setting with sexual thoughts or foreplay for one year. Viberect method can be performed by the person's sexual partner.

Study Arm (s)

Experimental: Viberect device Men in this group will begin using the Viberect device 3 days after Foley catheter removal after surgery on daily (or at least 4 times a week) basis for 7-10 minutes in a relaxed setting.

Intervention: Device: Viberect device No Intervention: No Viberect Men in this group will not be provided with the Viberect device.

Eligibility Criteria:

Inclusion Criteria:

Patients with biopsy proven low/moderate risk prostate cancer (Gleason 3+3=6, 3+4=7, 3+2=5, 2+3=5, cT1c, cT2a, cT2b, PSA less than 10)

  • between ages 40-70
  • preoperative IIEF (erectile function section) score equal or greater than 20
  • AUA symptom score less than 10 and no urinary incontinence

Exclusion Criteria:

  • Men with neurological disease
  • IIEF score less than 20
  • high risk prostate cancer (Gleason 4+3=7, 4+4=8, any Gleason 5, cT2c, cT3, PSA > 10)
  • spinal cord injury
  • history of transurethral resection of prostate (TURP) or other prostate ablative procedures
  • history of priapism, pelvic neuropathy, penile skin lesions/ulcers
  • inability to understand and demonstrate device use instructions
  • .

TREATMENT OF EJACULATORY DYSFUNCTION IN MEN WITH SPINAL CORD INJURY

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RETARDED ORGASM

Urology. 2007 Mar;69(3):552-5; discussion 555-6.

Assessment of penile vibratory stimulation as a management strategy in men with secondary retarded orgasm.

Nelson CJ, Ahmed A, Valenzuela R, Parker M, Mulhall JP.

Source

Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, New York 10022, USA. nelsonc@mskcc.org

Abstract

OBJECTIVES:

To evaluate the effectiveness of penile vibratory stimulation for the management of retarded orgasm. Retarded orgasm, a condition characterized by difficulty achieving orgasm and ejaculation, is one of the most recalcitrant of the male sexual dysfunctions. Currently, no evidence-based treatments have been proven to ameliorate this condition.

METHODS:

Men who had a complete inability to achieve an orgasm during sexual relations in the previous 3 months were instructed in the use of penile vibratory stimulation using the Ferticare device. The men's responses were measured by self-report of orgasm function and using the orgasm and satisfaction domains of the International Index of Erectile Function. The responses were assessed at baseline (admission into the study) and at 3 and 6 months.

RESULTS:

A total of 36 men met the inclusion criteria, and 72% reported the restoration of orgasm. These responders reported that orgasm during sexual relations occurred 62% of the time. A statistically and clinically significant increase occurred in the orgasm and satisfaction domains of the International Index of Erectile Function between the baseline visit and the 3-month follow-up visit. These gains were sustained at 6 months.

CONCLUSIONS:

Penile vibratory stimulation is an effective treatment for retarded orgasm. Penile vibratory stimulation should be integrated into current cognitive-behavioral sex therapy techniques to achieve maximal effectiveness and satisfaction.

BASIC SCIENCE AND GENITAL AFFERENT NEUROPHYSIOLOGY

The role of genital nerve afferents in the physiology of the sexual response and pelvic floor function.

Tajkarimi K, Burnett AL. Johns Hopkins Medical Institutions Journal of Sexual Medicine, May 2011

INTRODUCTION:

Our understanding of genital and pelvic floor physiology is rapidly expanding. Penile erection is a neurovascular event controlled by spinal autonomic centers, the activity of which is dependent on input from supraspinal centers and the genitalia. Genital afferent stimulation excites spinal autonomic nuclei and supraspinal sexual centers of both genders.

AIM:

To present a detailed understanding of the functional importance of genital afferent neuroanatomy and neurophysiology.

METHODS:

English-written articles of diverse disciplines from 1980 to 2010 that contained information on genital anatomy, pudendal/dorsal/perineal/cavernous nerves, vibratory stimulation, reflexogenic erection, peripheral/central nervous system-mediated erectile and micturition pathways, and sexual arousal in animals and humans were reviewed.

MAIN OUTCOME MEASURES:

Analysis of supporting evidence for the role of genital afferents in the physiology of erectile response and pelvic floor function.

RESULTS:

Basic science and clinical studies support the concept that pudendal nerve circuitry serves an essential purpose for sexual behavior, erectile function, penile rigidity, ejaculation, and micturition. Males and females share a comparable pattern of genital afferent neuroanatomy and neurophysiology, and sexual and micturition reflexes are similar in both genders. Pudendal nerve branches communicate with the cavernous nerves and are nitric oxide synthase positive. Genital afferents activate multiple spinal reflexes that modulate erection and micturition. Genital sensory information is transmitted to supraspinal centers important for sexual function.

CONCLUSIONS:

There is expanding support for the critical role of genital afferent neurophysiology in the mechanisms of erectile function and micturition. Genital afferent stimulation is a safe and natural modality that can be harnessed to amplify autonomic and somatic activity within the penis, female genitalia, spinal cord, and higher centers via established neurological principles. Such physiological adaptive processes may be beneficial in improving sexual response, erectile function, and micturition in many disease states, including in men after radical pelvic surgery. Well-designed and -executed studies in each specific population are needed to authenticate such prospects.



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Certifications

Certifications:
FDA, CE, ISO 13485:2003, CMDCAS, Health Canada; TGA

FDA Indications:
Class II medical device for home and clinic use to provoke penile erection in men with erectile dysfunction, and to provoke ejaculation in men with spinal cord injury.

CE Indications:
Penile vibratory stimulation device for the treatment of erectile and ejaculatory disorders.

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