Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Symptoms and General Pathology

Musculoskeletal Diseases

Nervous System Diseases

Prostatic Neoplasms

Erectile Dysfunction

Urinary Incontinence

Enuresis

Muscle Rigidity

Nocturnal Enuresis

Urination Disorders

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Lower Urinary Tract Symptoms

Urological Manifestations

Behavioral Symptoms

Elimination Disorders

Mental Disorders

Psychotic Disorders

Genital Diseases

Genital Diseases, Male

Sexual Dysfunction, Physiological

Sexual Dysfunctions, Psychological

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

Men in this group will not be provided with the Viberect device

Men who begin using the Viberect device 3 days after Foley catheter removal on a 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.

Viberect device

Arthur L Burnett, MD, MBA

The purpose of this study is to evaluate whether using penile vibratory stimulation with the Viberect handheld device can help the recovery of erections and urinary control after radical prostatectomy.

Prostate cancer screening programs have led to thousands of sexually healthy and continent 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.

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 ED, 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 RP.

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 RP for clinically localized prostate cancer. The difference in penile length will be compared in each arm.

The secondary objective is to obtain a formal risk analysis (RA). Other objectives are to assess the ease of use and acceptability of vibratory stimulation at home.

Viberect Penile Vibratory Stimulation to Enhance Recovery of Erectile Function and Urinary Continence Post-Prostatectomy

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.

The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire will be administered. This is an 11 item tool addressing participant satisfaction with the Viberect; higher scores indicate greater dissatisfaction

The Treatment Satisfaction Scale (TSS) questionnaire will be administered. This is an 21 item tool addressing participant satisfaction with the Viberect; higher scores indicate greater dissatisfaction

The International Index for Erectile Function (IIEF) questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function over the previous 4 weeks. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction

IIEF questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function over the previous 4 weeks. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction

The Expanded Prostate Cancer Index Composite (EPIC) sexual assessment questionnaire will be administered. The tool has 9 questions about erectile function over the previous 4 weeks. It is scored from 9 - 43 with higher scores indicating greater dysfunction

The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single item tool. It is scored from 1 to 4. 4 indicates attainment of full rigidity with ability to perform penetrative intercourse

Measurement of penile length from corona to dorsal glans penis in centimeters

The Expanded Prostate Cancer Index Composite (EPIC) urinary function assessment questionnaire will be administered. This is a 7 item tool assessing urinary function over the past 4 weeks. Higher scores indicate decreased urinary control

Mass of incontinence guards used over a 24 hour period in grams

The International Prostate Symptom Score (IPSS) Questionnaire will be administered. 7 questionnaires address urinary control with a total attainable score from 0-35. 0 = no dysfunction, 1-7 = mild dysfunction, 8 - 19 = moderate dysfunction, 20-35 = severe dysfunction. The 8th/final item addresses impact of urinary control on quality of life

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Viberect Penile Vibratory Stimulation to Enhance Recovery of Erectile Function and Urinary Continence Post-Prostatectomy	NCT01718704	Erectile Dysfun... Urinary Inconti...	Viberect device	40 Years - 70 Years	Johns Hopkins University
Viberect Penile Vibratory Stimulation to Enhance Recovery of Erectile Function and Urinary Continence Post-Prostatectomy	NCT01718704	Erectile Dysfun... Urinary Inconti...	Viberect device	40 Years - 70 Years	Johns Hopkins University
Viberect Penile Vibratory Stimulation to Enhance Recovery of Erectile Function and Urinary Continence Post-Prostatectomy	NCT01718704	Erectile Dysfun... Urinary Inconti...	Viberect device	40 Years - 70 Years	Johns Hopkins University
Viberect Penile Vibratory Stimulation to Enhance Recovery of Erectile Function and Urinary Continence Post-Prostatectomy	NCT01718704	Erectile Dysfun... Urinary Inconti...	Viberect device	40 Years - 70 Years	Johns Hopkins University

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