Erectile Dysfunction Following Radical Prostatectomy Clinical Trial
Official title:
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 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.
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