Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-30 @ 7:07 PM
Study NCT ID:
NCT01718704
Status:
WITHDRAWN
Last Update Posted:
2019-05-24
First Post:
2012-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Viberect Penile Vibratory Stimulation to Enhance Recovery of Erectile Function and Urinary Continence Post-Prostatectomy
Sponsor:
Johns Hopkins University
Organization:
Study Overview
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.
Status:
WITHDRAWN
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was stopped due to inability to accrue patients because of competing trials.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: