Viberect Penile Vibratory Stimulation to Enhance Recovery of Erectile Function and Urinary Continence Post-Prostatectomy
Recruitment status was Recruiting
Erectile Dysfunction Following Radical Prostatectomy
Urinary Incontinence of Non-organic Origin
Device: Viberect device
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- Recovery of erectile function following radical prostatectomy. [ Time Frame: 12 months post-radical prostatectomy ] [ Designated as safety issue: No ]Patients will visit with investigators. Physical examination will be performed, including genital exam for any signs of penile irritation. Study subjects will complete the IIEF, EPIC urinary and sexual domain, AUA, EHS, EDITS and TSS questionnaires. Penile length will be measured from pubis to corona of the glans penis (dorsally) and recorded in centimeter using a standard wooden ruler.
- Recovery of continence after radical prostatectomy [ Time Frame: 12 months post-prostatectomy ] [ Designated as safety issue: No ]Patients will visit with investigators. Physical examination will be performed, including genital exam for any signs of penile irritation. Study subjects will complete the IIEF, EPIC urinary and sexual domain, AUA, EHS, EDITS and TSS questionnaires. Penile length will be measured from pubis to corona of the glans penis (dorsally) and recorded in centimeter using a standard wooden ruler.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
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.
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.
No Intervention: No Viberect
Men in this group will not be provided with the Viberect device.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718704
|Contact: Kambiz Tajkarimi, MD||1-202-321-8162||Kambiz123@hotmail.com|
|Contact: Jordan Dimitrakoff, MD, PhDfirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins Hospital||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Jordan Dimitrakoff, M.D., Ph.D. 410-502-5384 email@example.com|
|Contact: Brian Le, M.D. firstname.lastname@example.org|
|Principal Investigator: Arthur L Burnett, MD, MBA|
|Frederick Urology Specialists||Recruiting|
|Frederick, Maryland, United States, 21701|
|Contact: Kambiz Tajkarimi, MD email@example.com|
|Principal Investigator: Kambiz Tajkarimi, MD|
|Principal Investigator:||Arthur L Burnett, MD, MBA||Johns Hopkins University|