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.
40 Years
70 Years
Male
Erectile Dysfunction Following Radical Prostatectomy, Urinary Incontinence of Non-organic Origin
Trial Information
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.
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Recovery of erectile function following radical prostatectomy.
Outcome Description:
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.
Outcome Time Frame:
12 months post-radical prostatectomy
Safety Issue:
No
Principal Investigator
Arthur L Burnett, MD, MBA
Investigator Role:
Principal Investigator
Investigator Affiliation:
Johns Hopkins University
Authority:
United States: Institutional Review Board
Study ID:
NA_00069795
NCT ID:
NCT01718704
Start Date:
April 2013
Completion Date:
December 2013
Related Keywords:
- Erectile Dysfunction Following Radical Prostatectomy
- Urinary Incontinence of Non-organic Origin
- rehabilitation
- erectile dysfunction
- incontinence
- Urinary Incontinence
- Erectile Dysfunction
Name | Location |
|---|---|
| Johns Hopkins Hospital | Baltimore, Maryland 21287 |
| Frederick Urology Specialists | Frederick, Maryland 21701 |
