Viberect Penile Vibratory Stimulation to Enhance Recovery of Erectile Function and Urinary Continence Post-Prostatectomy
Conditions
Erectile Dysfunction Following Radical Prostatectomy - Urinary Incontinence of Non-organic Origin
Conditions: official terms
Erectile Dysfunction - Urinary Incontinence
Conditions: Keywords
rehabilitation, erectile dysfunction, incontinence
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Viberect device
Type: Device
Overall Status
Recruiting
Summary
The purpose of this study is to verify 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 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 40 Years
Gender: Male
Criteria: 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.
Locations
Johns Hopkins Hospital
Baltimore, Maryland, United States
Status: Recruiting
Contact: Jordan Dimitrakoff, M.D., Ph.D. - 410-502-5384 - jdimitr1@jhmi.edu
Frederick Urology Specialists
Frederick, Maryland, United States
Status: Recruiting
Contact: Kambiz Tajkarimi, MD - kambiz123@hotmail.com
Start Date
April 2013
Completion Date
December 2013
Sponsors
Johns Hopkins University
Source
Johns Hopkins University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page