Clinical trial NCT01718704: Viberect Penile Vibratory Stimulation to Enhance Recovery of Erectile Function and Urinary Continence Post-Prostatectomy
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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Erectile Dysfunction Following Radical Prostatectomy
Urinary Incontinence of Non-organic Origin
Keywords: rehabilitation
erectile dysfunction
incontinence
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2012-10-31
Enrollment: 0
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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, preoperative prostatic specific antigen (PSA) less than 10)
* between ages 40-70
* preoperative IIEF (erectile function domain) score equal or greater than 20
* IPSS 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.

Primary outcomes:
measure: change in erectile function
timeFrame: baseline to 6 weeks after first device use
measure: change in erectile function
timeFrame: baseline to 3 months after first device use
measure: change in erectile function
timeFrame: baseline to 6 months after first device use
measure: change in erectile function
timeFrame: baseline to 9 months after first device use
measure: change in erectile function
timeFrame: baseline to 12 months after first device use
measure: change in erectile function
timeFrame: baseline to 6 weeks after first device use
measure: change in erectile function
timeFrame: baseline to 3 months after first device use
measure: change in erectile function
timeFrame: baseline to 6 months after first device use
measure: change in erectile function
timeFrame: baseline to 9 months after first device use
measure: change in erectile function
timeFrame: baseline to 12 months after first device use
measure: change in erectile function
timeFrame: baseline to 6 weeks after first device use
measure: change in erectile function
timeFrame: baseline to 3 months after first device use
measure: change in erectile function
timeFrame: baseline to 6 months after first device use
measure: change in erectile function (EF)
timeFrame: baseline to 9 months after first device use
measure: change in EF
timeFrame: baseline to 12 months after first device use
measure: change in EF
timeFrame: baseline to 6 weeks after first device use
measure: change in EF
timeFrame: baseline to 3 months after first device use
measure: change in EF
timeFrame: baseline to 6 months after first device use
measure: change in EF
timeFrame: baseline to 9 months after first device use
measure: change in EF
timeFrame: baseline to 12 months after first device use
Secondary outcomes:
measure: change in urinary control
timeFrame: baseline to 6 weeks after first device use
measure: change in urinary control
timeFrame: baseline to 3 months after first device use
measure: change in urinary control
timeFrame: baseline to 6 months after first device use
measure: change in urinary control
timeFrame: baseline to 9 months after first device use
measure: change in urinary control
timeFrame: baseline to 12 months after first device use
measure: change in urinary control
timeFrame: baseline to 6 weeks after first device use
measure: change in urinary control
timeFrame: baseline to 3 months after first device use
measure: change in urinary control
timeFrame: baseline to 6 months after first device use
measure: change in urinary control
timeFrame: baseline to 9 months after first device use
measure: change in urinary control
timeFrame: baseline to 12 months after first device use
measure: change in urinary control
timeFrame: baseline to 6 weeks after first device use
measure: change in urinary control
timeFrame: baseline to 3 months after first device use
measure: change in urinary control
timeFrame: baseline to 6 months after first device use
measure: change in urinary control
timeFrame: baseline to 9 months after first device use
measure: change in urinary control
timeFrame: baseline to 12 months after first device use
Other outcomes:
measure: change in assessment of ease and acceptability of use of the Viberect
timeFrame: 6 weeks after first device use to 3 months
measure: change in assessment of ease and acceptability of use of the Viberect
timeFrame: 6 weeks after first device use to 6 months
measure: change in assessment of ease and acceptability of use of the Viberect
timeFrame: 6 weeks after first device use to 9 months
measure: change in assessment of ease and acceptability of use of the Viberect
timeFrame: 6 weeks after first device use to 12 months
measure: change in assessment of ease and acceptability of use of the Viberect
timeFrame: baseline to 6 weeks after first device use
measure: change in assessment of ease and acceptability of use of the Viberect
timeFrame: baseline to 3 months after first device use
measure: change in assessment of ease and acceptability of use of the Viberect
timeFrame: baseline to 6 months after first device use
measure: change in assessment of ease and acceptability of use of the Viberect
timeFrame: baseline to 9 months after first device use
measure: change in assessment of ease and acceptability of use of the Viberect
timeFrame: baseline to 12 months after first device use
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Frederick
country: United States
facility: Frederick Urology Specialists
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Arthur L Burnett, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: