Viberect Penile Vibratory Stimulation to Enhance Recovery of Erectile Function and Urinary Continence Post-Prostatectomy

Not Applicable

Withdrawn

• Conditions: Urinary Incontinence of Non-organic Origin; Erectile Dysfunction Following Radical Prostatectomy

• Registration Number: NCT01718704
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study First Submitted: 2012-10-24
• Study First Submitted QC: 2012-10-28
• Study First Posted: 2012-10-31
• Study Start: 2013-04
• Primary Completion: 2019-03-27
• Study Completion: 2019-03-27
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-22
• Last Update Posted: 2019-05-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change in erectile function (EF)	baseline to 9 months after first device use	The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single item tool. It is scored from 1 to 4. 4 indicates attainment of full rigidity with ability to perform penetrative intercourse
change in EF	baseline to 12 months after first device use	Measurement of penile length from corona to dorsal glans penis in centimeters
change in erectile function	baseline to 6 months after first device use	The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single item tool. It is scored from 1 to 4. 4 indicates attainment of full rigidity with ability to perform penetrative intercourse

Secondary Outcome Measures

Name	Time	Method
change in urinary control	baseline to 12 months after first device use	The International Prostate Symptom Score (IPSS) Questionnaire will be administered. 7 questionnaires address urinary control with a total attainable score from 0-35. 0 = no dysfunction, 1-7 = mild dysfunction, 8 - 19 = moderate dysfunction, 20-35 = severe dysfunction. The 8th/final item addresses impact of urinary control on quality of life

Trial Locations

Locations (2)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Frederick Urology Specialists; 🇺🇸 Frederick, Maryland, United States