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

Withdrawn before enrolling · Not applicable

Conditions studied: Erectile Dysfunction Following Radical Prostatectomy, Urinary Incontinence of Non-organic Origin

In brief

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.

Key facts

Study ID

NCT01718704

Run by

Johns Hopkins University

People needed

0

Starts

2013-04-01

Expected to finish

2019-03-27

Last updated by the study team

2019-05-24

Who can join

Age: 40 and older, up to 70. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Frederick Urology Specialists — Frederick, Maryland, United States

Full record on ClinicalTrials.gov

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