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.


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

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01718704

Sponsor: Johns Hopkins University

Eligibility:

  • Age: minimum 40 Years maximum 70 Years
  • Gender: Male

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.

View trial on ClinicalTrials.gov