Viberect Penile Vibratory Stimulation to Enhance Recovery of Erectile Function and Urinary Continence Post-Prostatectomy
Launched by JOHNS HOPKINS UNIVERSITY · Oct 28, 2012
Trial Information
Current as of April 28, 2025
Withdrawn
Keywords
ClinConnect Summary
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...
Gender
MALE
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.
About Johns Hopkins University
Johns Hopkins University, a prestigious research institution located in Baltimore, Maryland, is renowned for its commitment to advancing medical science and public health through innovative clinical trials. With a rich history of groundbreaking research and a multidisciplinary approach, the university's clinical trial initiatives focus on translating scientific discoveries into effective treatments and interventions. Leveraging state-of-the-art facilities and a collaborative network of experts, Johns Hopkins University conducts rigorous clinical studies that aim to improve patient outcomes and address critical health challenges. Its dedication to ethical standards and participant safety underscores its role as a leader in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Baltimore, Maryland, United States
Frederick, Maryland, United States
Patients applied
Trial Officials
Arthur L Burnett, MD, MBA
Principal Investigator
Johns Hopkins University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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