Clinical Trials


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

Eligibility:
Ages Eligible for Study: 40 Years to 70 Years Genders Eligible for Study: Male Accepts Healthy Volunteers: No 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, PSA less than 10) between ages 40-70 preoperative IIEF (erectile function section) score equal or greater than 20 AUA symptom score 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.

Overview:
Primary Outcome Measures: Recovery of erectile function following radical prostatectomy. [ Time Frame: 12 months post-radical prostatectomy ] [ Designated as safety issue: No ] Patients will visit with investigators. Physical examination will be performed, including genital exam for any signs of penile irritation. Study subjects will complete the IIEF, EPIC urinary and sexual domain, AUA, EHS, EDITS and TSS questionnaires. Penile length will be measured from pubis to corona of the glans penis (dorsally) and recorded in centimeter using a standard wooden ruler. Secondary Outcome Measures: Recovery of continence after radical prostatectomy [ Time Frame: 12 months post-prostatectomy ] [ Designated as safety issue: No ] Patients will visit with investigators. Physical examination will be performed, including genital exam for any signs of penile irritation. Study subjects will complete the IIEF, EPIC urinary and sexual domain, AUA, EHS, EDITS and TSS questionnaires. Penile length will be measured from pubis to corona of the glans penis (dorsally) and recorded in centimeter using a standard wooden ruler.

PI: Arthur L Burnett, MD, MBA

Contact Name: Robert L Segal, MD
Phone: 410-614-0241
Email: rsegal3@jhmi.edu


Assessment of Penile Vibratory Stimulation Using the Viberect in Men With Mild-Moderate and No Erectile Dysfunction

Eligibility:
Ages Eligible for Study: 30 Years to 60 Years Genders Eligible for Study: Male Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria mild-moderate erectile dysfunction-IIEF-EF score 13-25 no erectile dysfunction-IIEF-EF score equal or greater than 25 Exclusion Criteria Men with neurological disease IIEF score less than 13 Spinal cord injury History of priapism Pelvic neuropathy Post-prostatectomy Penile skin lesions or ulcers Inability to understand and demonstrate device use instructions

Overview:
Primary Outcome Measures: To assess daily or on-demand ease of use, and efficacy of the home use of the Viberect device by men with mild to moderate and no erectile dysfunction [ Time Frame: 4 weeks after initiation of intervention ] [ Designated as safety issue: No ] After obtaining informed consent, the subjects will be instructed in the use of the Viberect device, and will be asked to perform vibratory stimulation of the penis in the privacy of their home, while focused on sexual/erotic thoughts for approximately 7-10 minutes (depending on erectile response) for 3 times a week, one day apart, throughout the four week period. Men can perform the stimulation once daily, as long as each session is more than 24 hours apart. Men will record device use and intercourse attempts after device use in a diary. They will fill out several validated questionnaires on week 4: Erection Hardness Scale (EHS), EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction), TSS questionnaire Secondary Outcome Measures: To assess safety of using Viberect penile stiumulation for the treatment of mild-moderate ED [ Time Frame: 4 weeks after initiation of intervention ] [ Designated as safety issue: Yes ] After obtaining informed consent, the subjects will be instructed in the use of the Viberect device, and will be asked to perform vibratory stimulation of the penis in the privacy of their home, while focused on sexual/erotic thoughts for approximately 7-10 minutes (depending on erectile response) for 3 times a week, one day apart, throughout the four week period. Men can perform the stimulation once daily, as long as each session is more than 24 hours apart. Men will record device use and intercourse attempts after device use in a diary. They will fill out several validated questionnaires on week 4: Erection Hardness Scale (EHS), EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction), TSS questionnaire

PI: Arthur L Burnett, MD, MBA

Contact Name: Brian Le, MD
Phone: 410-614-0241
Email: ble6@jhmi.edu


Erythropoietin to Enhance Erection Recovery in Men Following Radical Prostatectomy

Eligibility:
To be eligible for this study you must: •Be between the ages of 40 and 59 •Have localized prostate cancer •Be scheduled to have a bilateral nerve sparing radical prostatectomy at Johns Hopkins Hospital •Have intact erectile function •Have a sexual partner of at least 6 months

Overview:
This study will evaluate the effectiveness of erythropoietin versus placebo in the recovery of erectile function in patients undergoing bilateral nerve-sparing radical retropubic prostatectomy for prostate cancer. Recent laboratory findings suggest, that erythropoietin may play a role in protection of the cavernous nerves during surgery. Some degree of nerve trauma occurs during bilateral nerve-sparing radical prostatectomy, but for most it is temporary. Erythropoietin will be studied as an investigational drug for enhancement of erectile function postoperatively.

PI: Arthur L. Burnett, M.D.

Contact Name: Irene Trueheart, R.N.
Phone: (443) 287-1011
Email: itruehe1@jhmi.edu


Mirabegron For Erectile Dysfunction

Eligibility:
Ages Eligible for Study: 18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:
•presence of mild ED (IIEF EF domain score 22-25), mild to moderate ED (IIEF EF domain score 17-21) or moderate ED (IIEF EF domain score 11-16)
•presence of OAB symptoms for at least 3 months
•at least 3 micturitions per day
•at least 3 episodes of urgency in a 3 day period

Exclusion Criteria:
•history of pelvic surgery
•concurrent ED therapy
•history of penile surgery
•history of priapism (unwanted, prolonged painful erection)
•history of neurologic disease
•uncontrolled hypertension: systolic blood pressure (BP) > 140 mmHg or diastolic BP > 90 mmHg
•Stage 4 or 5 chronic kidney disease, Creatinine clearance rate < 30ml/min •moderate or severe hepatic impairment
•concomitant use of CYP2D6-metabolized drugs or digoxin
•post void residual greater than 150 ml
•evidence of urinary tract infection on urinalysis and/or urine culture


Overview:
The only class of oral erectile dysfunction (ED) medication on the market are the phosphodiesterase Type 5 inhibitors (PDE5i). This pilot study is being done to evaluate the effect of Mirabegron, an oral beta-3 adrenergic agonist, on men with both Overactive Bladder (OAB) symptoms and mild to moderate ED.

PI: Arthur L Burnett, M.D., M.B.A

Contact Name: Angela Koomson
Phone: 410-502-6407
Email: akoomso1@jhmi.edu