Status:
TERMINATED
JALYN for Benign Prostatic Hyperplasia (BPH) and Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Lead Sponsor:
Dr. J. Curtis Nickel
Collaborating Sponsors:
The Cleveland Clinic
University of California, Los Angeles
Conditions:
Benign Prostatic Hyperplasia
Chronic Prostatitis
Eligibility:
MALE
45+ years
Phase:
PHASE3
Brief Summary
Benign Prostatic Hyperplasia (BPH) describes a common medical condition in men over 45 associated with voiding (obstructive) and storage (irritative) lower urinary tract symptoms and is in part relate...
Detailed Description
Benign Prostatic Hyperplasia (BPH) describes a common medical condition in men over 45 associated with voiding (obstructive) and storage (irritative) lower urinary tract symptoms and is in part relate...
Eligibility Criteria
Inclusion
- Men will be eligible for the study if:
- age at least 45 years
- report symptoms of discomfort or pain in the pelvic region during at least 3 of the previous 6 months
- total score of at least 12 (out of 43) points on the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) at both a screening and randomization visit
- IPSS score of at least 8 points 5 tenderness on light palpation of the prostate
- 6\. prostate size estimated to be at least 30cc on digital rectal examination
Exclusion
- Participants are excluded if
- prior treatment with dutasteride or finasteride. Alpha blocker therapy within 3 months of randomization.
- documented urinary tract infection (\>105 colony forming units per ml of a recognized uropathogen)
- history of renal failure (or calculated creatinine clearance of \< 60 ml/min)
- symptomatic genital herpes in the last 3 months.
- unilateral orchalgia without pelvic symptoms
- a history of active urogenital cancer
- active urethral stricture.
- surgery of the lower urinary tract (not including simple diagnostic cystoscopy) in the previous 6 months (including TURP, bladder neck incision, bladder tumor resection, urethrotomy).
- History of alcohol abuse
- neurologic disease affecting voiding or the bladder
- Psychiatric condition that would make it difficult (in opinion of investigator) for patient to participate in the study
- Other acute or chronic medical condition that would make it difficult (in opinion of investigator) for patient to participate in the study
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01830829
Start Date
April 1 2013
End Date
October 1 2014
Last Update
October 22 2014
Active Locations (1)
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1
Centre for Applied Urological Research
Kingston, Ontario, Canada, K7L 3J7