Post-marketing study using PROLIEVE® for the treatment of benign prostatic hyperplasia (BPH)
Sponsored by Medifocus, Inc.
The primary objective of the post-marketing study is to collect safety and effectiveness data for 5 years on subjects treated with Prolieve®. The collection of 5-year safety information will be used to evaluate the occurrence of any long-term side effects from the treatment. The collection of long-term effectiveness data on subjects treated with Prolieve® will provide information on the long-term effects of treatment and time to re- treatment (any treatment initiated for BPH since Prolieve'" treatment, including a second treatment with Prolieve").
Peak Urine flow rate <12 ml/sec on voided volume of >125mL
AUA symptom score value ≥9(9)
Signed informed consent
Subjects whose pain response has been significantly decreased by any means (because the subject's ability to detect pain is a treatment safety mechanism)
Subject with a history of any illness or surgery that might confound the results of the study " or impede the successful completion of trial"
Subject with a history of any illness for which the Prolieve® treatment may pose additional risk to the subject
Subject with the confirmed or suspected malignancy of the prostate
Subject with the confirmed or suspected bladder cancer
PSA >10 ng/mL
Subject with previous treatment to the prostate (e.g., surgery, balloon dilation, stents, laser, TUNA, or Indigo prostatectomy) and/or non-metallic urogenital implants (e.g., penile prostheses, artificial urinary sphincters)
Subject with prostate weighing <20 or >80g
Subject with previous pelvic irradiation or radial pelvic surgery
Subject having large, obstructive middle lobe
Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease.
Subject with urethral stricture and/or bladder stones
Active urinary tract infection
Subject with neurogenic bladder and/or sphincter abnormalities due to Parkinson's, multiple sclerosis, cerebrovascular accident (CVA), diabetes, or other disease process
Residual bladder volume >250 mL measured by ultrasound
Compromised renal function (i.e., serum creatinine levels above 1.8 mg/dL)
Cardiac pacemaker or metallic implants or staples, etc. in the pelvic or femoral area
Concomitant medicating of the following:
Bladder antispasmodics (Ditropan or Detrol) within one week of treatment, unless there is documented evidence that the subject has been on the same drug dose for at least three months with a stable voiding pattern. The drug dose will not be altered or discontinued for the entrance into or throughout the study
5-alpha reductase inhibitors and gonadotropin releasing hormonal analog
Alpha blockers, antidepressants, androgens, within one week of treatment
Subject interested in future fertility/fathering children
Subject with full urinary retention
Subject with bleeding disorder or liver dysfunction associated with a bleeding disorder
Subject with prostatic urethra length of <1.2 cm or >5.5 cm
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