Post-Marketing Study Using PROLIEVE® for the Treatment of Benign Prostatic Hyperplasia (BPH)

Status unconfirmed · Phase 4

Conditions studied: Benign Prostate Hyperplasia

In brief

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").

Key facts

Study ID: NCT02021032
Run by: Medifocus, Inc.
People needed: 250
Starts: 2006-02-01
Expected to finish: 2018-08-01
Last updated by the study team: 2015-09-24

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

Diagnosed with symptomatic BPH.
Peak Urine flow rate <12 ml/sec on voided volume of >125mL.
AUA symptom score value ≥9(9).
Signed informed consent.

You may not qualify if…

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.

Where it is running

Winter Park Urology — Orlando, Florida, United States (enrolling)
Winter Park Urology — Orlando, Florida, United States (enrolling)
North Fulton Urology — Roswell, Georgia, United States (enrolling)
Regional Urology — Shreveport, Louisiana, United States (enrolling)
Merrimack Urology Associates PC — Chelmsford, Massachusetts, United States (enrolling)
Albany Medical College Division of Urology — Alabany, New York, United States (enrolling)
Midtown Urologic Trials, PC — New York, New York, United States (enrolling)
Mobley Research Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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