PROLIEVE® Post-Marketing Study TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH)



Status:Recruiting
Conditions:Hematology, Urology
Therapuetic Areas:Hematology, Nephrology / Urology
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:September 2005
End Date:December 2017
Contact:Lisa LeBlanc
Email:Lisa.LeBlanc@bsci.com
Phone:508-683-6636

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


This post-marketing study is being conducted to evaluate the long-term safety and
effectiveness of the Prolieve Thermodilatation® System (Prolieve®) in the treatment of
Benign Prostatic Hyperplasia (BPH). A secondary objective is to assess the safety and
effectiveness of re-treatment with Prolieve® and determine the percent of subjects electing
to be re-treated with Prolieve® rather than alternate therapy. This study will follow
subjects treated with Prolieve® at 2 weeks, 3 months, and on a yearly basis for 5 years
after treatment. Both efficacy and safety information will be collected at all follow-up
visits. Procedural and safety information will be collected during treatment to further
substantiate the findings of the pivotal trial.


Inclusion Criteria:

- Diagnosed with symptomatic BPH

- Peak urine flow rate <12 mL/sec on voided volume of >125 mL

- AUA symptom score value >=9.

Exclusion Criteria:

- Subjects whose pain response has been significantly decreased by any means.

- Subject with a history of any illness or surgery that might confound the results of
the study "or impede 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 confirmed or suspected malignancy of the prostate

- Subject with 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 >80 g.

- Subject with previous pelvic irradiation or radial pelvic surgery

- Subject having a 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 implant or staples etc. in the pelvic/femoral area.

- 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.

- Concomitant medicating of the following:

- bladder antispasmodics within one week of treatment, unless evidenced 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.
We found this trial at
27
sites
Houston, Texas 77024
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2128 W Flagler St # 201
Miami, Florida 33144
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Miami, FL
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Missoula, Montana 59802
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80 Doctors Drive
Panama City, Florida 32405
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Panama City, FL
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Albany, NY
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Annapolis, Maryland 21401
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Annapolis, MD
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Baltimore, Maryland 21204
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Baltimore, MD
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Cheektowaga, New York 14225
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Cheektowaga, NY
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Chelmsford, Massachusetts 01824
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Chelmsford, MA
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Cinncinnatti, Ohio 45212
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Columbus, Ohio 43214
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Columbus, OH
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Concord, North Carolina 28025
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Concord, NC
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Fresno, California 93720
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Fresno, CA
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McAllen, TX
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Middlebury, Connecticut 06762
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Middlebury, CT
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Mountlake Terrace, Washington 98043
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Mountlake Terrace, WA
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New Orleans, Louisiana 70115
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New Orleans, LA
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New York, New York 10016
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Orlando, Florida 32308
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Overland Park, Kansas 66211
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Poughkeepsie, New York 12601
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Roswell, Georgia 30066
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Roswell, GA
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San Antonio, Texas 78229
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San Antonio, TX
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Shreveport, Louisiana 71106
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Shreveport, LA
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Springfield, Oregon 97477
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St. Clair Shores, Michigan 48081
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St. Clair Shores, MI
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