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 |
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
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