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

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Trial Conditions
  • Benign Prostatic Hyperplasia (BPH)
What is the purpose of this trial?

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.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
50 and older

Gender:
Male

Eligibility

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.

Gender: Male
Steward Physician(s)
  • Thomas Bowman, M.D.
Trial Interventions
Device
  • Prolieve® Thermodilatation System
Physician Researcher

Investigator Name:

  • Thomas Bowman, M.D.

Other Information

Sponsor: Boston Scientific Corporation
Phase: Phase 4
Trial ID: NCT00407953
Volunteers:  Not Accepting Healthy Volunteers

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