Overview

This trial is active, not recruiting.

Condition benign prostatic hyperplasia (bph)
Treatment prolieve® thermodilatation system
Phase phase 4
Sponsor Boston Scientific Corporation
Start date September 2005
End date December 2018
Trial size 250 participants
Trial identifier NCT00407953, 101-04-401-01, U8070

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Time to re-treatment for BPH, either with Prolieve® or alternative BPH therapy, evaluated through survival analysis
time frame: Five years

Secondary Outcomes

Measure
AUA total score
time frame: 2 weeks, 3 months, and annually for five years after treatment
peak flow rate (PFR)
time frame: 2 weeks, 3 months, and annually for five years after treatment
prostate weight
time frame: 2 weeks, 3 months, and annually for five years after treatment
quality of life
time frame: 2 weeks, 3 months, and annually for five years after treatment
impact of lower urinary trct symptoms (LUTS) on quality of life
time frame: 2 weeks, 3 months, and annually for five years after treatment
BSI
time frame: 2 weeks, 3 months, and annually for five years after treatment
sexual function
time frame: 2 weeks, 3 months, and annually for five years after treatment
pain and discomfort
time frame: 2 weeks, 3 months, and annually for five years after treatment

Eligibility Criteria

Male participants at least 50 years old.

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.

Additional Information

Official title Post-Marketing Study Using PROLIEVE® for the Treatment of Benign Prostatic Hyperplasia (BPH)
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.