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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00407953
First received: December 1, 2006
Last updated: February 4, 2013
Last verified: February 2013

December 1, 2006
February 4, 2013
September 2005
December 2018   (final data collection date for primary outcome measure)
Time to re-treatment for BPH, either with Prolieve® or alternative BPH therapy, evaluated through survival analysis [ Time Frame: Five years ] [ Designated as safety issue: No ]
Time to re-treatment for BPH, either with Prolieve® or alternative BPH therapy, evaluated through survival analysis
Complete list of historical versions of study NCT00407953 on ClinicalTrials.gov Archive Site
  • AUA total score [ Time Frame: 2 weeks, 3 months, and annually for five years after treatment ] [ Designated as safety issue: No ]
  • peak flow rate (PFR) [ Time Frame: 2 weeks, 3 months, and annually for five years after treatment ] [ Designated as safety issue: No ]
  • prostate weight [ Time Frame: 2 weeks, 3 months, and annually for five years after treatment ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 2 weeks, 3 months, and annually for five years after treatment ] [ Designated as safety issue: No ]
  • impact of lower urinary trct symptoms (LUTS) on quality of life [ Time Frame: 2 weeks, 3 months, and annually for five years after treatment ] [ Designated as safety issue: No ]
  • BSI [ Time Frame: 2 weeks, 3 months, and annually for five years after treatment ] [ Designated as safety issue: No ]
  • sexual function [ Time Frame: 2 weeks, 3 months, and annually for five years after treatment ] [ Designated as safety issue: No ]
  • pain and discomfort [ Time Frame: 2 weeks, 3 months, and annually for five years after treatment ] [ Designated as safety issue: No ]
  • AUA total score
  • peak flow rate (PFR)
  • prostate weight
  • quality of life
  • impact of lower urinary trct symptoms (LUTS) on quality of life
  • BSI
  • sexual fnction
  • pain and discomfort
Not Provided
Not Provided
 
PROLIEVE® Post-Marketing Study TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH)
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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Benign Prostatic Hyperplasia (BPH)
Device: Prolieve® Thermodilatation System
Prolieve® is a transurethral microwave therapy device equipped with automated controls designed to deliver microwave energy to the prostate and balloon-administered compression for the treatment of symptomatic BPH.
Other Name: Prolieve®
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
250
December 2018
December 2018   (final data collection date for primary outcome measure)

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.
Male
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00407953
U8070, 101-04-401-01
No
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Study Director: Thomas Bowman, M.D. Boston Scientific Corporation
Boston Scientific Corporation
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP