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

Purpose

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.

Condition	Intervention	Phase
Benign Prostatic Hyperplasia (BPH)	Device: Prolieve® Thermodilatation System	Phase 4

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Post-Marketing Study Using PROLIEVE® for the Treatment of Benign Prostatic Hyperplasia (BPH)

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	250
Study Start Date:	September 2005
Estimated Study Completion Date:	December 2018
Estimated Primary Completion Date:	December 2018 (Final data collection date for primary outcome measure)

Intervention Details:

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®

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407953

Locations

United States, Connecticut
Connecticut Clinical Research Center, LLC
Middlebury, Connecticut, United States, 06762
United States, Florida
Winter Park Urology Associates
Orlando, Florida, United States, 32308
Winter Park Urology Associates
Orlando, Florida, United States, 32806
United States, Georgia
North Fulton Urology
Roswell, Georgia, United States, 30066
United States, Kansas
Kansas City Urology Care, PA
Overland Park, Kansas, United States, 66211
United States, Louisiana
Neil Baum, MD, APMC
New Orleans, Louisiana, United States, 70115
Regional Urology
Shreveport, Louisiana, United States, 71106
United States, Maryland
Anne Arundel Urology, PA
Annapolis, Maryland, United States, 21401
Chesapeake Urology Associates
Baltimore, Maryland, United States, 21204
United States, Massachusetts
Merrimack Urology Associates, PC
Chelmsford, Massachusetts, United States, 01824
United States, Michigan
Michigan Institute of Urology
St. Clair Shores, Michigan, United States, 48081
United States, Montana
Five Valleys Urology
Missoula, Montana, United States, 59802
United States, New York
Urological Institute of Northeast New York
Albany, New York, United States, 12208
Midtown Medical Trials, PC
New York, New York, United States, 10016
United States, Ohio
The Urology Group
Cinncinnatti, Ohio, United States, 45212
Columbus Urology
Columbus, Ohio, United States, 43214
United States, Texas
Mobley Research Center
Houston, Texas, United States, 77024
Urology Associates of South Texas,PA
McAllen, Texas, United States, 78503
Urology San Antonio Research
San Antonio, Texas, United States, 78229
United States, Washington
Urology Northwest/Integrity Medical Research, LLC
Mountlake Terrace, Washington, United States, 98043

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

Study Director:

Thomas Bowman, M.D.

Boston Scientific Corporation

More Information

No publications provided

Responsible Party:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00407953 History of Changes
Other Study ID Numbers:	U8070, 101-04-401-01
Study First Received:	December 1, 2006
Last Updated:	February 4, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:

prostate
BPH
Prolieve
AUA
hyperthermia

thermodilatation
benign hyperplastic hyperplasia
urology
microwave therapy
TUMT

Additional relevant MeSH terms:

Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013