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

Benign Prostatic Hyperplasia (BPH) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00407953
• Other study ID #: U8070
• Secondary ID: 101-04-401-01
• Status: Active, not recruiting
• Phase: Phase 4
• First received: December 1, 2006
• Last updated: February 4, 2013
• Start date: September 2005
• Est. completion date: December 2018

Study information

• Verified date: February 2013
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia (BPH)
• Hyperplasia
• Prostatic Hyperplasia

Intervention

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.

Locations

Country	Name	City	State
United States	Urological Institute of Northeast New York	Albany	New York
United States	Anne Arundel Urology, PA	Annapolis	Maryland
United States	Chesapeake Urology Associates	Baltimore	Maryland
United States	Merrimack Urology Associates, PC	Chelmsford	Massachusetts
United States	The Urology Group	Cinncinnatti	Ohio
United States	Columbus Urology	Columbus	Ohio
United States	Mobley Research Center	Houston	Texas
United States	Urology Associates of South Texas,PA	McAllen	Texas
United States	Connecticut Clinical Research Center, LLC	Middlebury	Connecticut
United States	Five Valleys Urology	Missoula	Montana
United States	Urology Northwest/Integrity Medical Research, LLC	Mountlake Terrace	Washington
United States	Neil Baum, MD, APMC	New Orleans	Louisiana
United States	Midtown Medical Trials, PC	New York	New York
United States	Winter Park Urology Associates	Orlando	Florida
United States	Winter Park Urology Associates	Orlando	Florida
United States	Kansas City Urology Care, PA	Overland Park	Kansas
United States	North Fulton Urology	Roswell	Georgia
United States	Urology San Antonio Research	San Antonio	Texas
United States	Regional Urology	Shreveport	Louisiana
United States	Michigan Institute of Urology	St. Clair Shores	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to re-treatment for BPH, either with Prolieve® or alternative BPH therapy, evaluated through survival analysis		Five years	No
Secondary	AUA total score		2 weeks, 3 months, and annually for five years after treatment	No
Secondary	peak flow rate (PFR)		2 weeks, 3 months, and annually for five years after treatment	No
Secondary	prostate weight		2 weeks, 3 months, and annually for five years after treatment	No
Secondary	quality of life		2 weeks, 3 months, and annually for five years after treatment	No
Secondary	impact of lower urinary trct symptoms (LUTS) on quality of life		2 weeks, 3 months, and annually for five years after treatment	No
Secondary	BSI		2 weeks, 3 months, and annually for five years after treatment	No
Secondary	sexual function		2 weeks, 3 months, and annually for five years after treatment	No
Secondary	pain and discomfort		2 weeks, 3 months, and annually for five years after treatment	No