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

September 23, 2015 updated by: Medifocus, Inc.
The primary objective of the post-marketing study is to collect safety and effectiveness data for 5 years on subjects treated with Prolieve®. The collection of 5-year safety information will be used to evaluate the occurrence of any long-term side effects from the treatment. The collection of long-term effectiveness data on subjects treated with Prolieve® will provide information on the long-term effects of treatment and time to re- treatment (any treatment initiated for BPH since Prolieve'" treatment, including a second treatment with Prolieve").

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States
        • Recruiting
        • Winter Park Urology
        • Contact:
        • Principal Investigator:
          • Gary Kalser, MD
    • Georgia
      • Roswell, Georgia, United States
        • Recruiting
        • North Fulton Urology
        • Contact:
        • Principal Investigator:
          • Lewis Kriteman, MD
    • Louisiana
      • Shreveport, Louisiana, United States
        • Recruiting
        • Regional Urology
        • Contact:
        • Principal Investigator:
          • Ralph Henderson, MD
    • Massachusetts
      • Chelmsford, Massachusetts, United States
        • Recruiting
        • Merrimack Urology Associates PC
        • Contact:
        • Principal Investigator:
          • Robert Edelstein, MD
    • New York
      • Alabany, New York, United States
        • Recruiting
        • Albany Medical College Division of Urology
        • Contact:
        • Principal Investigator:
          • Ronald Kaufman, MD
      • New York, New York, United States
        • Recruiting
        • Midtown Urologic Trials, PC
        • Contact:
        • Principal Investigator:
          • Robert Salant, MD
    • Texas
      • Houston, Texas, United States
        • Recruiting
        • Mobley Research Center
        • Contact:
        • Principal Investigator:
          • David Mobley, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Diagnosed with symptomatic BPH.
  • Peak Urine flow rate <12 ml/sec on voided volume of >125mL.
  • AUA symptom score value ≥9(9).
  • Signed informed consent.

Exclusion Criteria:

  • Subjects whose pain response has been significantly decreased by any means (because the subject's ability to detect pain is a treatment safety mechanism).
  • Subject with a history of any illness or surgery that might confound the results of the study " or impede the 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 the confirmed or suspected malignancy of the prostate
  • Subject with the 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 >80g.
  • Subject with previous pelvic irradiation or radial pelvic surgery
  • Subject having 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 implants or staples, etc. in the pelvic or femoral area.

  • Concomitant medicating of the following:

    1. Bladder antispasmodics (Ditropan or Detrol) within one week of treatment, unless there is documented evidence 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.
    2. 5-alpha reductase inhibitors and gonadotropin releasing hormonal analog.
    3. Alpha blockers, antidepressants, androgens, within one week of treatment.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Prolieve
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. This device utilizes a transurethral catheter with microwave antenna to heat the prostate, with simultaneous 46 Fr. prostatic urethral catheter balloon-administered compression.
Device: Prolieve
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. This device utilizes a transurethral catheter with microwave antenna to heat the prostate, with simultaneous 46 Fr. prostatic urethral catheter balloon-administered compression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Re-Treatment
Time Frame: 5 years
Time to re-treatment will be estimated using Kaplan Meier estimation techniques. The re-treatment rate at years 1 through 5 will be estimated and 95% confidence intervals obtained, and the median time to re-treatment will be estimated. Subjects who receive re-treatment will be classed as treatment failures. Subjects who are lost to follow-up will be considered as re-treated at their last known study visit. In addition, a missing at random (MAR) analysis will be performed.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in American Urological Association (AUA) Total Score at 5 years
Time Frame: 5 years
Measured based on the number of subjects who worsened, had no change (1-29%), had a 30% or greater improvement or who are missing, based on the change in AUA total score compared to individual baseline for each follow-up evaluation. A responder analysis will also be done on peak flow rate (PFR) with the following categories: the number of subjects who worsened, had no change (1-19%), had a 20% or greater improvement or who are missing, based on the change in PFR compared to individual baseline for each follow-up evaluation.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medifocus, Inc.

Investigators

  • Study Director: Perry Weiner, MD, Jefferson Urology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (ANTICIPATED)

February 1, 2018

Study Completion (ANTICIPATED)

August 1, 2018

Study Registration Dates

First Submitted

December 16, 2013

First Submitted That Met QC Criteria

December 19, 2013

First Posted (ESTIMATE)

December 27, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 24, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101-04-401-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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