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

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2015 by Medifocus, Inc.
Sponsor:
Information provided by (Responsible Party):
Medifocus, Inc.
ClinicalTrials.gov Identifier:
NCT02021032
First received: December 16, 2013
Last updated: September 23, 2015
Last verified: September 2015
  Purpose
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").

Condition Intervention Phase
Benign Prostate Hyperplasia Device: Prolieve Phase 4

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Medifocus, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 250
Study Start Date: February 2006
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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 >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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02021032

Contacts
Contact: Varada Bidargaddi varada.bidargaddi@kentron.co

Locations
United States, Florida
Winter Park Urology Recruiting
Orlando, Florida, United States
Contact: Felipe Valerio    407-992-3170    felipevalerio@wpuafl.com   
Principal Investigator: David Jablonski, MD         
Winter Park Urology Recruiting
Orlando, Florida, United States
Contact: Lesbia Candelaria    407-422-2728    lesbiavazquez@wpuafl.com   
Principal Investigator: Gary Kalser, MD         
United States, Georgia
North Fulton Urology Recruiting
Roswell, Georgia, United States
Contact: Elizabeth Wilson    770-752-8632    ewilson@nfurology.com   
Principal Investigator: Lewis Kriteman, MD         
United States, Louisiana
Regional Urology Recruiting
Shreveport, Louisiana, United States
Contact: Tracey Robinson    318-683-0411 ext 173    trobinson@regionalurology.com   
Principal Investigator: Ralph Henderson, MD         
United States, Massachusetts
Merrimack Urology Associates PC Recruiting
Chelmsford, Massachusetts, United States
Contact: Nancy Leahy, MD    978-256-9507    nleahymu@yahoo.com   
Principal Investigator: Robert Edelstein, MD         
United States, New York
Albany Medical College Division of Urology Recruiting
Alabany, New York, United States
Contact: Brenda Romeo    518-262-8579    ccpurologyresearch@communitycare.com   
Principal Investigator: Ronald Kaufman, MD         
Midtown Urologic Trials, PC Recruiting
New York, New York, United States
Contact: Carini Perello    212-686-1140    carinialmanzar@yahoo.com   
Principal Investigator: Robert Salant, MD         
United States, Texas
Mobley Research Center Recruiting
Houston, Texas, United States
Contact: Minna Tambourides    832-522-8312    mtambourides@tmhs.org   
Principal Investigator: David Mobley, MD         
Sponsors and Collaborators
Medifocus, Inc.
Investigators
Study Director: Perry Weiner, MD Jefferson Urology
  More Information

Responsible Party: Medifocus, Inc.
ClinicalTrials.gov Identifier: NCT02021032     History of Changes
Obsolete Identifiers: NCT00407953
Other Study ID Numbers: 101-04-401-01
Study First Received: December 16, 2013
Last Updated: September 23, 2015

Keywords provided by Medifocus, Inc.:
BPH

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male

ClinicalTrials.gov processed this record on July 27, 2017