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

This study is currently recruiting participants.
Verified September 2015 by Medifocus, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02021032
First Posted: December 27, 2013
Last Update Posted: September 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Medifocus, Inc.
December 16, 2013
December 27, 2013
September 24, 2015
February 2006
February 2018   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02021032 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Post-Marketing Study Using PROLIEVE® for the Treatment of Benign Prostatic Hyperplasia (BPH)
Post-Marketing Study Using PROLIEVE® for the Treatment of Benign Prostatic Hyperplasia (BPH)
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").
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Benign Prostate Hyperplasia
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.
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.
Intervention: Device: Prolieve
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
August 2018
February 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 >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.
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact: Varada Bidargaddi varada.bidargaddi@kentron.co
United States
 
 
NCT02021032
101-04-401-01
No
Not Provided
Not Provided
Medifocus, Inc.
Medifocus, Inc.
Not Provided
Study Director: Perry Weiner, MD Jefferson Urology
Medifocus, Inc.
September 2015

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