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

Primary Purpose

Benign Prostate Hyperplasia

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Prolieve
Sponsored by
Medifocus, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostate Hyperplasia focused on measuring BPH

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Winter Park UrologyRecruiting
  • Winter Park UrologyRecruiting
  • North Fulton UrologyRecruiting
  • Regional UrologyRecruiting
  • Merrimack Urology Associates PCRecruiting
  • Albany Medical College Division of UrologyRecruiting
  • Midtown Urologic Trials, PCRecruiting
  • Mobley Research CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prolieve

Arm Description

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.

Outcomes

Primary Outcome Measures

Time to Re-Treatment
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
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.

Full Information

First Posted
December 16, 2013
Last Updated
September 23, 2015
Sponsor
Medifocus, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02021032
Brief Title
Post-Marketing Study Using PROLIEVE® for the Treatment of Benign Prostatic Hyperplasia (BPH)
Official Title
Post-Marketing Study Using PROLIEVE® for the Treatment of Benign Prostatic Hyperplasia (BPH)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2006 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medifocus, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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").

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostate Hyperplasia
Keywords
BPH

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prolieve
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Prolieve
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to Re-Treatment
Description
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.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Change from Baseline in American Urological Association (AUA) Total Score at 5 years
Description
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.
Time Frame
5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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. 5-alpha reductase inhibitors and gonadotropin releasing hormonal analog. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Varada Bidargaddi
Email
varada.bidargaddi@kentron.co
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Perry Weiner, MD
Organizational Affiliation
Jefferson Urology
Official's Role
Study Director
Facility Information:
Facility Name
Winter Park Urology
City
Orlando
State/Province
Florida
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felipe Valerio
Phone
407-992-3170
Email
felipevalerio@wpuafl.com
First Name & Middle Initial & Last Name & Degree
David Jablonski, MD
Facility Name
Winter Park Urology
City
Orlando
State/Province
Florida
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lesbia Candelaria
Phone
407-422-2728
Email
lesbiavazquez@wpuafl.com
First Name & Middle Initial & Last Name & Degree
Gary Kalser, MD
Facility Name
North Fulton Urology
City
Roswell
State/Province
Georgia
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Wilson
Phone
770-752-8632
Email
ewilson@nfurology.com
First Name & Middle Initial & Last Name & Degree
Lewis Kriteman, MD
Facility Name
Regional Urology
City
Shreveport
State/Province
Louisiana
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracey Robinson
Phone
318-683-0411
Ext
173
Email
trobinson@regionalurology.com
First Name & Middle Initial & Last Name & Degree
Ralph Henderson, MD
Facility Name
Merrimack Urology Associates PC
City
Chelmsford
State/Province
Massachusetts
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Leahy, MD
Phone
978-256-9507
Email
nleahymu@yahoo.com
First Name & Middle Initial & Last Name & Degree
Robert Edelstein, MD
Facility Name
Albany Medical College Division of Urology
City
Alabany
State/Province
New York
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brenda Romeo
Phone
518-262-8579
Email
ccpurologyresearch@communitycare.com
First Name & Middle Initial & Last Name & Degree
Ronald Kaufman, MD
Facility Name
Midtown Urologic Trials, PC
City
New York
State/Province
New York
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carini Perello
Phone
212-686-1140
Email
carinialmanzar@yahoo.com
First Name & Middle Initial & Last Name & Degree
Robert Salant, MD
Facility Name
Mobley Research Center
City
Houston
State/Province
Texas
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minna Tambourides
Phone
832-522-8312
Email
mtambourides@tmhs.org
First Name & Middle Initial & Last Name & Degree
David Mobley, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
34314241
Citation
Olweny EO, Jow SL, Jow WW. Prolieve Transurethral Thermodilatation for Treatment of Symptomatic Benign Prostatic Hyperplasia: 5-Year Results from a Prospective Multicenter Trial. J Endourol. 2022 Jan;36(1):117-123. doi: 10.1089/end.2021.0240. Epub 2021 Nov 1.
Results Reference
derived

Learn more about this trial

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

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