Recruiting

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

Sponsor:

Medifocus, Inc.

Code:

NCT02021032

Conditions

Benign Prostate Hyperplasia

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prolieve

Study Details

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").

Conditions

Benign Prostate Hyperplasia

Study ID

NCT02021032

Start date

Feb, 2006

Status verified date

Sep, 2015

Completion date

Aug, 2018

Anticipated

Primary completion date

Feb, 2018

Anticipated

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

250 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Prolieve

Primary outcome measure

Time to Re-Treatment [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Varada Bidargaddi

varada.bidargaddi@kentron.co

Locations

Winter Park Urology

Recruiting

Orlando, Florida, United States

Contacts

Felipe Valerio

407-992-3170 felipevalerio@wpuafl.com

Principal Investigator:

David Jablonski, MD

Winter Park Urology

Recruiting

Orlando, Florida, United States

Contacts

Lesbia Candelaria

407-422-2728 lesbiavazquez@wpuafl.com

Principal Investigator:

Gary Kalser, MD

North Fulton Urology

Recruiting

Roswell, Georgia, United States

Contacts

Elizabeth Wilson

770-752-8632 ewilson@nfurology.com

Principal Investigator:

Lewis Kriteman, MD

Regional Urology

Recruiting

Shreveport, Louisiana, United States

Contacts

Tracey Robinson

318-683-0411 trobinson@regionalurology.com

Principal Investigator:

Ralph Henderson, MD

Merrimack Urology Associates PC

Recruiting

Chelmsford, Massachusetts, United States

Contacts

Nancy Leahy, MD

978-256-9507 nleahymu@yahoo.com

Principal Investigator:

Robert Edelstein, MD

Albany Medical College Division of Urology

Recruiting

Alabany, New York, United States

Contacts

Brenda Romeo

518-262-8579 ccpurologyresearch@communitycare.com

Principal Investigator:

Ronald Kaufman, MD

Midtown Urologic Trials, PC

Recruiting

New York, New York, United States

Contacts

Carini Perello

212-686-1140 carinialmanzar@yahoo.com

Principal Investigator:

Robert Salant, MD

Mobley Research Center

Recruiting

Houston, Texas, United States

Contacts

Minna Tambourides

832-522-8312 mtambourides@tmhs.org

Principal Investigator:

David Mobley, MD

More Information

Sponsor

Medifocus, Inc.

Last update posted

Sep 24, 2015

Last verified

Sep, 2015

Keywords

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Medifocus, Inc. on 2015-09-24.