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

Conditions:Hematology, Urology
Therapuetic Areas:Hematology, Nephrology / Urology
Age Range:18 - Any
Start Date:February 2006
End Date:August 2018
Contact:Varada Bidargaddi

Use our guide to learn which trials are right for you!

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").

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

- 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

- 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

- Subject with prostatic urethra length of <1.2 cm or >5.5 cm.
We found this trial at
Houston, Texas 77024
Principal Investigator: David Mobley, MD
Phone: 832-522-8312
Houston, TX
Click here to add this to my saved trials
Alabany, New York
Principal Investigator: Ronald Kaufman, MD
Phone: 518-262-8579
Alabany, NY
Click here to add this to my saved trials
Chelmsford, Massachusetts 01824
Principal Investigator: Robert Edelstein, MD
Phone: 978-256-9507
Chelmsford, MA
Click here to add this to my saved trials
New York, New York
Principal Investigator: Robert Salant, MD
Phone: 212-686-1140
New York, NY
Click here to add this to my saved trials
Orlando, Florida 32803
Principal Investigator: Gary Kalser, MD
Phone: 407-422-2728
Orlando, FL
Click here to add this to my saved trials
Orlando, Florida 32803
Orlando, FL
Click here to add this to my saved trials
Roswell, Georgia 30066
Principal Investigator: Lewis Kriteman, MD
Phone: 770-752-8632
Roswell, GA
Click here to add this to my saved trials
Shreveport, Louisiana 71106
Principal Investigator: Ralph Henderson, MD
Phone: 318-683-0411
Shreveport, LA
Click here to add this to my saved trials