Clinical trial NCT02021032: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Benign Prostate Hyperplasia
Keywords: BPH
Lead sponsor: Medifocus, Inc.
Sponsor class: INDUSTRY
First posted: 2013-12-27
Enrollment: 250
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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").


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:

  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.

Primary outcomes:
measure: Time to Re-Treatment
timeFrame: 5 years
Secondary outcomes:
measure: Change from Baseline in American Urological Association (AUA) Total Score at 5 years
timeFrame: 5 years
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Winter Park Urology
state: Florida
city: Orlando
country: United States
facility: Winter Park Urology
state: Florida
city: Roswell
country: United States
facility: North Fulton Urology
state: Georgia
city: Shreveport
country: United States
facility: Regional Urology
state: Louisiana
city: Chelmsford
country: United States
facility: Merrimack Urology Associates PC
state: Massachusetts
city: Alabany
country: United States
facility: Albany Medical College Division of Urology
state: New York
city: New York
country: United States
facility: Midtown Urologic Trials, PC
state: New York
city: Houston
country: United States
facility: Mobley Research Center
state: Texas
Study officials:
affiliation: Jefferson Urology
name: Perry Weiner, MD
role: STUDY_DIRECTOR
References:
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.