Post-Marketing Study Using PROLIEVE® for the Treatment of Benign Prostatic Hyperplasia (BPH)
NCT ID: NCT02021032
Last Updated: 2015-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
250 participants
INTERVENTIONAL
2006-02-28
2018-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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
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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.
Eligibility Criteria
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Inclusion Criteria
* Peak Urine flow rate \<12 ml/sec on voided volume of \>125mL.
* AUA symptom score value ≥9(9).
* Signed informed consent.
Exclusion Criteria
* 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.
18 Years
MALE
No
Sponsors
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Medifocus, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Perry Weiner, MD
Role: STUDY_DIRECTOR
Jefferson Urology
Locations
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Winter Park Urology
Orlando, Florida, United States
Winter Park Urology
Orlando, Florida, United States
North Fulton Urology
Roswell, Georgia, United States
Regional Urology
Shreveport, Louisiana, United States
Merrimack Urology Associates PC
Chelmsford, Massachusetts, United States
Albany Medical College Division of Urology
Alabany, New York, United States
Midtown Urologic Trials, PC
New York, New York, United States
Mobley Research Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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101-04-401-01
Identifier Type: -
Identifier Source: org_study_id
NCT00407953
Identifier Type: -
Identifier Source: nct_alias
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