Recruitment

Recruitment Status
Unknown status

Inclusion Criterias

AUA symptom score value ≥9(9).
Peak Urine flow rate <12 ml/sec on voided volume of >125mL.
Diagnosed with symptomatic BPH.
...
AUA symptom score value ≥9(9).
Peak Urine flow rate <12 ml/sec on voided volume of >125mL.
Diagnosed with symptomatic BPH.
Signed informed consent.

Exclusion Criterias

Subject having large, obstructive middle lobe
Subject with the confirmed or suspected bladder cancer
Alpha blockers, antidepressants, androgens, within one week of treatment.
...
Subject having large, obstructive middle lobe
Subject with the confirmed or suspected bladder cancer
Alpha blockers, antidepressants, androgens, within one week of treatment.
Subjects whose pain response has been significantly decreased by any means (because the subject's ability to detect pain is a treatment safety mechanism).
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.
Subject with the confirmed or suspected malignancy of the prostate
Compromised renal function (i.e., serum creatinine levels above 1.8 mg/dL).
Subject with a history of any illness for which the Prolieve® treatment may pose additional risk to the subject.
Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease.
Active urinary tract infection.
Residual bladder volume >250 mL measured by ultrasound.
Subject with previous pelvic irradiation or radial pelvic surgery
Cardiac pacemaker or metallic implants or staples, etc. in the pelvic or femoral area.
Subject with prostatic urethra length of <1.2 cm or >5.5 cm.
Subject with bleeding disorder or liver dysfunction associated with a bleeding disorder.
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)
PSA >10 ng/mL
5-alpha reductase inhibitors and gonadotropin releasing hormonal analog.
Subject with neurogenic bladder and/or sphincter abnormalities due to Parkinson's, multiple sclerosis, cerebrovascular accident (CVA), diabetes, or other disease process.
Subject interested in future fertility/fathering children.
Subject with full urinary retention.
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 prostate weighing <20 or >80g.
Subject with urethral stricture and/or bladder stones

Summary

Conditions
Benign Prostate Hyperplasia
Type
Interventional
Phase
Phase 4
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Inclusion Criterias

AUA symptom score value ≥9(9).
Peak Urine flow rate <12 ml/sec on voided volume of >125mL.
Diagnosed with symptomatic BPH.
...
AUA symptom score value ≥9(9).
Peak Urine flow rate <12 ml/sec on voided volume of >125mL.
Diagnosed with symptomatic BPH.
Signed informed consent.

Exclusion Criterias

Subject having large, obstructive middle lobe
Subject with the confirmed or suspected bladder cancer
Alpha blockers, antidepressants, androgens, within one week of treatment.
...
Subject having large, obstructive middle lobe
Subject with the confirmed or suspected bladder cancer
Alpha blockers, antidepressants, androgens, within one week of treatment.
Subjects whose pain response has been significantly decreased by any means (because the subject's ability to detect pain is a treatment safety mechanism).
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.
Subject with the confirmed or suspected malignancy of the prostate
Compromised renal function (i.e., serum creatinine levels above 1.8 mg/dL).
Subject with a history of any illness for which the Prolieve® treatment may pose additional risk to the subject.
Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease.
Active urinary tract infection.
Residual bladder volume >250 mL measured by ultrasound.
Subject with previous pelvic irradiation or radial pelvic surgery
Cardiac pacemaker or metallic implants or staples, etc. in the pelvic or femoral area.
Subject with prostatic urethra length of <1.2 cm or >5.5 cm.
Subject with bleeding disorder or liver dysfunction associated with a bleeding disorder.
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)
PSA >10 ng/mL
5-alpha reductase inhibitors and gonadotropin releasing hormonal analog.
Subject with neurogenic bladder and/or sphincter abnormalities due to Parkinson's, multiple sclerosis, cerebrovascular accident (CVA), diabetes, or other disease process.
Subject interested in future fertility/fathering children.
Subject with full urinary retention.
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 prostate weighing <20 or >80g.
Subject with urethral stricture and/or bladder stones

Locations

Orlando, Florida
Chelmsford, Massachusetts
Orlando, Florida
Alabany, New York
Roswell, Georgia
...
Orlando, Florida
Chelmsford, Massachusetts
Orlando, Florida
Alabany, New York
Roswell, Georgia
New York, New York
Houston, Texas
Shreveport, Louisiana

Tracking Information

NCT #
NCT02021032
Collaborators
Not Provided
Investigators
Study Director: Perry Weiner, MD Jefferson Urology