Recruitment

Recruitment Status
Unknown status

Inclusion Criteria

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 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 urethral stricture and/or bladder stones
Subject with bleeding disorder or liver dysfunction associated with a bleeding disorder.
...
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 urethral stricture and/or bladder stones
Subject with bleeding disorder or liver dysfunction associated with a bleeding disorder.
Subject with prostate weighing <20 or >80g.
Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease.
Subject with a history of any illness for which the Prolieve® treatment may pose additional risk to the subject.
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.
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 bladder cancer
Compromised renal function (i.e., serum creatinine levels above 1.8 mg/dL).
Active urinary tract infection.
Subject with previous pelvic irradiation or radial pelvic surgery
PSA >10 ng/mL
Alpha blockers, antidepressants, androgens, within one week of treatment.
Cardiac pacemaker or metallic implants or staples, etc. in the pelvic or femoral area.
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 a history of any illness or surgery that might confound the results of the study " or impede the successful completion of trial"
Residual bladder volume >250 mL measured by ultrasound.
Subject with full urinary retention.
Subject with the confirmed or suspected malignancy of the prostate
Subject with prostatic urethra length of <1.2 cm or >5.5 cm.
Subject interested in future fertility/fathering children.
Subject having large, obstructive middle lobe

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 Criteria

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 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 urethral stricture and/or bladder stones
Subject with bleeding disorder or liver dysfunction associated with a bleeding disorder.
...
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 urethral stricture and/or bladder stones
Subject with bleeding disorder or liver dysfunction associated with a bleeding disorder.
Subject with prostate weighing <20 or >80g.
Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease.
Subject with a history of any illness for which the Prolieve® treatment may pose additional risk to the subject.
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.
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 bladder cancer
Compromised renal function (i.e., serum creatinine levels above 1.8 mg/dL).
Active urinary tract infection.
Subject with previous pelvic irradiation or radial pelvic surgery
PSA >10 ng/mL
Alpha blockers, antidepressants, androgens, within one week of treatment.
Cardiac pacemaker or metallic implants or staples, etc. in the pelvic or femoral area.
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 a history of any illness or surgery that might confound the results of the study " or impede the successful completion of trial"
Residual bladder volume >250 mL measured by ultrasound.
Subject with full urinary retention.
Subject with the confirmed or suspected malignancy of the prostate
Subject with prostatic urethra length of <1.2 cm or >5.5 cm.
Subject interested in future fertility/fathering children.
Subject having large, obstructive middle lobe

Tracking Information

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