Post-Marketing Study Using PROLIEVE® for the Treatment of Benign Prostatic Hyperplasia (BPH)
Last updated on April 2022Recruitment
- Recruitment Status
- Unknown status
Inclusion Criteria
- Diagnosed with symptomatic BPH.
- Peak Urine flow rate <12 ml/sec on voided volume of >125mL.
- AUA symptom score value ≥9(9).
- ...
- 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
- Active urinary tract infection.
- 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 prostatic urethra length of <1.2 cm or >5.5 cm.
- ...
- Active urinary tract infection.
- 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 prostatic urethra length of <1.2 cm or >5.5 cm.
- Subject with urethral stricture and/or bladder stones
- 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 a history of any illness or surgery that might confound the results of the study " or impede the successful completion of trial"
- Alpha blockers, antidepressants, androgens, within one week of treatment.
- Residual bladder volume >250 mL measured by ultrasound.
- 5-alpha reductase inhibitors and gonadotropin releasing hormonal analog.
- 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 neurogenic bladder and/or sphincter abnormalities due to Parkinson's, multiple sclerosis, cerebrovascular accident (CVA), diabetes, or other disease process.
- Subject with full urinary retention.
- Subject interested in future fertility/fathering children.
- Subject with previous pelvic irradiation or radial pelvic surgery
- PSA >10 ng/mL
- 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.
- Subject with prostate weighing <20 or >80g.
- Subject with the confirmed or suspected bladder cancer
- Cardiac pacemaker or metallic implants or staples, etc. in the pelvic or femoral area.
- Subject having large, obstructive middle lobe
- Subject with the confirmed or suspected malignancy of the prostate
- Subject with bleeding disorder or liver dysfunction associated with a bleeding disorder.
- Compromised renal function (i.e., serum creatinine levels above 1.8 mg/dL).
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
- Diagnosed with symptomatic BPH.
- Peak Urine flow rate <12 ml/sec on voided volume of >125mL.
- AUA symptom score value ≥9(9).
- ...
- 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
- Active urinary tract infection.
- 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 prostatic urethra length of <1.2 cm or >5.5 cm.
- ...
- Active urinary tract infection.
- 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 prostatic urethra length of <1.2 cm or >5.5 cm.
- Subject with urethral stricture and/or bladder stones
- 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 a history of any illness or surgery that might confound the results of the study " or impede the successful completion of trial"
- Alpha blockers, antidepressants, androgens, within one week of treatment.
- Residual bladder volume >250 mL measured by ultrasound.
- 5-alpha reductase inhibitors and gonadotropin releasing hormonal analog.
- 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 neurogenic bladder and/or sphincter abnormalities due to Parkinson's, multiple sclerosis, cerebrovascular accident (CVA), diabetes, or other disease process.
- Subject with full urinary retention.
- Subject interested in future fertility/fathering children.
- Subject with previous pelvic irradiation or radial pelvic surgery
- PSA >10 ng/mL
- 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.
- Subject with prostate weighing <20 or >80g.
- Subject with the confirmed or suspected bladder cancer
- Cardiac pacemaker or metallic implants or staples, etc. in the pelvic or femoral area.
- Subject having large, obstructive middle lobe
- Subject with the confirmed or suspected malignancy of the prostate
- Subject with bleeding disorder or liver dysfunction associated with a bleeding disorder.
- Compromised renal function (i.e., serum creatinine levels above 1.8 mg/dL).
Tracking Information
- NCT #
- NCT02021032
- Collaborators
- Not Provided
- Investigators
- Study Director: Perry Weiner, MD Jefferson Urology