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