Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT02021032
Eligibility Criteria:
Inclusion Criteria:
* 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:
* 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 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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02021032
Study Brief:
Protocol Section:
NCT02021032