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:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-25 @ 2:19 AM
NCT ID:
NCT03191734
Eligibility Criteria:
Inclusion Criteria:
* Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction.
* History of inadequate response, contraindication or refusal to medical therapy for BPH.
* Age from 45 through 80 years.
* Prostate volume between 30mL and 80mL by transrectal ultrasound (TRUS) measured at baseline.
Exclusion Criteria:
* BMI ≥ 42.
* IPSS total score \<12.
* History of prostate cancer or clinically significant elevated PSA value.
* History of bladder cancer actively treated within 2 years prior to the surgical procedure.
* Bladder calculus or clinically significant bladder diverticulum (e.g., pouch size \>20% of full bladder size).
* Active infection, including urinary tract infection within 72 hours of the treatment procedure.
* Prostatitis treated with antibiotics within 1 year of the surgical procedure.
* Subject ever diagnosed with urethral stricture, meatal stenosis, or bladder neck contracture, or has history of damage to external urinary sphincter.
* Subject has current diagnosis of stress urinary incontinence that requires treatment or daily pad or device use.
* Clinically significant abnormal serum creatinine measured within 30 days of treatment.
* Maximum urinary flow rate (Qmax) \>15 mL/s or PVR \> 300 mL measured by uroflowmetry test at baseline.
* Subject has been catheterized due to retention within 14 days prior to the surgical procedure.
* Subject has a history of intermittent self-catheterization.
* Previous prostate surgery or history of other lower urinary tract surgery such as e.g. urinary diversion, artificial urinary sphincter or penile prosthesis
* Subjects on anticoagulants or antiplatelet (if medication cannot be stopped before and after procedure) or known coagulopathy (except aspirin below 100mg/d)
* Any severe illness or psychiatric condition that would prevent study completion or confound study results.
* Subject taking systemic immune-suppressants including corticosteroids; unable to withhold non- steroidal anti-inflammatory agents (NSAIDs, including aspirin) for 3-5 days prior to treatment except for low dose aspirin (e.g. less than 100mg).
* Participants using medications specifically for bladder muscle problems (e.g., irritability). Use of medications with anticholinergic or similar properties is allowable provided the patient does not have documented adverse urinary side effects from these medications.
* Participating in another investigational study that could affect responses to the study device.
* Subject is unwilling to accept a transfusion should one be required.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
45 Years
Maximum Age:
80 Years
Study:
NCT03191734
Study Brief:
Protocol Section:
NCT03191734