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 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT07016620
Eligibility Criteria:
Inclusion Criteria:
* Men \> 40 years old
* History of Minimally invasive BPH procedure within the last 5 years.
* IPSS \>= 12
* Prostate Volume 30 - 80 gr as assessed by CT, MRI or TRUS.
* PSA \<4 or for patients with PSA 4-10 evaluation has been performed to rule out prostate cancer using biopsy, MRI, biomarker, or surgeon judgement. Labs within 1 year of study initiation
* PVR \> 150cc or reduced flow on uroflow likely due to obstruction based on clinical judgement
* IIEF-6\>or =10 without medication
Exclusion Criteria:
* Indwelling catheter or intermittent catheterization
* History of urethral strictures
* Previous diagnosis of Prostate cancer
* Active UTI or prostatitis
* Hypoactive detrusor function
* Neurogenic bladder (secondary to stroke, Multiple Sclerosis, Parkinson's disease, Spinal cord injury)
* Ejaculatory dysfunction (retrograde ejaculation, anorgasmia or anejaculation)
* Prior traditional BPH surgery (TURP, PVP, Aquablation, HOLEP, SP)
* Presence of obstructive median lobe
* Moderate to severe or severe ED based on IIEF-6/SHIM (SHIM of 10)
* Peyronie's disease
Sex:
MALE
Minimum Age:
40 Years
Study:
NCT07016620
Study Brief:
Protocol Section:
NCT07016620