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 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT05148156
Eligibility Criteria:
Inclusion Criteria:
* Subject is 50 - 99 years of age
* Subject has provided informed consent
* Subject has diagnosis of prostate cancer requiring SBRT
* Subject is able to complete self-administered questionnaires
* Subject is a surgical candidate for Urolift
* Subject has a diagnosis of BPH
* Medical record documentation of prostate volume from 30-80 ml by TRUS
* Absence of a middle lobe
Exclusion Criteria:
* Life expectancy \< 2 years
* Currently enrolled in or plans to enroll in any concurrent drug or device study
* Concurrent androgen deprivation therapy
* Has an active infection (e.g., urinary tract infection or prostatitis)
* Diagnosis of or has received treatment for chronic prostatitis or chronic pelvic pain syndrome (e.g., nonbacterial chronic prostatitis)
* Subject has been diagnosed with a urethral stricture or bladder neck contracture within the last 180 days
* Subject has been diagnosed with 2 or more urethral strictures and/or bladder neck contractures within 5 years
* Diagnosis of lichen sclerosis
* Neurogenic bladder or other neurologic disorder that affects bladder function
* Diagnosis of polyneuropathy (e.g., diabetic)
* History of lower urinary tract surgery
* Subject has diagnosis of stress urinary incontinence that requires treatment or daily pad or device use
* Subject has been catheterized or has a PVR \> 400 ml in the 14 days prior to the surgical procedure
* Current diagnosis of bladder stones
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
50 Years
Maximum Age:
99 Years
Study:
NCT05148156
Study Brief:
Protocol Section:
NCT05148156