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 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT04997369
Eligibility Criteria:
Inclusion Criteria:
* Male subject of 40 - 80 years of age
* Has provided informed consent
* Has a diagnosis of bladder outlet obstruction due to benign prostatic enlargement
* Able to complete self-administered questionnaires
* Is a surgical candidate for Rezum
* Has medical record documentation of Qmax \< 15 ml/s
* Has medical record documentation of prostate volume from 30-80 ml by transrectal ultrasound (TRUS)
* Has a bladder contractility index score ≥ 100, calculated by detrusor pressure at Qmax (pDet@qmax) + (5xQmax).
* Willing to undergo pressure-flow studies to calculate BCI prior to surgical intervention.
* Has serum creatinine within the normal range.
* Able to perform intermittent catheterization.
Exclusion Criteria:
* Has a life expectancy \< 2 years
* Is currently enrolled in or plans to enroll in any concurrent drug or device study
* Has an active infection (e.g., urinary tract infection or prostatitis)
* Has a diagnosis of or has received treatment for chronic prostatitis or chronic pelvic pain syndrome (e.g., nonbacterial chronic prostatitis)
* Has been diagnosed with a urethral stricture or bladder neck contracture within the last 180 days
* Has been diagnosed with 2 or more urethral strictures and/or bladder neck contractures within 5 years
* Has a diagnosis of lichen sclerosis
* Has a diagnosis of neurogenic bladder or other neurologic disorder that affects bladder function
* Has a diagnosis of polyneuropathy (e.g., diabetic)
* Has a history of lower urinary tract surgery
* Has a diagnosis of stress urinary incontinence that requires treatment or daily pad or device use
* Has an inability to perform intermittent self-catheterization
* Has been catheterized or has a post-void residual (PVR) of \> 400 ml in the 14 days prior to the surgical procedure
* Has a current diagnosis of bladder stones
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT04997369
Study Brief:
Protocol Section:
NCT04997369