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 @ 3:27 PM
Ignite Modification Date:
2025-12-24 @ 3:27 PM
NCT ID:
NCT05116592
Eligibility Criteria:
Inclusion criteria:
* Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction
* Clinical investigator has documented in the subject's medical record that in his/her judgment the subject is a surgical candidate
* Subject is 40 to 90 years of age
* Subject has an IPSS score greater than or equal to 12 measured at the baseline visit
* Subject has medical record documentation of a maximum urinary flow rate (Qmax) less than 15ml/s
* Subject is classified as American Society of Anesthesiologists (ASA) I, II or III
Exclusion criteria:
* Subject has a life expectancy of less than 2 years
* Subject has an active infection (eg, urinary tract infection or prostatitis)
* Subject has a diagnosis of, or has received treatment for, chronic prostatitis or -chronic pelvic pain syndrome (eg, non-bacterial chronic prostatitis)
* Subject has been diagnosed with a urethral stricture or bladder neck contracture
* Subject has history of lower urinary tract surgery (eg, TURP, laser, urinary diversion, artificial urinary sphincter, penile prosthesis)
* Subject has diagnosis of stress urinary incontinence that requires treatment or daily pad/device use
* Subject has diagnosis of prostate cancer and receive cancer treatment
* Subject has a history of carcinoma in situ (CIS), Ta Grade 2, Ta Grade 3 or any T1 stage bladder cancer
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
90 Years
Study:
NCT05116592
Study Brief:
Protocol Section:
NCT05116592