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 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
NCT ID:
NCT04245566
Eligibility Criteria:
Inclusion Criteria:
* men ≥45 years of age
* lower urinary tract symptoms assigned to BPH (diagnosis by medical history and physical examination)
* IPSS ≥ 8 points
* QoL ≥ 3 points
* Qmax ≤ 15 ml/s with a minimum voided volume ≥ 125 ml
* informed consent for study participation
Exclusion Criteria:
* renal impairment (GFR \< 30ml/min)
* previous prostatic surgery
* 5-alpha reductase inhibitor (5-ARI) use within 6 mo (or dutasteride within 12 mo) prior to entry, or use of an α-blocker or phytotherapy for BPH within 2 weeks prior to entry
* history or evidence of prostate cancer
* absolute indication for surgical treatment of complications related to BPH (i.e. bladder stones, renal impairment due to bladder outlet obstruction)
* history of neurogenic bladder dysfunction
* not able to complete questionnaires due to cognitive or thought disorders
* language skills insufficient for informed consent and / or completion of questionnaires
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
45 Years
Maximum Age:
100 Years
Study:
NCT04245566
Study Brief:
Protocol Section:
NCT04245566