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 @ 9:25 PM
Ignite Modification Date:
2025-12-24 @ 9:25 PM
NCT ID:
NCT05401032
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent;
* Male patients with BPH for which tamsulosin is the therapeutic option per SoC;
* Aged ≥50 and less than 75 years old;
* With prostate volume ≥30 cm3 by TRUS;
* Diagnosed with LUTS defined by a stable IPSS total score ≥13 points.
Exclusion Criteria:
* Patients with post-void bladder residual volume ≥250 ml;
* Patients with intravesical obstruction from any cause other than BPH;
* History of any procedure considered an intervention for BPH;
* Patients with active urinary tract infection;
* History of recurrent urinary tract infections;
* Current prostatitis or diagnosis of chronic prostatitis;
* History of prostate or invasive bladder cancer;
* Use of 5 α-reductase inhibitors within 6 months;
* Phytotherapy within 2 weeks before entry;
* Use of serotonin reuptake inhibitors or monoamine oxidase inhibitors;
* Patients with acute or chronic kidney failure;
* Patients with diagnosed or suspicion of intolerance to lactose;
* Patients submitted to general anesthesia in the past 4 weeks;
* Known intellectual disability that may hampers giving informed consent and would make the patient inappropriate for entry into this study, in the judgment of the investigator.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Maximum Age:
74 Years
Study:
NCT05401032
Study Brief:
Protocol Section:
NCT05401032