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 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT04529369
Eligibility Criteria:
Inclusion Criteria:
* Adult males (18-year-old and more)
* Suffering bothersome LUTS or urinary retention secondary to BPH
* Cystoscopic examination documenting the predominant middle lobe prostatic adenoma that is considered to be the primary cause of BOO.
Exclusion Criteria:
* Patients neurogenic lower urinary tract dysfunction (Neurogenic Bladder)
* Not competent to give consent and/or inability to provide answers to the questionnaire
* Patient who refuse to participate in the study
* Patients without a median lobe
* Patients who have a large prostate (more than 120 g on trans-abdominal ultrasound prostate sizing).
* Patients who have renal impairment secondary to BPH
* Patients with proven or suspicion of prostate cancer based on clinical examination and/or PSA level
* Patients with refractory hematuria secondary to BPH
* Patients with urethral strictures
* Patients with bladder cancer
* Patients with history of pelvic radiotherapy
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT04529369
Study Brief:
Protocol Section:
NCT04529369