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:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT06091618
Eligibility Criteria:
Inclusion criteria:
* Age \>45 years old, clinical diagnosis of BOO by medical history and physical examination (including digital rectal examination)
* International prostate symptoms score (IPSS) \>14 points
* Normal PSA (PSA\<4 ng / ml or free/ total PSA \>0.25)
* Prostate size \< 80 gm
* Men with recurrent urinary retention (drug-refractory), urinary infection, or haematuria who had failed standard medical therapy (alpha-blockers, 5-alpha reductive inhibitors)
* Patients were also required to have an active and healthy sexual life, the ability to ejaculate and a desire to preserve ejaculation
Exclusion criteria
* Major psychiatric and somatic diseases and the use of drugs that affect sexual function
* Patients with ejaculatory dysfunction or no ejaculation
* Patients with documented or suspected prostate cancer
* Patients with neurogenic bladder, voiding dysfunction, urethral strictures, and malignancies of the upper or lower urinary tract,
* Prostates sized more than 80 CC, severe comorbidities or high surgical risk patients.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
45 Years
Study:
NCT06091618
Study Brief:
Protocol Section:
NCT06091618