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 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT06817733
Eligibility Criteria:
Inclusion Criteria:
* Age 45-85 years;
* International Prostate Symptom Score (IPSS) ≥ 8, indicating moderate to severe Lower Urinary Tract Symptoms (LUTS) that significantly impact quality of life;
* Poor response to pharmacological treatment or refusal of pharmacological treatment;
* Prostate volume 30-80 mL;
* Maximum urinary flow rate (Qmax) \< 15 mL/s;
* Post-void residual urine volume (PVR) \< 300 mL;
* Willingness to provide informed consent and participate in postoperative follow-up.
Exclusion Criteria:
* Prostate volume \< 30 mL or \> 80 mL;
* Severe urinary tract infection;
* Preoperative definitive diagnosis of prostate cancer;
* Known neurogenic bladder, detrusor muscle weakness, urethral stricture, or other non-BPH causes of urinary obstruction;
* Patients with prostatitis;
* History of invasive prostate interventions, such as radiofrequency ablation, laser therapy, or microwave treatment;
* Patients with severe cardiovascular disease, chronic obstructive pulmonary disease, severe diabetes, hepatic or renal dysfunction, or systemic bleeding disorders, as assessed by the investigator to be unsuitable for surgery.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
45 Years
Maximum Age:
85 Years
Study:
NCT06817733
Study Brief:
Protocol Section:
NCT06817733