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 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT01500057
Eligibility Criteria:
Inclusion Criteria:
* male over the age of 18 years
* present with symptomatic/ obstructive symptoms secondary to PBH requiring surgical intervention
* subjects must read, understand and sign the Informed Consent
* AUA ≥ 15
* Qmax \< 15mL/sec
* Stopped BPH medication. Alpha blockers 15 days 5-α-reductase 3 months
* Prostate volume ≥ 30g
Exclusion Criteria:
* PVR \> 300ml
* Current urine retention
* Previous surgical or invasive treatments (TURP, TUMT, TUNA)
* PSA ≥ 4 (must have negative biopsy within last 12 months)
* Neurogenic bladder
* Obstruction due to urethral stricture
* Any disorder or condition of the subject that the investigator believes will counter indicate their inclusion in the study
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01500057
Study Brief:
Protocol Section:
NCT01500057