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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT00169767
Eligibility Criteria:
Inclusion Criteria:
* Ability to give informed consent
* Lower urinary tract symptoms (LUTS) felt to be secondary to bladder outlet obstruction from benign prostatic hyperplasia
* Maximum urinary flow rate \< 15 ml/sec, voided volume ≥ 125 cc
* American Urological Association symptom score ≥ 9
* Transrectal ultrasound determined prostate volume ≤ 60 cc
Exclusion Criteria:
* Inability to give informed consent
* Maximum urinary flow rate ≥ 15 ml/sec
* Transrectal ultrasound determined prostate volume \> 60cc
* AUA symptom score \< 9
* Active urinary tract infection
* Bleeding diathesis
* Neurological disease that is felt to affect the bladder or a history of a neurogenic or chronically decompensated bladder
* Known prostate cancer
* Active bladder cancer (within the last 2 years)
* Prostate specific antigen (PSA) \> 4.0 unless previous negative biopsy
* Urinary retention
* Post-void residual (PVR) \> 300 cc
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00169767
Study Brief:
Protocol Section:
NCT00169767