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 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT02974751
Eligibility Criteria:
Inclusion Criteria:
* Male.
* Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction or in urinary retention.
* Prostate size ≥ 20 mL and ≤ 150 mL as measure by TRUS.
* Patient is mentally capable and willing to sign a study-specific informed consent form.
Exclusion Criteria:
* Patients unable to stop anticoagulants, antiplatelet agents, or non-steroidal anti-inflammatory agents (NSAIDs, including aspirin greater or equal to 100mg) prior to treatment per standard of care.
* History of gross haematuria.
* Participants using systemic immune-suppressants including corticosteroids (except inhalants), known coagulopathy, or platelet disorder (except aspirin below 100mg/d).
* Contraindication to both general and spinal anesthesia.
* Any severe illness that would prevent complete study participation or confound study results.
* Subject is unwilling to accept a transfusion should one be required.
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT02974751
Study Brief:
Protocol Section:
NCT02974751