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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT05443451
Eligibility Criteria:
Inclusion Criteria:
* Age over 50 years.
* Benign prostatic hyperplasia with prostate size 30-80 cc
* IPSS ≥ 14
* PSA ≤ 4 ng/mL or PSA \>4 ng/mL with no evidence of suspicious lesion on mpMRI
* Maximum urine flow rate (Qmax) ≤ 15 mL/s.
* Post-Void Residual ≤ 150 mL.
* Patient suitable for IV sedation and/or spinal anaesthesia and/or general anaesthesia and focal microwave ablation.
* Informed written consent
Exclusion Criteria:
* Significant intravesical median lobe hyperplasia.
* Suspicious lesion on mpMRI prostate
* History of prostate, bladder or urethral surgery.
* History of prostate cancer
* Presence of stones, bladder diverticulum and/or bladder tumor
* History of long-term indwelling catheter.
* Urethral stricture
* Known coagulopathy or on anticoagulant
* Presence of a pacemaker.
* Active infection
* Dysuria due to bladder dysfunction.
* Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to the screening visit.
* Neurological disorders that would impact bladder function (e.g., multiple sclerosis, Parkinson's disease, spinal cord injury).
* Contraindications for mpMRI exam or MR contrast
* Acute and/or chronic renal failure (GFR \<50 ml/min and serum creatinine \> 1.5 mg/d).
* Patient currently participating in another interventional clinical trial.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Study:
NCT05443451
Study Brief:
Protocol Section:
NCT05443451