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:
NCT02566551
Eligibility Criteria:
Inclusion Criteria:
Patients evaluated in the Urology Service because of BPH, candidate to TURP.
* Signed informed consent
* Lower urinary tract symptoms (LUTS) secondary to BPH for at least 6 months prior to study AND/OR baseline IPSS Score \> 13 AND/OR acute urinary retention with impossibility to remove urinary catheter AND/OR BPH symptoms refractory to medical treatment or for whom medication is contraindicated, not tolerated or refused Prostate size of at least 50 grams measured by MRI
* Patient must meet ONE of the following criteria:
1. Baseline Prostate Specific Antigen (PSA) \<4 ng/mL (no prostate biopsy required)
2. Baseline PSA \>4 ng/mL and ≤10 ng/mL AND free PSA \> 15% of total PSA (no prostate biopsy required)
3. Baseline PSA \>4 ng/mL and ≤10 ng/mL AND free PSA \<15% of total PSA AND a negative prostate biopsy result (minimum 12 core biopsy)
4. Baseline PSA \>10 ng/mL AND a negative prostate biopsy (minimum 12 core biopsy)
Exclusion Criteria:
* Active urinary tract infection
* Patients with cystoscopy findings suspicious for bladder cancer must undergo biopsy and have a negative histopathology report to be enrolled in the study
* Biopsy proven prostate or bladder cancer
* The following patients must undergo prostate biopsy with a minimum of 12 cores and have a negative histopathology report to be enrolled in the study:
* Patients with digital rectal examination (DRE) findings suspicious for prostate cancer
* Patients with baseline PSA levels \> 10 ng/mL
* Patients with baseline PSA levels \>4 ng/mL and \< 10 ng/mL AND free PSA \< 15% of total PSA
* Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function (eg multiple sclerosis, Parkinson's disease, spinal cord injuries, etc)
* Urethral stricture, bladder neck contracture, sphincter abnormalities, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition
* Allergy to iodinated contrast agents
* Hypersensitivity to gelatin products
* Previous non-medical BPH treatment, including surgery, TURP, needle ablation, microwave or laser therapy, balloon dilation, stent implantation, or any other invasive treatment to the prostate
* Known major iliac arterial occlusive disease or any known condition that catheterization of the prostatic arteries or is a contraindication to embolization, as vasospasm, anatomical variations that imply a risk of embolization, bleeding, prostatic arteries diameter inferior to microcatheter profile, pelvic inflammatory disease
* Contraindication to magnetic resonance imaging
* History of prostatitis in the last 5 years, not totally controlled with medical treatment
* History of pelvic irradiation or radical pelvic surgery
* Coagulation disturbances not normalized by medical treatment
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Study:
NCT02566551
Study Brief:
Protocol Section:
NCT02566551