Embolisation of the prostatic artery in patients with symptomatic benign prostate hyperplasia: A prospective single arm cohort-study.
Recruiting
- Conditions
- 10038593benign prostate hypertrofiabenign prostate tumour
- Registration Number
- NL-OMON52683
- Lead Sponsor
- Sint Elisabeth Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
men > 40 years with urinary tract symptoms due to BPH, refractory to medical
therapy
prostate size > 50cc measured by trans-rectal US and/or CT and MRI
IPSS score>18
Qol >2
Qmax <12
Exclusion Criteria
Prostate/bladder malignancy
neurogenic bladder
detrusor failure
hyper-/hypoactive bladder
urethral strictures
dysfunction/contraction bladder neck
bladder calculi of diverticula
renal insufficiency (GFR <60ml/min)
prostatitis
interstitial cystitis
severe atherosclerosis with tortuosity of afferent arteries and/or allergy to
intravenous contrast
Patient not allowed in MRI
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess the effect (Δ IPSS) after 3 months of prostate artery embolization<br /><br>(PAE) with polyethylene glycol microspheres (PEGM) in patients with low urinary<br /><br>tract symptoms (LUTS) due to benign prostate hyperplasia (BPH). </p><br>
- Secondary Outcome Measures
Name Time Method