Efficacy of a Single Dose Dexamethasone in Reducing the Postembolization Syndrome in Men Undergoing Prostatic Artery Embolization for Benign Prostatic Hyperplasia
Efficacy of a Single Dose Dexamethasone in Reducing the Postembolization Syndrome in Men Undergoing Prostatic Artery Embolization for Benign Prostatic Hyperplasia
Benign prostatic hyperplasia (BPH) is a frequent cause of lower urinary tract symptoms (LUTS)
 in men. One fourth of men older than 70 have moderate to severe LUTS that impair their
 quality of life (QOL). Prostatic artery embolization (PAE) is a new minimally invasive
 technique proven effective in reducing LUTS comparable to the mainstay treatment - the
 transurethral resection of the prostate (TURP).

 The most common side effect of PAE is a collection of inflammation-related symptoms known as
 the postembolization syndrome (PES). The symptoms include pelvic pain, fever, nausea, and
 transient worsening of LUTS (painful and difficult urination). PES is a self-limiting
 condition that is treated symptomatically with painkillers and antipyretics. However, PES can
 be so severe that the patients experience high fever, shivers, dysuria and urgency mimicking
 a septicemia from the urinary tract. It is a clinical challenge to avoid exposure to
 unnecessary antibiotics treatment in those situations. A subset of patients may need
 admission to the hospital for observation, especially in case of fever. Usually, PES resolves
 within a week after PAE. Steroids have been successfully used to reduce the incidence and
 severity of PES after a number of procedures in interventional radiology. The investigators
 postulate that steroids can have a similar effect in reducing PES after PAE. In this study,
 the efficacy of single high dose postprocedural dexamethasone (DEXA) administration in
 reducing PES after PAE will be evaluated, compared to placebo.
Inclusion Criteria:

 -  Diagnosis of LUTS secondary to BPH refractory to/contraindicated for medical treatment
 or not patient preference

 -  Moderate to severe urinary symptoms on IPSS (IPSS score 8 or over)

 -  Qmax <=15ml/sec, based on flowmetry

 -  Unsuitable for TURP or refuses surgery

 -  Ability to understand and the willingness to sign an informed consent

 -  Prostate volume > 80 milliliters

 -  Men with low-risk prostate cancer (T1c, Gleason score <=6 on a maximum of 3 biopsies)
 who have LUTS due to a large BPH component are eligible

 -  Indwelling or intermittent catheter is allowed

 Exclusion Criteria:

 -  History of bladder cancer

 -  Previous pelvic radiation for cancer treatment

 -  Current bladder stones

 -  Significant bladder diverticula

 -  Current urethral strictures or bladder neck contracture

 -  Neurologic conditions such as multiple sclerosis, Parkinson's disease and other
 neurological diseases known to affect bladder function

 -  Neurogenic bladder without obstruction

 -  Active urinary tract infection at the time of intervention unless in case of regular
 catheter dependence and thought to represent colonization

 -  Documented bacterial prostatitis in the last year

 -  Severe atheromatous disease or other pathology preventing catheter-based intervention
 (as rated on CT angiography by an interventional radiologist)

 -  Allergy to iodinated contrast media

 -  Renal failure (eGFR < 30ml/min)

 -  High bleeding risk (spontaneous INR > 1.6)

 -  Contraindication to conscious sedation (if requested by participant)

 -  Allergy to dexamethasone

 -  Positive HIV, hepatitis B or C

 -  Immunological disease (except topically treated skin or respiratory diseases)

 -  Glaucoma

 -  Active peptic or duodenal ulcer

 -  Systemic fungal infections

 -  Immunosuppressive treatment (systemic)

 -  Current treatment of cancer (except low risk prostate cancer)