Efficacy of a Single Dose Dexamethasone in Reducing the Postembolization Syndrome in Men Undergoing Prostatic Artery Embolization for Benign Prostatic Hyperplasia

Rigshospitalet, Denmark60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Prostatic Hyperplasia

Eligibility

Sex: MALEMin age: 21 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Body temperature

Mean rectal body temperature, measured in degrees Celsius

Time frame: Measured by participant on Day 2 following PAE,

Postprocedural pain

Mean postprocedural pain measured on Brief Pain Inventory Short Form (BPI-SF), score on a 0-10 scale, higher score indicates higher level of pain

Time frame: During the first 5 days following PAE

Postprocedural quality of life

Mean postprocedural quality of life measured on BPI-SF, score on a 0-10 scale, higher score indicates lower quality of life

Time frame: During the first 5 days following PAE

Secondary Outcomes

Inflammatory response markers

C-reactive protein, measured in mg/l

Time frame: Measured at baseline and 2 days following PAE

Prostate specific antigen (PSA)

PSA, measured in ng/ml

Time frame: Measured at baseline, 2 days, 1 month, 3 months, and 6 months following PAE

Need for postprocedural medication

Use of analgesics, antipyretics and antiemetics (frequency and dosage)

Time frame: During the first 5 days following PAE

Hospital admission

Incidence of hospital admission

Time frame: During the first 5 days following PAE

LUTS severity

Measured on International Prostate Symptom Score (IPSS) questionnaire, each answer is scored from 0 to 5 for a maximum score of 35 points, higher score indicates more pronounced symptoms

Time frame: Measured at baseline, 2 days, 5 days, 1 month, 3 months, and 6 months following PAE

Erectile function

Measured on International Index of Erectile Function (IIEF-5) questionnaire, each answer is scored from 1 to 5 for a maximum score of 25 points, higher score indicates more pronounced symptoms

Time frame: Measured at baseline, 1 month, 3 months, and 6 months following PAE

Prostate volume

Measured on transrectal US, in ml

Time frame: Measured at baseline, 3 and 6 months following PAE

Peak urinary flow rate (Qmax)

Qmax, measured in ml/s

Time frame: Measured at baseline, 3 and 6 months following PAE

Mean urinary flow rate (Qmean)

Qmean, measured in ml/s

Time frame: Measured at baseline, 3 and 6 months following PAE

Residual urine

Residual urine, measured in ml

Time frame: Measured at baseline, 3 and 6 months following PAE

Urinary tract infections

Incidence of urinary tract infections

Time frame: During the first 5 days following PAE

Acute urinary retention

Incidence of acute urinary retention

Time frame: During the first 5 days following PAE

Side effects of PAE

Incidence of side effects of PAE (PES excluded)

Time frame: During the first 5 days following PAE

Dysuria

Incidence of dysuria

Time frame: During the first 5 days following PAE

Nausea and vomiting

Incidence of nausea and vomiting

Time frame: During the first 5 days following PAE

Blood glucose

Self-measured fasting blood glucose in mmol/l, only in patients with diabetes

Time frame: During the first 5 days following PAE

Efficacy of a Single Dose Dexamethasone in Reducing the Postembolization Syndrome in Men Undergoing Prostatic Artery Embolization for Benign Prostatic Hyperplasia

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts