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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2022
  • participants needed
    60
  • sponsor
    Rigshospitalet, Denmark
Updated on 19 March 2021

Summary

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.

Details
Condition Benign prostatic hypertrophy, Prostatic disorder, Prostate Disorders, Benign Prostatic Hyperplasia (Enlarged Prostate), benign prostatic hyperplasia
Treatment Dexamethasone, Saline
Clinical Study IdentifierNCT04588857
SponsorRigshospitalet, Denmark
Last Modified on19 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 21 yrs?
Are you male?
Do you have any of these conditions: Prostatic disorder or Benign Prostatic Hyperplasia (Enlarged Prostate) or Prostate Disorders or Benign prostatic hypertrophy or benign prostatic hyper...?
Do you have any of these conditions: Prostatic disorder or benign prostatic hyperplasia or Benign Prostatic Hyperplasia (Enlarged Prostate) or Prostate Disorders or Benign prostatic hyper...?
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)
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