Research
Print page Print page
Switch language
The Capital Region of Denmark - a part of Copenhagen University Hospital
Published

Efficacy of dexamethasone in reducing the postembolisation syndrome in men undergoing prostatic artery embolisation for benign prostatic hyperplasia: protocol for a single-centre, randomised, double-blind, placebo-controlled trial-the 'DEXAPAE' study

Research output: Contribution to journalJournal articleResearchpeer-review

  1. Inhaled anti-asthma therapies following hormone therapy in women: a nationwide cohort study

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Mucosal cryobiopsies: a new method for studying airway pathology in asthma

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Prognostic factors for work disability in patients with chronic widespread pain and fibromyalgia: protocol for a cohort study

    Research output: Contribution to journalJournal articleResearchpeer-review

  1. Risk of recurrence and long-term mortality following radical cystectomy for bladder cancer

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Prescription rates for commonly used drugs before and after a prostate cancer diagnosis

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Pressure Difference Estimation in Non-stenotic Carotid Bifurcation Phantoms Using Vector Flow Imaging

    Research output: Contribution to journalJournal articleResearchpeer-review

  4. Selective arterial embolization of renal angiomyolipomas: A 10-year experience

    Research output: Contribution to journalJournal articleResearchpeer-review

View graph of relations

INTRODUCTION: Postembolisation syndrome (PES) is the most common side effect of vascular embolisation of solid organs. Although prophylactic corticosteroids are known to reduce the incidence and severity of PES, no trials investigating their efficacy have been conducted in men undergoing prostatic artery embolisation (PAE). We postulate that steroids can have a similar effect in reducing PES after PAE. This paper describes the rationale and detailed protocol for a randomised controlled trial evaluating the efficacy of dexamethasone (DEXA) in reducing PES after PAE.

METHODS AND ANALYSIS: In this single-centre, randomised, double-blind, placebo-controlled trial, we will enrol 60 individuals undergoing PAE for benign prostatic hyperplasia. Participants will be randomised to receive IV DEXA (24 mg) or placebo (saline). The primary outcomes will be postprocedural fever, pain and quality of life. The secondary outcomes will include postprocedural nausea, postprocedural medicine usage, laboratory parameters (C reactive protein, prostate-specific antigen) and early PAE results.

ETHICS AND DISSEMINATION: Ethics approval was obtained from the Danish Committee on Health Research Ethics in the Capital Region (H-20025910). The results from this trial will be disseminated through publication in peer-reviewed journals and national and international presentations.

TRIAL REGISTRATION NUMBER: Clinicaltrials.gov identifier: NCT04588857; EudraCT number: 2020-000915-53.

Original languageEnglish
Article numbere047878
JournalBMJ Open
Volume11
Issue number11
Pages (from-to)e047878
ISSN2044-6055
DOIs
Publication statusPublished - 1 Nov 2021

Bibliographical note

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

    Research areas

  • Arteries, Dexamethasone/therapeutic use, Double-Blind Method, Humans, Male, Prostate, Prostatic Hyperplasia/therapy, Quality of Life, Randomized Controlled Trials as Topic, Treatment Outcome

ID: 69808670