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Clinical Trials/NCT04588857
NCT04588857
Unknown
Phase 4

Randomized Double-blind Placebo-controlled Trial on the Efficacy of a Single Dose Dexamethasone in Reducing the Postembolization Syndrome in Men Undergoing Prostatic Artery Embolization for Benign Prostatic Hyperplasia

Rigshospitalet, Denmark1 site in 1 country60 target enrollmentMarch 1, 2021

Overview

Phase
Phase 4
Intervention
Dexamethasone
Conditions
Prostatic Hyperplasia
Sponsor
Rigshospitalet, Denmark
Enrollment
60
Locations
1
Primary Endpoint
Body temperature
Last Updated
4 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
June 1, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Petra Svarc, MD

PhD student

Rigshospitalet, Denmark

Eligibility Criteria

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)

Arms & Interventions

Active drug

dexamethasone 24 mg i.v., single dose

Intervention: Dexamethasone

Placebo

saline i.v., single dose

Intervention: Saline

Outcomes

Primary Outcomes

Body temperature

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

Mean rectal body temperature, measured in degrees Celsius

Postprocedural pain

Time Frame: During the first 5 days following PAE

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

Postprocedural quality of life

Time Frame: During the first 5 days following PAE

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

Secondary Outcomes

  • Peak urinary flow rate (Qmax)(Measured at baseline, 3 and 6 months following PAE)
  • Inflammatory response markers(Measured at baseline and 2 days following PAE)
  • Prostate volume(Measured at baseline, 3 and 6 months following PAE)
  • Prostate specific antigen (PSA)(Measured at baseline, 2 days, 1 month, 3 months, and 6 months following PAE)
  • Need for postprocedural medication(During the first 5 days following PAE)
  • Hospital admission(During the first 5 days following PAE)
  • LUTS severity(Measured at baseline, 2 days, 5 days, 1 month, 3 months, and 6 months following PAE)
  • Erectile function(Measured at baseline, 1 month, 3 months, and 6 months following PAE)
  • Mean urinary flow rate (Qmean)(Measured at baseline, 3 and 6 months following PAE)
  • Residual urine(Measured at baseline, 3 and 6 months following PAE)
  • Urinary tract infections(During the first 5 days following PAE)
  • Acute urinary retention(During the first 5 days following PAE)
  • Side effects of PAE(During the first 5 days following PAE)
  • Dysuria(During the first 5 days following PAE)
  • Nausea and vomiting(During the first 5 days following PAE)
  • Blood glucose(During the first 5 days following PAE)

Study Sites (1)

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