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

Phase 4

• Conditions: Prostatic Hyperplasia
• Interventions: Drug: Saline; Drug: Dexamethasone

• Registration Number: NCT04588857
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-10-02
• Study First Submitted QC: 2020-10-08
• Study First Posted: 2020-10-19
• Study Start: 2021-03-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-03-22
• Primary Completion: 2022-12-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Saline	saline i.v., single dose
Active drug	Dexamethasone	dexamethasone 24 mg i.v., single dose

Primary Outcome Measures

Name	Time	Method
Body temperature	Measured by participant on Day 2 following PAE,	Mean rectal body temperature, measured in degrees Celsius
Postprocedural pain	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	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 Outcome Measures

Name	Time	Method
Residual urine	Measured at baseline, 3 and 6 months following PAE	Residual urine, measured in ml
Inflammatory response markers	Measured at baseline and 2 days following PAE	C-reactive protein, measured in mg/l
Prostate specific antigen (PSA)	Measured at baseline, 2 days, 1 month, 3 months, and 6 months following PAE	PSA, measured in ng/ml
Need for postprocedural medication	During the first 5 days following PAE	Use of analgesics, antipyretics and antiemetics (frequency and dosage)
Hospital admission	During the first 5 days following PAE	Incidence of hospital admission
LUTS severity	Measured at baseline, 2 days, 5 days, 1 month, 3 months, and 6 months following PAE	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
Erectile function	Measured at baseline, 1 month, 3 months, and 6 months following PAE	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
Prostate volume	Measured at baseline, 3 and 6 months following PAE	Measured on transrectal US, in ml
Peak urinary flow rate (Qmax)	Measured at baseline, 3 and 6 months following PAE	Qmax, measured in ml/s
Mean urinary flow rate (Qmean)	Measured at baseline, 3 and 6 months following PAE	Qmean, measured in ml/s
Urinary tract infections	During the first 5 days following PAE	Incidence of urinary tract infections
Acute urinary retention	During the first 5 days following PAE	Incidence of acute urinary retention
Side effects of PAE	During the first 5 days following PAE	Incidence of side effects of PAE (PES excluded)
Dysuria	During the first 5 days following PAE	Incidence of dysuria
Nausea and vomiting	During the first 5 days following PAE	Incidence of nausea and vomiting
Blood glucose	During the first 5 days following PAE	Self-measured fasting blood glucose in mmol/l, only in patients with diabetes

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark