EUCTR2020-000915-53-DK
Active, not recruiting
Phase 1
Randomized double-blind placebo-controlled trial on the efficiency of a single dose dexamethasone in reducing the postembolization syndrome in men undergoing prostatic artery embolization for benign prostatic hyperplasia - DEXAPAE
Department of Radiology, Rigshospitalet, Denmark0 sites60 target enrollmentMarch 27, 2020
DrugsDexavit 4mg/ml
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Department of Radiology, Rigshospitalet, Denmark
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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 equal or over 8\)
- •\- 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 is allowed.
- •\- Indwelling catheter or intermittent catheter is allowed
- •Are the trial subjects under 18? no
Exclusion Criteria
- •EXCLUSION CRITERIA:
- •\- History of bladder cancer
- •\- Previous pelvic radiation for cancer treatment
- •\- 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
- •\- 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)
Outcomes
Primary Outcomes
Not specified
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