Benign prostatic hyperplasia MedDRA version: 21.1 Level: PT Classification code 10004446 Term: Benign prostatic hyperplasia System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Trade Name: Dexavit 4mg/ml
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: dexamethasone disodium phosphate
CAS Number: 55203-24-2
Other descriptive name: DEXAMETHASONE DISOD
Sponsors
Department of Radiology, Rigshospitalet, Denmark
Eligibility
Sex/Gender
Male
Inclusion 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 80 milliliters - Men with low-risk prostate cancer (T1c, Gleason score =65 years) yes F.1.3.1 Number of subjects for this age range 55
Exclusion criteria
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) - Allergy to iodinated contrast media - Renal failure (eGFR 1.6) - Contraindication to conscious sedation - Allergy to dexamethasone - Positive HIV, hepatitis B or C - Immunoinflammatory disease (except topically treated skin or respiratory diseases) - Glaucoma - Active peptic or duodenal ulcer - Systemic fungal infections - Immunosuppressive treatment - Current treatment of cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: reduction in post-procedural fever and pain with dexamethasone in patients undergoing prostatic artery embolization (PAE) for benign prostatic hyperplasia (BPH);Secondary Objective: reduction in post-procedural inflammatory response (C-reactive protein), PSA, medication use, lower urinary tract symptoms (LUTS), hospital readmission, acute urinary retention and urinary tract infections with dexamethasone in patients undergoing PAE for BPH;Primary end point(s): Co-primary endpoints: - body temperature (measured rectally) - difference in pain measured by Brief Pain Inventory - Short Form (BPI-SF) - difference in quality of life (QoL) measured by Brief Pain Inventory - Short Form (BPI-SF) ;Timepoint(s) of evaluation of this end point: - temperature - day 2 post-PAE - pain - first 5 days post-PAE - QoL - first 5 days post-PAE | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Postoperative inflammatory response markers (prostate specific antigen – PSA, C-reactive protein – CRP) • Need for postoperative medications (analgesics, antipyretics, antiemetics) • Incidence of admission to hospital • LUTS severity • Erectile function • Incidence of urinary tract infections • Incidence of side-effects to PAE • Incidence of acute urinary retention ;Timepoint(s) of evaluation of this end point: Postoperative inflammatory response markers: CRP - 2 days after PAE, PSA: 2 days, 1, 3 and 3 months post-PAE Postoperative medications: first 5 days post-PAE Incidence of admission to hospital: first 5 days post-PAE LUTS severity: measured by IPSS 5 days, 1, 3 and 6 months post-PAE Erectile function> measured by IIEF-5 1, 3 and 6 months post-PAE Urinary tract infections: first 5 days post-PAE Side-effects to PAE: first 5 days post-PAE Acute urinary retention: first 5 days post-PAE | — |
Countries
Denmark
Contacts
Public ContactDepartment of Radiology
Rigshospitalet
Outcome results
None listed