Prostate artery embolization Urological and Genital Diseases
Conditions
Interventions
If a person chooses to take part, they will be asked to provide informed consent and undergo a baseline assessment. The baseline assessment includes a review of their medical history and the collectio
Sponsors
University Hospitals Dorset NHS Foundation Trust
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Men > 18 years of age 2. Patients with diagnosed BPE-related LUTS 3. Moderate to severe symptoms of BPE-related LUTS
Exclusion criteria
Exclusion criteria: 1. Prior surgical BPE treatment including invasive therapy or minimally invasive surgical therapies (MISTs) in the past 12 months 2. Currently using a urinary catheter, either indwelling or intermittent self-catheterisation 3. Suspicion of clinically significant prostate cancer, defined as a Gleason score of =7, a tumour volume of =0.5cc, or the presence of extraprostatic extension 4. Arterial anatomy preventing pelvic angiography 5. Contraindication to intravascular iodinated contrast, such as allergies or severely elevated creatinine/renal failure 6. History of urethral stricture or its treatment 7. Known or suspected neurogenic bladder dysfunction 8. Uncorrected coagulopathy 9. Allergy to microsphere or glue embolic materials 10. Lacks capacity to consent to the study or comply with the requirements of the study procedures and assessments 11. Participants who are unable to read, speak, or understand English sufficiently to comply with study assessments or provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Lower urinary tract symptoms are measured using the International Prostate Symptom Score (IPSS) questionnaire at Baseline, Day 0 (Procedure), 1 Month, 3 Months, 6 Months, 1 Year, 2 Years, 3 Years, and 4 Years 2. Erectile function is measured using the International Index of Erectile Function (IIEF) questionnaire at Baseline, Day 0 (Procedure), 1 Month, 3 Months, 6 Months, 1 Year, 2 Years, 3 Years, and 4 Years 3. Ejaculatory bother is measured using the MSHQ-EjD Ejaculation Bother Score questionnaire at Baseline, Day 0 (Procedure), 1 Month, 3 Months, 6 Months, 1 Year, 2 Years, 3 Years, and 4 Years 4. Quality of life is measured using a Quality of Life questionnaire at Baseline, Day 0 (Procedure), Day 1, Day 7, 1 Month, 3 Months, 6 Months, 1 Year, 2 Years, 3 Years, and 4 Years 5. Procedural satisfaction is measured using a Procedural Satisfaction Score questionnaire at Day 7 6. Pain is measured using a Pain Score questionnaire at Day 1, Day 7, 1 Month, 3 Months, and 6 Months 7. Post-embolisation syndrome symptoms are measured using a Post Embolisation Syndrome questionnaire at Day 0 (Procedure), Day 1, Day 7, 1 Month, and 3 Months 8. Presence of urinary tract infection is measured using a questionnaire at Day 0 (Procedure), Day 1, Day 7, 1 Month, 3 Months, 6 Months, 1 Year, 2 Years, 3 Years, and 4 Years 9. Presence of catheter and time to removal are measured using a questionnaire at Day 0 (Procedure), Day 1, Day 7, 1 Month, 3 Months, 6 Months, 1 Year, 2 Years, 3 Years, and 4 Years 10. Use of additional BPE-related LUTS treatments is measured using a questionnaire at Day 0 (Procedure), 1 Month, 3 Months, 6 Months, 1 Year, 2 Years, 3 Years, and 4 Years 11. Recurrent symptoms are measured using a questionnaire at 1 Month, 3 Months, 6 Months, 1 Year, 2 Years, 3 Years, and 4 Years 12. Hospital admissions are measured using hospital records at Day 0 (Procedure), Day 1, Day 7, 1 Month, 3 Months, 6 Months, 1 Year, 2 Years, 3 Years, and 4 Years 13. | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
England, United Kingdom
Contacts
Public ContactJames Coulton
Outcome results
None listed