PAE results in significant IPSS reduction
ID
Source
Brief title
Health condition
benign prostate hyperplasia, BPH.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Objectify reduction IPSS 3 months after PAE, with PEGM, in patients with LUTS due to BPH.
Secondary outcome
Objectify safety, defined as side effect; Expected side effects: 1. pelvic pain 2. progressive complaints of direct obstructive/irritrative symptoms 3. extension of inflammatory effect to adjecents symptoms 4. transient increased urinary frequency 5. burning urethral pain. Unexpected side effects: 1. Vascular complications 2. non-targeted embolisation 3. erectile dysfunction 4. incontinence 5. Retrograde ejaculation 6. urinarytract infection 7. bladder necrosis 8. (acute) urinary retention 9. hematuria 10. rectarrhagia 11. hematospermia 12. radiodermatitis 13. skincancer.
Background summary
Prostate embolization for patients with symptomatic benign prostate hyperplasia: a prospective, single arm cohort study.
Study objective
PAE results in significant IPSS reduction
Study design
* 2 week before inclusion (out-patient clinic) * Inclusion (out-patient clinic) * PAE in hospital * + 1wk post-procedural (consult by phone) * + 3mnd post-procedural (out-patient clinic) * + 6mnd post-procedural (out-patient clinic) * + 12mnd post-procedural (out-patient clinic)
Intervention
PAE, prostate artery
Inclusion criteria
men > 40 years, with LUTS due to BPH, refrectory to medical therapy, Size > 50cc, IPSS > 18, Qol>2, Qmax<12.
Exclusion criteria
malignancy prostate or bladder, neurogenic bladder, diverticula/calculi, urethra strictures, dysfunction bladderneck, eGRF < 30, prostatits, cystitis, atherosclerosis AII, allergy to i.v. contrast
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8129 |
| CCMO | NL63097.028.18 |
| OMON | NL-OMON52683 |