Ray 2018.
Study characteristics | ||
Methods |
Study design: prospective cohort study (United Kingdom Register of Prostate Embolization) Setting/country: multicenter/UK Dates when study was conducted: July 2014 to January 2016 |
|
Participants |
Inclusion criteria: men with LUTS who had consented to undergo PAE, TURP, open prostatectomy, or holmium enucleation of the prostate at 1 of the United Kingdom Register of Prostate Embolization collaborating centers; were able to read, write, and understand English; and were capable of giving informed written consent Exclusion criteria: men who were unable to read, write, or understand English; unable/unwilling to provide informed written consent Total number of participants analyzed: 305 Group A (PAE)
Group B (TURP)
|
|
Interventions |
Group A: PAE Group B: monopolar and bipolar TURP Follow‐up: 12 months |
|
Outcomes |
Primary outcome
How measured: IPSS questionnaire Time points measured: at baseline, 1 month, 3 months, 6 months, and 12 months Time points reported: at baseline, 1 month, 3 months, 6 months, and 12 months Secondary outcomes
How measured: IPSS questionnaire/IIEF questionnaire Time points measured: at baseline, 1 month, 3 months, 6 months, and 12 months Time points reported: at baseline, 3 months, and 12 months
How measured: not reported/flow study Time points measured: at baseline, 3 months, and 12 months Time points reported: at baseline, 3 months, and 12 months Safety outcomes: adverse events How measured: Clavien Dindo Classification (by patients and clinicians) and retreatment (not defined in the methods section) Time points measured: at baseline, 1 month, 3 months, 6 months, and 12 months (by mail)/within 12 months and after 12 months Time points reported: likely cumulative incidence Subgroup: none |
|
Funding sources | Cook Medical, British Society of Interventional Radiologists, and British Association of Urological Surgeons. National Institute for Health and Care Excellence funded an independent academic unit (the Cardiff and Vale UHB/Cardiff University‐based unit, Cedar) to run the registry through a competitive tender. | |
Declarations of interest | The study included the coauthors who worked part‐time as a Consultant Clinical Advisor to the Interventional Procedures Programme at NICE and held a Consultant Contract with Boston Scientific, Terumo, Cook Medical, and Celonova. 1 coauthor was President of British Association of Urological Surgeons for 2014–2016. | |
Notes |
Protocol: NCT02434575 Language of publication: English |