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BMJ Open ; 13(10): e076621, 2023 10 06.
Artigo em Inglês | MEDLINE | ID: mdl-37802612

RESUMO

INTRODUCTION: Patients undergoing prostate radiotherapy with an enlarged prostate can have short-term and long-term urinary complications. Currently, transurethral resection of the prostate (TURP) is the mainstay surgical intervention for men with urinary symptoms due to an enlarged prostate prior to radiotherapy. UroLift (NeoTract, Pleasanton, CA, USA) is a recent minimally invasive alternative, widely used in benign disease but is untested in men with prostate cancer. METHODS AND ANALYSIS: A multicentre, two-arm study designed in collaboration with a Patient Reference Group to assess the feasibility of randomising men with prostate cancer and coexisting urinary symptoms due to prostate enlargement to TURP or UroLift ahead of radiotherapy. 45 patients will be enrolled and randomised (1:1) using a computer-generated programme to TURP or UroLift. Recruitment and retention will be assessed over a 12 month period. Information on clinical outcomes, adverse events and costs will be collected. Clinical outcomes and patient reported outcome measures will be measured at baseline, 6 weeks postintervention and 3 months following radiotherapy. A further 12 in-depth interviews will be conducted with a subset of patients to assess acceptability using the Theoretical Framework of Acceptability. Descriptive analysis on all outcomes will be performed using Stata (StataCorp V.2021). ETHICS AND DISSEMINATION: The trial has been approved by the Research Ethics Committee (REC) NHS Health Research Authority (HRA) and Health and Care Research Wales (HCRW). The results will be published in peer-reviewed journals, presented at national meetings and disseminated to patients via social media, charity and hospital websites. TRIAL REGISTRATION NUMBER: NCT05840549.


Assuntos
Hiperplasia Prostática , Neoplasias da Próstata , Ressecção Transuretral da Próstata , Humanos , Masculino , Estudos de Viabilidade , Londres , Próstata , Hiperplasia Prostática/complicações , Hiperplasia Prostática/radioterapia , Hiperplasia Prostática/cirurgia , Neoplasias da Próstata/radioterapia , Neoplasias da Próstata/cirurgia , Neoplasias da Próstata/complicações , Ressecção Transuretral da Próstata/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto
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