Patient based questionnaire for screening LUTS related to BPE/BPO
Research type
Research Study
Full title
Development of a patient based questionnaire for screening lower urinary tract symptoms related to benign prostatic enlargement/obstruction.
IRAS ID
146886
Contact name
Nikesh Thiruchelvam
Contact email
Research summary
The purpose of this study is the development of a questionnaire to allow General Practitioners (GP) to make a diagnosis of urinary symptoms related to Benign Prostatic Enlargement/Obstruction (BPE/BPO) rather than urinary symptoms that are due to other causes. It is hoped that this will help GPs to manage patients with urinary symptoms more effectively, and limit the need for hospital referrals.
The development of the questionnaire has been separated into different phases (IA, IB, II and III). Phases IA, IB and II have now been completed. This study will look at Phase III; by testing the reliability and validity of the questionnaire.
Testing of the questionnaire will be performed in the following languages: English, French, German, Italian and Spanish. In the UK testing will be performed using the English version of the questionnaire.
The questionnaire will be tested by males aged over the age of 50 with lower urinary tract symptoms. Half the men will have lower urinary tract symptoms due to BPE/BPO, and the other half will have lower urinary tract symptoms which are not due to BPE/BPO. In Europe approximately 400 males will participate and in the UK around 80 males will be involved.
The study will require participants to complete two questionnaires about their urinary tract symptoms. One of the questionnaires (IPSS Questionnaire) is already validated and widely used. The other questionnaire (BPE/BPO-S Version 0.2 Questionnaire) is the questionnaire being tested as part of this study. Following this phase of the study, version 1 of the BPE/BPO-S Questionnaire will be produced, which GP’s will be able to use to help diagnose urinary symptoms related to BPE/BPO.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
14/LO/0375
Date of REC Opinion
8 Apr 2014
REC opinion
Further Information Favourable Opinion