The development of a novel patient reported outcome measure for the assessment of the signs, symptoms and impact of underactive bladder

Abstract

Underactive bladder (UAB) is a health issue which is receiving increasing attention in the urological literature. The most recent symptomatic definition approved by the International Continence Society steering committee in 2016 states: “Underactive bladder is characterised by a slow urinary stream, hesitancy and straining to void, with or without a feeling of incomplete bladder emptying and dribbling, often with storage symptoms”. UAB is considered a symptom syndrome suggestive of the urodynamic observation of detrusor underactivity (DU). The symptomatic burden of lower urinary tract symptoms (LUTS) associated with DU and known impact of LUTS on quality of life highlight the requirement to understand how the patient with UAB feels and functions for clinical outcome assessment purposes. Currently, no fully validated patient reported outcome (PRO) measures exist for the assessment of UAB. The thesis describes the development of the ICIQ-UAB, a new PRO measure for the assessment of the symptoms of UAB, and their associated bother and impact. Qualitative methodology was employed to understand how the clinical diagnosis of DU manifests as symptoms, by a thorough exploration of the lived experience of patients. Decisions on the inclusion of draft questionnaire items, including their content, language and response items, were made on the basis of the qualitative evidence and consultation with an expert clinical panel. Draft items were refined by cognitive interviews which confirmed the items to be understood and interpreted as intended by patients. Validity and test-retest reliability of the ICIQ-UAB was supported by a European pilot study, and the wider cultural applicability by additional patient interviews in the US and Japan. The developmental ICIQ-UAB is now ready for further large-scale validation in future clinical trials and is envisaged as an important tool for the monitoring of future UAB treatment strategies.

Date of Award	6 Nov 2018
Original language	English
Awarding Institution	The University of Bristol
Supervisor	Nikki Cotterill (Supervisor) & Marcus Drake (Supervisor)