Qualitative development of a new patient reported outcome measure for underactive bladder

Hypothesis / aims of study The patient experience of underactive bladder (UAB) was explored, for the purpose of developing a Patient Reported Outcome (PRO) measure to assess the symptoms and impact of the condition. UAB is currently proposed as the term to describe the symptom complex associated with urodynamically determined detrusor underactivity (DU), characterised by a bladder contraction of reduced strength and/or duration resulting in prolonged or incomplete emptying of the bladder. The PRO is being developed in accordance with the Food and Drug Agency PRO guidance for industry, for future use in research and clinical practice. Study design, materials and methods In-depth interviews were conducted with patients diagnosed with DU, followed by detailed qualitative analysis of the transcripts. Interviews continued until no new concepts were mentioned during further interviews (data saturation achieved). A draft PRO was developed in which each item corresponded to a symptom, sign or behaviour reported by patients and was worded with idiomatic language used by the patient population. Cognitive debriefing interviews were scheduled and iterative revisions of the PRO made, until no further changes were necessary.