2243. Patient Perceptions of Treatment Success in Uncomplicated Urinary Tract Infection


 
 
 Regulatory guidance for developing uncomplicated urinary tract infection (uUTI) treatments requires endpoints assessing uUTI symptom resolution present at trial entry. The meaningfulness of this endpoint and definition of treatment success is rarely explored with patient-experience data (PED), and there is a paucity of PED in the literature.
 
 
 
 This cross-sectional interview study included English- and Spanish-speaking women aged ≥ 12 years with confirmed uUTI diagnosis within 14 days of screening. Interviews were recorded, transcribed and analyzed using qualitative methods. Participants were asked questions to elicit spontaneous and probed reports of uUTI symptoms and how these impacted health-related quality of life. Participants provided descriptions of symptom resolution, treatment success and evaluated a 4-point scale assessing dysuria, urinary frequency, urinary urgency and suprapubic pain. They were asked if the scale contents captured their uUTI experience, including assessing meaningful treatment effect.
 
 
 
 Overall, 30 participants were included, mean age 40 (range: 12–61) years. Urgency was the most common symptom reported (n=29, Table 1), and nearly all (n=29) participants reported their recent uUTI affected mood/emotions (Table 2). Participants reported the relevance of symptoms and the meaning of the points on the scale (Table 3). At interview, 24 participants scored each symptom as “none” and reported this was meaningful/important. Most participants (n=27) said they would not consider treatment successful if they still experienced ≥ 1 symptom by the end of the treatment period; however, almost half (n=14) agreed that with severe symptoms, the smallest meaningful improvement would be moving from severe to moderate. A limitation of this study is that participants were not asked about underlying symptoms between episodes of uUTI. Table 1.Patient-reported uUTI symptoms (N=30)*The symptom was not probed during the interview but was spontaneously reported by the participant(s). Abbreviation: uUTI, uncomplicated urinary tract infection.Table 2.Patient-reported impacts of uUTI (N=30)*The impact was not systematically probed during the interview but was spontaneously reported by the participant; †daily activities included cleaning, shopping, caring for children, exercising, or playing sports; ‡physical activities included walking, hiking, playing sports, exercising, and going to the gym; §adolescents (n=5) were not asked about intimate relationships.Abbreviation: uUTI, uncomplicated urinary tract infection.Table 3.Sample of quotations from patient interviewsAbbreviations: UTI, urinary tract infection; uUTI, uncomplicated urinary tract infection.
 
 
 
 Participants reported numerous impacts of uUTI. Definitions of symptom resolution and treatment success should be established with PED, with complete symptom resolution considered the most valued. The regulatory definition relevance of symptom resolution for uUTI and the content validity of a scale to assess symptom resolution was confirmed by participants.
 
 
 
 Claire L. Trennery, MSc, GlaxoSmithKline plc.: Employee and shareholder|GlaxoSmithKline plc.: GlaxoSmithKline plc.-sponsored study 217370 Susan Martin, MSPH, GlaxoSmithKline plc.: GlaxoSmithKline plc.-sponsored study 217370|RTI Health Solutions: Employee of RTI Health Solutions which received funding from GlaxoSmithKline plc. to conduct this study Katherine Kosa, MSc, GlaxoSmithKline plc.: GlaxoSmithKline plc.-sponsored study 217370|RTI Health Solutions: Employee of RTI Health Solutions which received funding from GlaxoSmithKline plc. to conduct this study Lydia Demetriou, MSc, GlaxoSmithKline plc.: Employee and shareholder|GlaxoSmithKline plc.: GlaxoSmithKline plc.-sponsored study 217370 Ashish V. Joshi, PhD, GlaxoSmithKline plc.: Employee and shareholder|GlaxoSmithKline plc.: GlaxoSmithKline plc.-sponsored study.
