BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.
