Hypothesis / aims of study
Infection with SARS-CoV-2 (COVID-19) can result in de novo or worsening genitourinary (GU) symptoms, such as frequency, urgency, nocturia, and pain/pressure, also referred to as COVID-19 associated cystitis (CAC).(1) The aim of this study was to follow progression of overactive bladder (OAB) symptoms in patients that previously reported new or worsening OAB symptoms after COVID-19 diagnosis.
Study design, materials and methods
19,128 individuals from a Beaumont COVID-19 serology study, were invited to participate in a follow-up study, with 2,137 subsequent respondents.(2) Participants were divided into a COVID-, Ser+ (positive serology test only) or PCR+ (positive PCR test) groups. Initially, patients were asked to score their OAB symptoms retrospectively prior to the pandemic (baseline) and at present time (day 0). Participants were subsequently asked to score their symptoms at 2-, 4-, 8- and 12-months follow-up. Participants that obtained COVID-19 diagnosis during follow-up phase were excluded from the study. Genitourinary symptoms were assessed using the International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB). The minimal important difference (MID) of ICIQ-OAB of 1 is considered a significant change. Data was collected between May 2021 and July 2022.
Statistical analysis was conducted using IBM SPSS 28.0 and R. Categorical data (e.g. demographics) was analyzed using Pearson’s Chi Square test. Continuous data, such as the average values for the ICIQ-OAB individual and total symptoms scores were calculated and the standard deviations provided. Statistical analysis was performed using 1-way ANOVA. A p-value <0.05 is considered significant. The effect of co-morbidities on change in ICIQ-OAB scores in patients based on COVID diagnosis was assessed using 1-way ANOVA followed by Tukey posthoc test.
Results
Of 2,137 participants, 564 (26.4%) previously tested positive for COVID, and 1,573 (73.6%) were COVID naïve (COVID-). Of these, 592 participants reported a ≥1 unit increase in OAB score at study onset (Day 0) compared to pre-pandemic; 243 (41%) were COVID-, 129 (21.8%) had positive serology test (Ser+), and 220 (37.2%) were COVID+ based on PCR test (PCR+) (Fig 1A). OAB score of these three cohorts were similar at pre-pandemic (2.71 vs 2.97 vs 2.53; p=0.193) but significantly higher at start of study (day 0) in PCR+ versus COVID- or Ser+ groups (5.83 vs 5.12 vs 5.33; p=0.019). In prospective follow-up, change in ICIQ-OAB scores from baseline were recorded at 2, 4, 8 and 12 months. At day 0, both Ser+ and PCR+ cohorts had significantly higher change in OAB score than COVID- group (2.8 and 3.11 vs 2.16; p=0.001). However, after 12 months follow-up, change in OAB score was similar between COVID- (1.86), Ser+ (2.15) and PCR+ (2.09) (Fig 1B). By 12 months, 74% of COVID-, 80.5% of Ser+ and 72.4% of PCR+ participants still reported significant increase in ICIQ-OAB scores from pre-pandemic levels.
Interpretation of results
We previously reported significantly higher increase in ICIQ-OAB scores in PCR+ and Ser+ participants compared to COVID– participants. We demonstrated that the incidence of CAC is 36.6% amongst symptomatic COVID positive patients, of which 22% was de novo.(3) This prospective analysis of patients with increased ICIQ-OAB score demonstrated amelioration of symptoms over 12 months specifically in PCR+ group.