Table 3. Secondary Outcome Measures by Randomized Group.
| Outcome | d-Mannose (n = 303) | Placebo (n = 295) | P value |
|---|---|---|---|
| No. of days of moderately bad (or worse) symptoms of UTI | |||
| Adjusted median difference (95% CI)a | 0.00 (−0.36 to 0.36) | >.99 | |
| Median (IQR) [range] | 0.0 (0.0 to 2.0) [0.0 to 18.0] | 0.0 (0.0 to 2.0) [0.0 to 148.0] | NA |
| Mean (SD) | 1.7 (3.13) | 3.2 (12.15) | NA |
| Participants reporting a single day of moderately bad (or worse) symptoms, No. (%) | 104 (43.3) | 99 (43.2) | NA |
| Median (IQR) for those reporting a single day | 3.0 (1.0 to 5.0) | 3.0 (1.0 to 6.0) | NA |
| Missing | 63 | 66 | NA |
| Weekly symptom burden of UTI | |||
| Adjusted median difference (95% CI)a | 0.00 (−0.37 to 0.37) | >.99 | |
| Median (IQR) [range] | 0.0 (0.0 to 1.0) [0.0 to 4.0] | 0.0 (0.0 to 1.0) [0.0 to 5.0] | NA |
| Mean (SD) | 0.5 (0.80) | 0.6 (0.86) | NA |
| Missing | 85 | 87 | NA |
| Time to next consultation (days) with a clinically suspected UTI | |||
| Adjusted hazard ratio (95% CI)b | 0.86 (0.69 to 1.08) | .20 | |
| Time at risk, d | 36 263 | 33 337 | NA |
| Incidence rate (per 1000 d at risk) | 4.11 | 4.80 | NA |
| Missingc | 1 | 1 | NA |
| No. of clinically suspected UTIs | |||
| Adjusted incidence rate ratio (95% CI)d | 0.88 (0.72 to 1.08) | .21 | |
| Mean (SD) | 0.9 (1.19) | 1.0 (1.28) | NA |
| Median (IQR) [range] | 1.0 (0.0 to 1.0) [0.0 to 6.0] | 1.0 (0.0 to 2.0) [0.0 to 8.0] | NA |
| Missing | 9 | 6 | NA |
| No. of microbiologically proven UTIs | |||
| Adjusted incidence rate ratio (95% CI)d | 0.97 (0.63 to 1.48) | .88 | |
| Mean (SD) | 0.4 (0.87) | 0.4 (0.78) | NA |
| Median (IQR) [range] | 0.0 (0.0 to 0.0) [0.0 to 4.0] | 0.0 (0.0 to 1.0) [0.0 to 4.0] | NA |
| Missing | 54 | 51 | NA |
| No. of prescribed antibiotic courses for UTI | |||
| Adjusted incidence rate ratio (95% CI)d | 0.88 (0.69 to 1.12) | .29 | |
| Mean (SD) | 0.9 (1.32) | 1.1 (1.53) | NA |
| Median (IQR) [range] | 0.0 (0.0 to 1.0) [0.0 to 8.0] | 1.0 (0.0 to 2.0) [0.0 to 9.0] | NA |
| Missing | 9 | 6 | NA |
| No. of days prescribed antibiotics for UTI | |||
| Adjusted median difference (95% CI)a | −3.00 (−4.40 to −1.60) | <.001 | |
| Mean (SD) | 5.7 (12.49) | 6.3 (10.28) | NA |
| Median (IQR) [range] | 0.0 (0.0 to 7.0) [0.0 to 161.0] | 3.0 (0.0 to 7.0) [0.0 to 66.0] | NA |
| Missing | 9 | 6 | NA |
| Defined daily dose | |||
| Adjusted mean difference (95% CI)e | −0.10 (−0.23 to 0.02) | .11 | |
| Mean (SD) | 0.6 (0.72) | 0.7 (0.86) | NA |
| Median (IQR) [range] | 0.0 (0.0 to 1.0) [0.0 to 3.9] | 0.0 (0.0 to 1.0) [0.0 to 5.1] | NA |
| Missing | 9 | 6 | NA |
| Report of consumption of antibiotics | |||
| Adjusted relative risk (95% CI)d | 0.83 (0.66 to 1.04) | .10 | |
| Yes, No. (%) | 86 (36.3) | 100 (43.9) | NA |
| No, No. (%) | 151 (63.7) | 128 (56.1) | NA |
| Missing | 66 | 67 | NA |
| Count of consumption of antibiotics | |||
| Adjusted incidence rate ratio (95% CI)d | 0.73 (0.51 to 1.04) | .08 | |
| Mean (SD) | 2.1 (4.01) | 2.9 (5.31) | NA |
| Median (IQR) [range] | 0.0 (0.0 to 3.0) [0.0 to 27.0] | 0.0 (0.0 to 4.0) [0.0 to 29.0] | NA |
| Missing | 66 | 67 | NA |
Abbreviations: NA, not applicable; UTI, urinary tract infection.
a
Quantile regression modeled against randomized arm.
b
Mixed-effects Cox proportional hazards model modeled against randomized arm as a fixed effect and site as a random effect.
c
Two participants were excluded from the analysis due to having a next consultation with a clinically suspected UTI on the same day as randomization.
d
Log-Poisson generalized linear mixed-effects model with robust standard errors modeled against randomized arm as a fixed effect and site as a random effect.
e
Linear mixed-effects model modeled against randomized arm as a fixed effect and site as a random effect.