Urox containing concentrated extracts of Crataeva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root, in the treatment of symptoms of overactive bladder and urinary incontinence: a phase 2, randomised, double-blind placebo controlled trial

Table 2 Over active bladder and urinary incontinence symptoms frequency as recorded from micturition diaries

Variable	Placebo (mean ± SD)	UROX (mean ± SD)	OR (95% CI) Placebo vs treatment
Day frequency (n/day)
Week 0	11.57 ± 1.79	11.53 ± 1.54	0.95 (0.33 to 2.73)
Week 2	10.80 ± 2.44	8.94 ± 2.28	0.07 (0.04 to 0.13)^*
Week 4	10.60 ± 2.42	8.42 ± 2.46	0.04 (0.02 to 0.08)^*
Week 8	10.95 ± 2.47	7.69 ± 2.15	0.01 (0.01 to 0.02)^*
Nocturia (n/day)
Week 0	3.39 ± 1.52	4.02 ± 1.62	3.59 (1.39 to 9.21)^*
Week 2	2.94 ± 1.37	3.18 ± 1.72	0.40 (0.24 to 0.69)^*
Week 4	2.92 ± 1.30	2.70 ± 1.52	0.14 (0.08 to 0.24)^*
Week 8	3.14 ± 1.36	2.16 ± 1.49	0.03 (0.02 to 0.05)^*
Urgency (n/day)
Week 0	4.34 ± 2.89	3.80 ± 1.82	0.67 (0.23 to 1.94)
Week 2	3.65 ± 2.62	2.32 ± 2.09	0.16 (0.09 to 0.27)^*
Week 4	3.52 ± 2.68	1.88 ± 2.25	0.08 (0.04 to 0.13)^*
Week 8	3.93 ± 2.87	1.49 ± 2.31	0.02 (0.01 to 0.03)^*
Urgency Incontinence (n/day)
Week 0	2.71 ± 2.68	2.79 ± 1.50	1.70 (0.53 to 5.40)
Week 2	2.32 ± 1.54	1.85 ± 1.78	0.19 (0.09 to 0.40^)*
Week 4	1.82 ± 1.33	1.53 ± 2.41	0.19 (0.09 to 0.40)^*
Week 8	2.44 ± 2.38	1.24 ± 2.49	0.04 (0.02 to 0.09)^*
Stress Incontinence (n/day)
Week 0	2.19 ± 1.50	2.13 ± 1.14	0.97 (0.11 to 8.65)
Week 2	1.70 ± 1.49	1.27 ± 1.29	0.30 (0.07 to 1.29)
Week 4	1.85 ± 1.29	0.77 ± 0.94	0.06 (0.01 to 0.25)^*
Week 8	2.04 ± 1.51	0.73 ± 0.87	0.03 (0.01 to 0.15)^*
Total Incontinence (n/day)
Week 0	2.95 ± 2.65	3.31 ± 2.12	1.97 (0.65 to 5.98)
Week 2	2.56 ± 1.62	2.20 ± 2.09	0.23 (0.11 to 0.45)^*
Week 4	2.13 ± 1.42	1.74 ± 2.68	0.14 (0.07 to 0.27)^*
Week 8	2.70 ± 2.25	1.38 ± 2.73	0.03 (0.01 to 0.06)^*

OR (95% CI): odds ratio and 95% confidence interval for difference between the two treatments (includes participants who did not complete the study); Comparison made as change from baseline between the two conditions. Holm estimation test was used to adjust p-values for repeated measures
^*Significantly different between the two treatments at the specific time; Number of participants assessed for each symptom were according to if their baseline measures matched the inclusion criteria (see Table 2 for the exact number of participants)

ISSN: 2662-7671