A parallel, randomized, double-blind, placebo-controlled study to investigate the effect of SagaPro on nocturia in men

Figures & data

Table I. Initial clinical characteristics of patients finishing treatment.

	n	Average age and range (years)	Average no. of nocturnal voids	Patients with sleep disorders
Placebo	35	67.44 (47–85)	2.74	5
SagaPro	31	66.31 (49–86)	2.81	3

Table II. Number of adverse events related to the study drug.

	Placebo		SagaPro
Related to study drug	n	%	n	%
Probably	0	0.00	0	0.00
Possibly	1	4.17	3	14.29
Not related	23	95.83	18	85.71

Table III. Average duration of sleep for both treatment groups with standard error of the mean and range.

	SagaPro (n = 31)		Placebo (n = 35)
	Before	After	Before	After
Average sleep (min)	508.1 ± 12.8	493.4 ± 13.7	532.1 ± 12.2	500.7 ± 10.8
Range (three-night average)	390–692	362–705	373–643	390–645

Table IV. Changes in main nocturia-related parameters for the treatment groups.

	SagaPro (n = 31)			Placebo (n = 35)
	Before	After	% Change	Before	After	% Change	p
ANV	2.81 ± 1.06	1.98 ± 1.18	–29.5	2.74 ± 0.78	1.93 ± 1.040	–29.6	0.946
Voids per hour sleeping time	0.331 ± 0.104	0.235 ± 0.117	–29.0	0.311 ± 0.080	0.231 ± 0.122	–25.7	0.478
24 h voided volume (ml)	1817 ± 432	1645 ± 442	–9.5	1578 ± 349	1466 ± 440	–7.1	0.490
Nocturnal urine volume (ml)	784 ± 318	644 ± 194	–17.9	704 ± 226	586 ± 246	–16.8	0.694
NPi	0.426 ± 0.113	0.404 ± 0.124	–5.2	0.454 ± 0.121	0.404 ± 0.121	–11.0	0.292
NBC index	1.50 ± 0.70	1.02 ± 0.58	–32.0	1.58 ± 0.74	1.14 ± 0.71	–27.8	0.716

Data are shown as mean ± SD.

ANV = actual number of nocturnal voids; NPi = nocturnal polyuria index; NBC index = nocturnal bladder capacity index.

Table V. Changes in nocturia-related parameters for the treatment groups for the 36 patients with nocturnal bladder capacity index (NBC index) above 1.3 initially.

	SagaPro (n = 12)			Placebo (n = 24)
	Before	After	% Change	Before	After	% Change	p
ANV	3.56 ± 1.34	2.26 ± 1.70	–36.5	2.90 ± 0.86	2.00 ± 0.95	–31.0	0.150
Voids per hour sleeping time	0.404 ± 0.126	0.251 ± 0.161	–37.9	0.332 ± 0.081	0.243 ± 0.111	–26.8	0.034
24 h voided volume (ml)	1991 ± 419	1804 ± 441	–9.4	1614 ± 345	1505 ± 460	–6.8	0.540
Nocturnal urine volume (ml)	853 ± 378	694 ± 244	–18.6	677 ± 234	560 ± 215	–17.3	0.578
NBC index	2.17 ± 0.70	1.25 ± 0.81	–42.4	1.85 ± 0.72	1.23 ± 0.72	–33.5	0.044
Average nocturnal voided volume	204 ± 82	269 ± 114	31.9	190 ± 67	222 ± 104	16.8	0.150
Smallest nocturnal volume voided	121 ± 51	231 ± 126	90.9	135 ± 53	190 ± 112	40.7	0.098

Data are shown as mean ± SD.

ANV = actual number of nocturnal voids.

Figure 1. (A) Actual number of nocturnal voids (ANV); (B) nocturnal voids (NV) per hour sleeping time; and (C) and nocturnal bladder capacity index (NBC index) before and after treatment, for the 36 participants with baseline NBC index above 1.3. The SagaPro group is shown with triangles and the placebo group with circles. Points lying on the equality line indicate no change after treatment, whereas points lying under the line indicate a reduction and points lying above indicate an increase during the treatment period.

Table VI. Changes in nocturia-related parameters for the treatment groups for the 29 patients with nocturnal bladder capacity index (NBC index) above 1.3 initially, after exclusion of patients on medication for sleep disorders.

	SagaPro (n = 10)			Placebo (n = 19)
	Before	After	% Change	Before	After	% Change	p
ANV	3.43 ± 1.27	1.97 ± 1.51	–42.6	2.67 ± 0.71	1.84 ± 0.80	–31.1	0.020
Voids per hour sleeping time	0.404 ± 0.133	0.229 ± 0.161	–43.3	0.315 ± 0.076	0.233 ± 0.106	–26.0	0.004
24 h voided volume (ml)	2029 ± 429	1837 ± 472	–9.5	1646 ± 308	1547 ± 451	–6.0	0.546
Nocturnal urine volume (ml)	851 ± 409	647 ± 225	–24.0	650 ± 216	540 ± 193	–16.9	0.276
NBC index	2.22 ± 0.77	1.21 ± 0.87	–45.5	1.81 ± 0.72	1.18 ± 0.70	–34.8	0.026
Average nocturnal voided volume	210 ± 89	278 ± 122	32.4	194 ± 66	220 ± 91	13.4	0.102
Smallest nocturnal volume voided	124 ± 55	243 ± 131	96.0	136 ± 54	186 ± 99	36.8	0.056

Data are shown as mean ± SD.

ANV = actual number of nocturnal voids.