Cognitive functions and health-related quality of life in men with benign prostatic hyperplasia and symptoms of overactive bladder when treated with a combination of tamsulosin and solifenacin in a higher dosage

Figures & data

Table 1. Clinical characteristic of patients with BPH and OAB (n = 262).

Parameters	Group A (n = 93)	Group B (n= 83)	Group C (n= 86)
Average age, years	62.8 (9.7)	66.8 (8.2)	66.0 (13.6)
IPSS questionnaire (in scores)
Incomplete emptying	2.5 (0.5)	2.4 (0.6)	1.9 (0.8)
Intermittency	2.1 (0.8)	2.6 (1.2)	2.2 (1.5)
Weak stream	2.5 (0.9)	2.0 (0.9)	1.9 (0.8)
Straining	3.3 (1.1)	1.1 (0.9)	1.7 (1.3)
Nocturia	2.4 (0.7)	2.5 (1.5)	2.6 (1.8)
Total	12.8 (5.3)	10.6 (3.8)	13.0 (2.3)
OAB-AT questionnaire (in scores)
Daytime frequency	5.1 (2.5)	4.9 (2.1)	4.9 (3.4)
Nighttime frequency	2.1 (1.4)	2.4 (1.4)	2.5 (1.6)
Urgency	3.2 (2.2)	2.8 (1.8)	2.7 (1.0)
Urgency incontinence	2.3 (0.8)	2.1 (0.9)	2.3 (0.8)
Urodynamic parameters (uroflowmetry)
PVR, ml	52.1 (12.7)	61.0 (11.9)	66.0 (17.8)
Qaver, ml/s	12.1 (3.4)	15.4 (7.3)	14.5 (8.0)
Qmax, ml/s	16.5 (5.9)	18.0 (6.5)	19.6 (7.7)

Remark: Group A (tamsulosin 0.4 mg + solifenacin 5 mg per day).

Group B (tamsulosin 0.4 mg + solifenacin 10 mg).

Group C Control (tamsulosin 0.4 mg + placebo).

PVR: post void residual urine volume; Q_aver: average flow rate; Q_max: maximum flow rate.

Standard deviation (SD) is indicated in parentheses.

p values >.05 in all cases (differences between groups are unreliable).

Figure 1. Scheme of examination and treatment of patients with BPH and OAB (N = 273). Remark: I-PSS: International Prostate Symptom Score; OAB-AT: Over Active Bladder Awareness Tool; MMSE: Mini-Mental State Examination; COWAT: Controlled Oral Word Association Test; WAIS-R: Wechsler Adult Intelligence Scale; WMS-III-test: Wechsler III; LM test: logical memory; CVLT: California Verbal Learning Test; SF-36-Medical Outcomes Study: 36-Item Short-Form.

Table 2. Descriptive statistics of the cognitive status, HRQoL and functional status LUT in men with BPH and OAB after treatment (N = 262).

	Group A (n = 93)	Group B (n= 83)	Group C (n= 86)	Cohen d A/C	Cohen d B/C
Parameters of cognitive status
Mini-Mental State Examination (MMSE)	28.2 (1.1)	27.9 (0.8)	29.1 (1.4)	0.32	0.34
Controlled Oral Word Association Test	13.6 (7.1)	14.5 (4.9)	13.5 (3.9)	0.63	0.58
Digit span forward (WAIS-R)	5.0 (1.1)	5.1 (1.4)	5.5 (1.6)	0.49	0.44
Digit span backward (WAIS-R)	3.9 (0.8)	4.5 (1.0)	4.7 (0.6)	0.43	0.41
The Color Trails Test 1 (CTT1)	60.4 (24.9)	66.8 (19.8)	53.6 (17.5)	−0.54	−0.61
The Color Trails Test 2 (CTT2)	121.5 (42.0)	143.5 (34.1)	113.7 (24.1)	−1.67	−1.51
Spatial span forward (WMS-3)	6.5 (1.5)	5.9 (1.7)	6.8 (1.7)	0.47	0.43
Spatial span backward (WMS-3)	6.7 (1.1)	7.1 (1.1)	7.0 (0.9)	0.57	0.48
Logic memory 1 recall (WMS 3)	35.3 (4.9)	33.5 (6.7)	37.8 (11.8)	0.58	0.49
Logic memory 2 recall (WMS 3)	19.5 (5.9)	19.1 (8.7)	21.9 (7.3)	0.42	0.53
Logic memory 2 recognition (WMS 3)	19.5 (4.3)*	20.8 (3.2)*	29.9 (3.3)	1.95	1.65
Logic memory 2 % retention (WMS 3)	84.6 (10.2)	80.1 (7.8)	86.0 (12.4)	0.34	0.29
California Verbal Learning Test TL	50.1 (5.9)	50.4 (7.1)	52.4 (8.4)	0.36	0.55
California Verbal Learning Test SDFR	8.8 (5.6)	9.7 (1.9)	11.6 (4.9)	0.39	0.41
California Verbal Learning Test SDCR	11.5 (5.3)	10.3 (2.9)	12.7 (5.7)	0.62	0.57
California Verbal Learning Test LDFR	10.8 (3.9)	10.8 (2.6)	12.0 (3.7)	0.56	0.50
California Verbal Learning Test LDCR	11.8 (2.6)	10.6 (1.9)	11.9 (3.3)	0.51	0.46
Parameters of health-related quality of life
MOS-36 Vitality	55.6 (11.5)	67.8 (10.2)	51.7 (10.6)	0.78	0.80
MOS-36 Physical functioning	55.9 (8.8)	62.3 (11.8)*	39.8 (7.4)	0.87	0.94
MOS-36 Bodily pain	21.4 (9.6)	18.8 (8.4)	22.9 (12.9)	1.67	1.55
MOS-36 General health perceptions	67.3 (10.5)*	81.5 (8.9)**	44.8 (9.0)	0.92	1.23
MOS-36 Physical role functioning	60.5 (9.2)	67.8 (14.4)	50.3 (10.3)	0.69	0.59
MOS-36 Emotional role functioning	65.6 (5.6)**	89.5 (9.6)**	43.6 (8.4)	2.6	2.9
MOS-36 Social role functioning	72.5 (7.4)**	91.5 (11.3)**	41.9 (13.6)	2.7	3.11
MOS-36 Mental health	60.2 (8.5)	74.6 (7.8)*	45.6 (9.6)	0.9	1.40
Parameters of lower urinary tract status
Uroflowmetry PVR, ml	47.3 (13.7)	18.6 (12.6)**	60.9 (9.7)	0.71	1.37
Uroflowmetry Qaver, ml/s	21.5 (6.3)	20.6 (5.7)	17.7 (4.8)	0.63	0.66
OAB-AT Urgency incontinence	0.9 (0.7)	0.4 (0.4)*	2.0 (0.4)	0.67	1.13
OAB-AT Urgency	1.9 (0.7)	0.9 (0.5)*	2.5 (0.5)	0.63	1.04
IPSS Incomplete emptying	1.4 (0.9)	1.7 (0.5)	1.6 (1.1)	0.48	0.54
IPSS Weak stream	0.9 (1.3)	1.4 (1.1)	1.3 (0.6)	0.57	0.51

Remark: Group A (tamsulosin 0.4 mg + solifenacin 5 mg per day), Group B (tamsulosin 0.4 mg + solifenacin 10 mg), Group C Control (tamsulosin 0.4 mg + placebo).

Parameter values for the patient’s cognitive status scales and the functional state of the LUT are given in scores, HRQoL scales are in %, for uroflowmetry in units indicated in the table.

WAIS-R: Wechsler Adult Intelligence Scale-Revised; WMS-3: Wechsler Memory Scale 3; SDFR: short-delay free recall; SDCR: short-delay cued recall; LDFR: long-delay free recall; LDCD: long delay cued recall; MOS-36: Medical Outcomes Study 36-Item (MOS-36) Health Survey; OAB-AT: Over Active Bladder Awareness Tool; IPSS: International Prostate Symptom Score; PVR: post void residual (urine volume).

*< 0.05, **< 0.01 – value p for groups A/C and B/C.

Table 3. The relationship between assessment of the health-related quality of life, level of cognitive performance and the symptoms of lower urinary tract after treatment by solifenacin.

	Health-related quality of life markers
	PF			GHP			ERF			SRF			MH
	Groups			Groups			Groups			Groups			Groups
Cognitive markers	A	B	C	A	B	C	A	B	C	A	B	C	A	B	C
Cognitive markers
MMSE	0.24	0.14	0.17	0.11	0.21	0.27	0.09	0.24	0.29	0.26	0.21	0.17	0.13	0.28	0.23
COWAT	0.20	0.19	0.28	0.18	0.26	0.23	0.22	0.24	0.29	0.11	0.23	0.25	0.17	0.27	0.20
WAIS-R f	0.21	0.11	0.03	0.21	0.21	−0.24	0.09	0.13	0.18	0.07	0.19	0.14	0.13	0.26	0.23
WAIS-R b	0.25	0.08	0.16	0.14	0.27	0.20	0.23	0.11	0.22	0.24	0.18	0.17	0.02	0.12	0.31
CTT1	0.13	0.13	0.19	0.27	0.20	0.15	0.11	0.18	−0.08	0.21	0.26	0.05	0.13	0.29	0.15
CTT2	0.24	0.26	0.17	0.14	0.45*	0.31	0.18	0.41*	−0.21	0.20	0.28	0.19	0.14	0.16	0.25
LM 2R	0.21	0.11	0.16	0.15	0.22	0.27	0.13	0.21	0.28	0.23	0.24	0.17	0.18	0.24	0.14
CVLT TL	0.22	0.23	0.12	0.13	0.11	0.21	0.12	0.27	0.21	−0.17	−0.10	−0.20	0.14	0.22	0.12
Urodynamic markers
PVR	−0.34	−0.34*	−0.14	−0.31*	−0.80*	−0.27	−0.55*	−0.64*	−0.11	−0.55*	−0.90*	−0.17	−0.26	−0.30*	−0.05
OAB UI	−0.14	−0.29	−0.07	−0.29	−0.61*	−0.11	−0.45*	−0.54*	−0.13	−0.71*	−0.56	−0.19	−0.21	−0.31*	−0.03
OAB U	−0.25	−0.25	−0.09	−0.37*	−0.58*	−0.13	−0.49*	−0.71*	−0.19	−0.39*	−0.66	−0.28	−0.23	−0.28	−0.18
IPSS IE	−0.28	−0.11	−0.16	−0.25	−0.27	−0.20	−0.35	−0.25	−0.15	−0.28	−0.22	−0.13	−0.17	−0.28	−0.23
IPSS WS	−0.24	−0.12	−0.19	−0.21	−0.31*	−0.15	−0.39	−0.24	−0.09	−0.30	−0.29	−0.24	−0.22	−0.28	−0.20

Remark: Spearmen coefficient (*p < .05, 95% correlation limits).

MMSE: Mini-Mental State Examination; COWAT: Controlled Oral Word Association Test; WAIS-R f: digit span forward; WAIS-R b: digit span backward; CTT1: Color Trails Test 1; CTT2: Color Trails Test 2; LM 2 R: Logic memory 2 recognition (WMS 3); CVLT TL: California Verbal Learning Test TL; PF: physical functioning; GHP: general health perceptions; ERF: emotional role functioning; SRF: social role functioning; MH: mental health; PVR: post void residual (urine volume). OAB U AT U, UT: overactive bladder awareness tool, urgency, urgency incontinence; IPSS IE: incomplete emptying; IPSS WS: weak stream.

Figure 2. The relationship between assessment of level of cognitive performance before and after of treatment. Remark: WAIS-R F: digit span forward; WAIS-R B: digit span backward; COWAT: Controlled Oral Word Association Test; LM 2R: logic memory 2 recognition (WMS 3); MMSE: Mini-Mental State Examination; CVLT TL: California Verbal Learning Test TL; CTT1: Color Trails Test 1.

Table 4. The relationship between assessment of the level of cognitive performance and the symptoms of lower urinary tract.

	Urodynamic markers
	PVR			OAB UI			OAB U			IPSS IE			IPSS WS
	Groups			Groups			Groups			Groups			Groups
Cognitive markers	A	B	C	A	B	C	A	B	C	A	B	C	A	B	C
MMSE	−0.23	−0.18	−0.18	−0.14	−0.12	−0.41	−0.16	−0.12	−0.27	−0.29	−0.12	−0.24	−0.22	−0.40	−0.25
COWAT	−0.09	−0.16	−0.17	−0.26	−0.28	−0.21	−0.13	−0.15	−0.23	−0.22	−0.14	−0.14	−0.08	−0.06	−0.24
WAIS-R f	−0.24	−0.28	−0.26	−0.23	−0.16	−0.20	−0.20	−0.14	−0.05	−0.19	−0.21	−0.12	−0.26	−0.11	−0.12
WAIS-R b	−0.13	−0.14	−0.22	−0.10	−0.24	−0.27	−0.22	−0.23	−0.25	−0.13	−0.16	−0.22	−0.23	−0.27	−0.20
CTT1	−0.09	−0.06	−0.26	−0.27	−0.22	−0.14	−0.12	−0.28	−0.10	−0.14	−0.26	−0.21	−0.21	−0.30	−0.07
CTT2	−0.11	−0.34*	−0.24	−0.26	−0.19	−0.17	−0.26	−0.41*	−0.31	−0.21	−0.12	−0.14	−0.27	−0.21	−0.25
LM 2R	−0.21	−0.28	−0.24	−0.24	−0.20	−0.21	−0.23	−0.18	−0.17	−0.15	−0.16	−0.19	−0.21	−0.11	−0.13
CVLT TL	−0.13	−0.20	−0.17	−0.10	−0.15	−0.19	−0.15	−0.17	−0.16	−0.32	−0.13	−0.18	−0.07	−0.13	−0.18

Remark: Spearmen coefficient (*p<.05, 95% correlation limits).

MMSE: Mini-Mental State Examination; COWAT: Controlled Oral Word Association Test; WAIS-R f: digit span forward; WAIS-R b: Digit span backward; CTT1: Color Trails Test 1; CTT2: Color Trails Test 2; LM 2 R: Logic memory 2 recognition (WMS 3); CVLT TL: California Verbal Learning Test TL; PVR: post void residual (urine volume); OAB U AT U, UT: overactive bladder awareness tool, urgency, urgency incontinence; IPSS IE: incomplete emptying; IPSS WS: weak stream.