Efficacy and safety of tamsulosin hydrochloride 0.2 mg and combination of tamsulosin hydrochloride 0.2 mg plus solifenacin succinate 5 mg after transurethral resection of the prostate: a prospective, randomized controlled trial

Figures & data

Figure 1 Consort study flow diagram.

Abbreviations: IPSS, International Prostate Symptom Score; TURP, transurethral resection of the prostate; TAM, tamsulosin hydrochloride 0.2 mg; SOL, solifenacin succinate 5 mg; wk, week.

Table 1 Demographic and other baseline characteristics

Characteristics	Group 1 (n=37)	Group 2 (n=37)	Group 3 (n=42)	P-value
Age, years	70.00±7.93	69.62±6.33	70.14±6.50	0.73
Body weight, kg	63.4±8.72	63.5±9.10	63.2±8.30	0.69
BMI, kg/m^2	23.8±2.83	23.6±2.74	23.7±3.18	0.84
PSA, ng/mL	4.56±4.04	5.05±4.99	4.17±3.60	0.74
TRUS
Total prostate volume, cm^3	58.25±24.13	51.92±18.34	51.51±19.88	0.96
Transition zone volume, cm^3	36.08±20.01	29.13±13.89	30.00±15.32	0.87
Uroflowmetry
Qmax, mL/s	10.77±4.95	9.00±4.68	10.22±5.70	0.63
Vvoid, mL	182.26±109.45	163.66±81.29	193.90±112.41	0.59
PVR, mL	99.56±120.50	82.26±73.93	92.32±97.24	0.68
IPSS questionnaires
Total score	17.64±8.40	18.52±6.17	18.51±7.70	0.97
Storage subscore	8.05±3.58	7.50±2.99	8.09±3.69	0.57
Voiding subscore	9.59±5.40	11.02±4.10	11.16±5.39	0.86
QoL subscore	3.64±1.25	3.86±1.22	4.04±1.41	0.74
OABSS total score	6.75±3.70	7.16±2.87	6.90±3.33	0.53
ICS short form
Voiding score	8.83±5.26	9.91±3.79	9.75±4.89	0.61
Storage score	2.78±2.88	3.44±2.71	3.25±3.13	0.63

Notes: Group 1, patients who underwent TURP; group 2, patients who underwent tamsulosin hydrochloride 0.2 mg after the removal of the Foley catheter after TURP; and group 3, patients who underwent tamsulosin hydrochloride 0.2 mg and solifenacin succinate 5 mg after the removal of the Foley catheter after TURP. Data represent mean ± SD.

Abbreviations: BMI, body mass index; PSA, prostate-specific antigen; TRUS, transrectal ultrasonography; Q_max, maximum flow rate; Vvoid, volume voided; PVR, postvoid residual; IPSS, International Prostate Symptom Score; QoL, quality of life; OABSS, Overactive Bladder Symptom Score; ICS, International Continence Society; TURP, transurethral resection of the prostate; SD, standard deviation.

Table 2 Mean change from baseline to the end of treatment

Parameters	Group 1 (n=37)	Group 2 (n=37)	95% CIa	P-value	Group 3 (n=42)	95% CIa	P-value
Change in efficacy assessments, adjusted mean ± SE
IPSS total score	−6.53±1.59	−7.21±1.29	−0.68 (−4.69, 3.33)	0.73	−6.35±1.31	−0.82 (−4.85, 3.21)	0.69
IPSS storage score	−2.41±0.73	−2.26±0.90	2.15 (0.44, 3.85)	0.02	−2.13±0.84	1.28 (−0.06, 3.22)	0.20
IPSS voiding score	−7.06±0.92	−7.00±1.40	0.06 (−2.57, 2.69)	0.96	−4.52±4.47	2.54 (−0.05, 5.13)	0.05
IPSS QoL score	−1.40±0.25	−0.74±0.41	0.67 (−0.10, 1.44)	0.08	−1.56±0.31	−0.16 (−0.93, 0.61)	0.67
OABSS total score	0.39±0.72	−0.55±0.70	−0.93 (−2.91, 1.04)	0.36	1.04±0.66	0.65 (−1.27, 2.58)	0.51
ICS voiding score	−4.30±0.65	−5.04±0.62	−0.75 (−2.51, 1.02)	0.42	−3.58±0.75	0.72 (−1.24, 2.67)	0.47
ICS storage score	0.43±0.50	0.23±0.33	−0.20 (−1.38, 0.97)	0.75	1.08±0.50	0.65 (−0.74, 2.04)	0.36
Vvoid per micturition, mL	18.25±8.05	18.17±7.11	−0.08 (−21.13, 20.97)	0.99	26.30±6.74	6.77 (−12.53, 28.63)	0.44
Change in safety variable, adjusted mean ± SE
PVR, mL	−1.5±5.99	18.67±6.65	20.17 (2.63, 37.71)	0.03	19.46±7.41	20.96 (2.28, 39.64)	0.03
Qmax, mL/s	6.97±1.41	7.01±0.74	0.04 (−3.08, 3.16)	0.97	7.16±1.70	0.19 (−4.13, 4.51)	0.93

Notes: Group 1, patients who underwent TURP; group 2, patients who underwent tamsulosin hydrochloride 0.2 mg after the removal of the Foley catheter after TURP; and group 3, patients who underwent tamsulosin hydrochloride 0.2 mg and solifenacin succinate 5 mg after the removal of the Foley catheter after TURP. Data represent mean ± SD.

a 95% CI for the treatment of medications versus TURP. Bold values indicate P<0.05.

Abbreviations: SE, standard error; IPSS, International Prostate Symptom Score; QoL, quality of life; OABSS, Overactive Bladder Symptom Score; ICS, International Continence Society; Vvoid, volume voided; PVR, postvoid residual; Q_max, maximum flow rate; CI, confidence interval; TURP, transurethral resection of the prostate; SD, standard deviation.

Figure 2 Mean change from baseline in Vvoid per micturition (A), and PVR (B) before surgery and at the 1-month and 2-month visits after surgery.

Abbreviations: Vvoid, volume voided; PVR, postvoid residual volume; TURP, transurethral resection of the prostate; TAM, tamsulosin hydrochloride 0.2 mg; SOL, solifenacin succinate 5 mg.