Table 1.
Characteristics and results of studies on combination/add-on treatment with tamsulosin and solifenacin
| Author | Type of study | Number of participants | Trial design | Outcome measures | Efficacy of TAM + SOL* | Safety |
|---|---|---|---|---|---|---|
| Kaplan et al10 (VICTOR) | 12-week, double-blind, randomized, placebo-controlled | 397 | Run-in period: 4 weeks of TAM 0.4 mg 12 weeks of TAM 0.4 mg + SOL 5 mg (202 pts) or TAM 0.4 mg + pbo (195 pts) |
PVR, Qmax, daily micturitions, daily urgency episodes, PPBC, UPS, IPSS | vs TAM + pbo: Greater reduction in urgency | Adverse events rate was low, with dry mouth to be the most frequent (7% vs 3%) AUR in TAM + SOL (7%) |
| Masumori et al44 | 12-week, nonrandomized, no placebo | 48 | ≥4 weeks of TAM 0.2 mg before enrollment 12 weeks of TAM 0.2 mg + SOL 5 (31 pts) or 2.5 mg (17 pts) |
PVR, Qmax, IPSS, QoL index, OABSS | IPSS, storage IPSS, QoL, and OABSS improved after SOL add-on | No AUR No difference in PVR |
| Yamaguchi et al45 (ASSIST) | 12-week, double-blind, randomized, placebo-controlled | 638 | Run-in period: 2 weeks of TAM 0.2 mg or pbo 12 weeks of TAM 0.2 mg + pbo (215 pts), or TAM 0.2 mg + SOL 2.5 mg (210 pts), or TAM 0.2 mg + 5 mg (213 pts) |
PVR, Qmax, daily micturitions, nocturia episodes, daily urgency episodes, daily urgency incontinence episodes, IPSS, QoL, OABSS | vs TAM + pbo: Reduction in frequency (for both SOL 2.5 and 5 mg), urgency (for SOL 5 mg), nocturia, and urgency incontinence Improvements in total IPSS, storage IPSS (for both SOL 2.5 and 5 mg), voiding IPSS, QoL, and OABSS (for both concentrations) |
AUR 1.9% (SOL 5 mg); compared with baseline, PVR was significantly increased in both TAM + SOL groups |
| Kaplan et al47 | 12-week, double-blind, randomized, placebo-controlled | 192 | 12 weeks of pbo (62 pts), SOL 6 mg + TAM 0.4 mg (68 pts), or SOL 9 mg + TAM 0.4 mg (62 pts) | PVR, Qmax, PdetQmax, BCI, BVE, IPSS, PPBC, ICIQ-MaleLUTS, ICIQ-LUTSqol, voided volume/micturition, daily micturitions, daily urgency episodes, daily incontinence episodes | vs Pbo: Noninferior for PdetQmax and Qmax, improvement in frequency and voided volume vs baseline: PdetQmax lower for TAM + SOL 6 mg; increase in Qmax for both TAM + SOL groups |
AUR 0.5% in TAM + SOL; combination groups had significant PVR change at EoT vs pbo |
| Lee et al48 | 12-week, randomized, no placebo | 156 | Initial phase: 4 weeks of TAM 0.2 (80 pts) or 4 weeks of TAM 0.2 mg plus SOL 5 mg (76 pts) Second phase: 8 weeks of TAM 0.2 mg plus SOL 5 mg (156 pts) |
PVR, Qmax, IPSS, QoL, OABSS, PPBC, daily urgency episodes | 4th week vs TAM: improvement in storage IPSS and QoL 12th week: within each group, improvements in storage IPSS, OABSS, and urgency between 4th and 12th week | AUR: one patient after addition of SOL |
| Shin et al49 | 12-week, randomized, no placebo | 405 | 4 weeks wash-out before enrollment4 weeks of TAM 0.2 mg, then 4 weeks of TAM 0.2 mg + SOL 5 mg, then 4 weeks of TAM 0.2 + desmopressin 0.2 mg; or 4 weeks of TAM 0.2 mg, then 4 weeks of TAM 0.2 mg + desmopressin 0.2 mg, then 4 weeks of TAM 0.2 mg + SOL 5 mg | PVR, Qmax, IPSS, OABSS | vs baseline: Improvements in storage IPSS, OABSS, nocturia episodes, urgency episodes in patients with decreased nocturnal bladder capacity | |
| Yun et al50 | 4 weeks, randomized, no placebo | 344 | Randomization to storage or voiding group 4 weeks of TAM 0.2 mg or 4 weeks of TAM 0.2 mg + SOL 5 mg | IPSS (total, voiding, storage, QoL) | Storage group: improvements in total and storage IPSS and QoL vs baseline Voiding group: improvements vs TAM monotherapy | |
| van Kerrebroeck et al46 (SATURN) | 12-week, double-blind, randomized, placebo controlled | 937 | 2 week placebo run-in period 12-week treatment period with placebo (92 pts), SOL 3 mg (43 pts), SOL 6 mg (43 pts), SOL 9 mg (44 pts), TAM 0.4 mg (179 pts), TAM 0.4 mg + SOL 3 mg (180 pts), TAM 0.4 mg + SOL 6 mg (180 pts) and TAM 0.4 mg + SOL 9 mg (176 pts) |
IPSS, PPIUS, PPBC, TUFS, Qmax PVR, voided volume/micturition, daily micturition frequency, urgency episodes, nocturia, QoL | Post hoc analysis in moderate-to-severe storage symptoms: Storage IPSS, frequency, urgency, QoL, voided volume, TUFS, and PPBC improved vs TAM monotherapy | Minor PVR increase, clinically insignificant and irrelevant with the low AUR rates observed |
Note:
*
Only statistically significant results are provided.
Abbreviations: pts, patients; TAM, tamsulosin; SOL, solifenacin; pbo, placebo; PVR, postvoid residual; Qmax, maximum urinary flow rate; PPBC, patient perception of bladder capacity; UPS, Urgency Perception Scale; IPSS, International Prostate Symptom Score; AUR, acute urinary retention; QoL, quality of life; OABSS, Overactive Bladder Symptom Score; PdetQmax, detrusor pressure at maximum flow; BCI, Bladder Contractile Index; BVE, bladder voiding efficiency; ICIQ-MaleLUTS, Incontinence Questionnaire – Male Lower Urinary Tract Symptoms score; ICIQ-LUTSqol, ICIQ-LUTS quality-of-life score; EoT, end of treatment; PPIUS, Patient Perception of Intensity of Urgency Scale; TUFS, Total Urgency and Frequency Score.