Yoshida et al. (3737 Yoshida M, Takeda M, Gotoh M, Nagai S, Kurose T. Vibegron, a Novel Potent and Selective β3-Adrenoreceptor Agonist, for the Treatment of Patients with Overactive Bladder: A Randomized, Double-blind, Placebo-controlled Phase 3 Study. Eur Urol. 2018;73:783-90.) 2018 No. JapicCTI- 152936 |
Phase IIb, RCT, double-blind, multicenter |
Japanese |
VIB 50mg, qd |
58.0 ± 11.8 |
334 (90.3) |
370 |
aged ≥ 20 years, patients experiencing OAB symptoms for ≥ 6 months |
VIB 100mg, qd |
58.7 ± 11.1 |
330 (89.7) |
368 |
PBO |
58.9 ± 11.8 |
333 (90.2) |
369 |
IMI 0.1mg, bid |
59.7 ± 12.4 |
105 (89.7) |
117 |
Yamaguchi et al. (3030 Yamaguchi O, Uchida E, Higo N, Minami H, Kobayashi S, Sato H, et al. Efficacy and safety of once-daily oxybutynin patch versus placebo and propiverine in Japanese patients with overactive bladder: A randomized double-blind trial. Int J Urol. 2014;21:586-93.) 2014a NCT00966004 |
Phase III, RCT, double-blind, multicenter |
Japanese |
MIR 50mg, qd |
58.3 ± 13.88 |
58 (15.7) |
379 |
aged ≥ 20 years, patients experiencing OAB symptoms for ≥ 24 weeks |
PBO |
58.2 ± 14.18 |
58 (15.8) |
379 |
TER 4 mg, qd |
58.3 ± 13.96 |
64 (17.4) |
375 |
Yamaguchi et al. (3838 Yamaguchi O, Marui E, Kakizaki H, Homma Y, Igawa Y, Takeda M, et al. Phase III, randomised, double-blind, placebo-controlled study of the β3-adrenoceptor agonist mirabegron, 50 mg once daily, in Japanese patients with overactive bladder. BJU Int. 2014;113:951-60.) 2014b NCT00527033 |
Phase II, RCT, double-blind, multicenter |
Japanese |
MIR 50mg, qd |
56.2 ± 13.59 |
31 (14.9) |
208 |
aged ≥ 20 years, patients experiencing OAB symptoms for ≥ 24 weeks |
PBO |
55.7 ± 12.89 |
42 (19.9) |
212 |
Staskin et al. (4343 Staskin D, Frankel J, Varano S, Shortino D, Jankowich R, Mudd PN Jr. International Phase III, Randomized, Double-Blind, Placebo and Active Controlled Study to Evaluate the Safety and Efficacy of Vibegron in Patients with Symptoms of Overactive Bladder: EMPOWUR. J Urol. 2020;204:316-24.) 2020 NCT03492281 |
Phase III, RCT, double-blind, multicenter |
Multinational |
VIB 75mg, qd |
63.0 ± 18.0 |
449 (85.4) |
545 |
aged ≥ 18 years, patients experiencing OAB symptoms for ≥ 3 months |
PBO |
61.0 ± 16.0 |
445 (85.6) |
540 |
TER 4 mg, qd |
61.0 ± 17.0 |
352 (84.4) |
430 |
Shin et al. (5555 Shin DG, Kim HW, Yoon SJ, Song SH, Kim YH, Lee YG, et al. Mirabegron as a treatment for overactive bladder symptoms in men (MIRACLE study): Efficacy and safety results from a multicenter, randomized, double-blind, placebo-controlled, parallel comparison phase IV study. Neurourol Urodyn. 2019;38:295-304.) 2019 |
Phase IV, RCT, double-blind, multicenter |
Korea |
MIR 50mg, qd |
66.40 ± 9.51 |
310 (100) |
310 |
aged ≥ 20 years, patients experiencing OAB symptoms for ≥ 12 weeks |
PBO |
65.23 ± 10.00 |
154 (100) |
154 |
Nitti et al. (4040 Nitti VW, Auerbach S, Martin N, Calhoun A, Lee M, Herschorn S. Results of a randomized phase III trial of mirabegron in patients with overactive bladder. J Urol. 2013;189:1388-95.) 2013 NCT00662909 |
Phase III, RCT, double-blind, multicenter |
United States and Canada |
MIR 50mg, qd |
59.2 ± 13.5 |
120 (27.1) |
442 |
aged ≥ 18 years, patients experiencing OAB symptoms for ≥ 3 months |
PBO |
60.1 ± 13.8 |
108 (23.8) |
453 |
Herschorn et al. (4141 Herschorn S, Barkin J, Castro-Diaz D, Frankel JM, Espuna-Pons M, Gousse AE, et al. A phase III, randomized, double-blind, parallel-group, placebo-controlled, multicentre study to assess the efficacy and safety of the β3 adrenoceptor agonist, mirabegron, in patients with symptoms of overactive bladder. Urology. 2013;82:313-20.) 2013 NCT00912964 |
Phase III, RCT, double-blind, multicenter |
Europe and North America |
MIR 50mg, qd |
60.3 ± 12.22 |
137 (31.1) |
440 |
aged ≥ 18 years, patients experiencing OAB symptoms for ≥ 3 months |
PBO |
58.2 ± 13.73 |
132 (30.5) |
433 |
Kuo et al. (7070 Kuo HC, Lee KS, Na Y, Sood R, Nakaji S, Kubota Y, et al. Results of a randomized, double-blind, parallel-group, placebo- and active-controlled, multicenter study of mirabegron, a β3-adrenoceptor agonist, in patients with overactive bladder in Asia. Neurourol Urodyn. 2015;34:685-92.) 2015 NCT01043666 |
Phase III, RCT, double-blind, multicenter |
Taiwan, Korea, China, and India |
MIR 50mg, qd |
54.3 ± 14.21 |
110 (32.5) |
366 |
aged ≥ 18 years, patients experiencing OAB symptoms for ≥ 3 months |
PBO |
55.3 ± 13.63 |
98 (30.3) |
366 |
TER 4 mg, qd |
53.9 ± 14.50 |
120 (36.0) |
371 |
Khullar et al. (4444 Khullar V, Amarenco G, Angulo JC, Cambronero J, Høye K, Milsom I, et al. Efficacy and tolerability of mirabegron, a β(3)-adrenoceptor agonist, in patients with overactive bladder: results from a randomised European-Australian phase 3 trial. Eur Urol. 2013;63:283-95.) 2013 NCT00689104 |
Phase III, RCT, double-blind, multicenter |
European–Australian |
MIR 50mg, qd |
59.1 ± 12.36 |
136 (27.6) |
493 |
aged ≥ 18 years, patients experiencing OAB symptoms for ≥ 3 months |
MIR 100mg, qd |
59.0 ± 12.71 |
141 (28.4) |
496 |
PBO |
59.2 ± 12.30 |
138 (27.9) |
494 |
TER 4 mg, qd |
59.1 ± 12.89 |
134(27.1) |
495 |
aged ≥ 18 years, patients experiencing symptoms of wet OAB for ≥ 3 months |
Herschorn et al. (4242 Herschorn S, Chapple CR, Abrams P, Arlandis S, Mitcheson D, Lee KS, et al. Efficacy and safety of combinations of mirabegron and solifenacin compared with monotherapy and placebo in patients with overactive bladder (SYNERGY study). BJU Int. 2017;120:562-75.) 2017 NCT01972841 |
Phase III, RCT, double-blind, multicenter |
Multinational (42 countries) |
MIR 50mg, qd |
56.7 ± 13.3 |
99 (23.5) |
422 |
PBO |
57.9±13.0 |
102 (23.8) |
429 |
Chapple et al. (7171 Chapple CR, Dvorak V, Radziszewski P, Van Kerrebroeck P, Wyndaele JJ, Bosman B, et al. A phase II dose-ranging study of mirabegron in patients with overactive bladder. Int Urogynecol J. 2013;24:1447-58.) 2013 NCT00337090 |
Phase II, RCT, double-blind, multicenter |
Multinational |
MIR 50mg, qd |
56.9 ± 12.5 |
18 (10.8) |
169 |
aged ≥ 18 years, patients experiencing symptoms of OAB for ≥ 3 months |
PBO |
57.1 ± 12.9 |
15 (9.0) |
169 |
TER 4 mg, qd |
56.6 ± 12.8 |
16 (18.8 |
85 |
Herschorn et al. (4242 Herschorn S, Chapple CR, Abrams P, Arlandis S, Mitcheson D, Lee KS, et al. Efficacy and safety of combinations of mirabegron and solifenacin compared with monotherapy and placebo in patients with overactive bladder (SYNERGY study). BJU Int. 2017;120:562-75.) 2017 NCT01314872 |
Phase IIb, RCT, double-blind, multicenter |
Multinational (18 countries) |
MIR 50mg, qd |
60.3 ± 8.7 |
129 (86.0) |
150 |
aged ≥ 18 years and ≤ 75years, patients experiencing symptoms of OAB for ≥ 3 months |
PBO |
57.8 ± 9.5 |
185 (90.2) |
205 |
TER 4 mg, qd |
58.5 ± 9.6 |
231 (89.9) |
257 |
Armstrong et al. (5858 Armstrong RB, Luber KM, Peters KM. Comparison of dry mouth in women treated with extended-release formulations of oxybutynin or tolterodine for overactive bladder. Int Urol Nephrol. 2005;37:247-52.) 2005 |
RCT, double-blind, multicenter |
Multicenter |
ER-OXY 10mg, qd |
60 (18–92) |
100% |
391 |
aged ≥ 18 years, patients experiencing symptoms |
TER 4 mg, qd |
60 (18–92) |
100% |
399 |
Cardozo et al. (5959 Cardozo L, Lisec M, Millard R, van Vierssen Trip O, Kuzmin I, Drogendijk TE, et al. Randomized, double-blind placebo controlled trial of the once daily antimuscarinic agent solifenacin succinate in patients with overactive bladder. J Urol. 2004;172(5 Pt 1):1919-24.) 2004 |
RCT, double-blind, multicenter |
Multinational |
SOL 5mg, qd |
55.4 (13.8) |
237 (82.9) |
286 |
aged ≥ 18 years, patients experiencing symptoms of OAB for ≥ 3 months |
SOL 10mg, qd |
55.9 (14.2) |
238 (82.1) |
290 |
PBO |
56.1 (13.3) |
227 (80.8) |
281 |
Chapple et al. (5757 Chapple C, DuBeau C, Ebinger U, Rekeda L, Viegas A. Darifenacin treatment of patients >or= 65 years with overactive bladder: results of a randomized, controlled, 12-week trial. Curr Med Res Opin. 2007;23:2347-58.) 2007a |
RCT, double-blind, multicenter |
Multinational |
DAR 7.5/15 mg, qd |
72 ± 5 (64–89) |
206 (77.4) |
266 |
aged ≥ 65 years with symptoms of OAB for at least 6 months |
PBO |
73 ± 5 (64–87) |
100 (75.2) |
133 |
Chapple et al. (6060 Chapple C, Schneider T, Haab F, Sun F, Whelan L, Scholfield D, et al. Superiority of fesoterodine 8 mg vs 4 mg in reducing urgency urinary incontinence episodes in patients with overactive bladder: results of the randomised, double-blind, placebo-controlled EIGHT trial. BJU Int. 2014;114:418-26.) 2014 NCT01302067 |
RCT, double-blind, multicenter |
Multinational |
FES 4 mg, qd |
59.8 (21–94) |
647 (82) |
790 |
aged ≥ 18 years with OAB symptoms for ≥ 6 months |
FES 8 mg, qd |
58.8 (18–89) |
627 (80) |
779 |
PBO |
59.6 (19–85) |
316 (82) |
386 |
Chapple et al. (1515 Chapple C, Van Kerrebroeck P, Tubaro A, Haag-Molkenteller C, Forst HT, Massow U, et al. Clinical efficacy, safety, and tolerability of once-daily fesoterodine in subjects with overactive bladder. Eur Urol. 2007;52:1204-12. Erratum in: Eur Urol. 2008 Jun;53(6):1319.) 2007b |
Phase III, RCT, double-blind, multicenter |
Multinational |
TER 4 mg, qd |
57.7±14.6 |
226 (78) |
290 |
aged ≥ 18 years with OAB symptoms for ≥ 6 months |
FES 8 mg, qd |
55.6 ± 14.1 |
223 (82) |
272 |
FES 4 mg, qd |
57.1 ± 13.2 |
232 (81) |
287 |
PBO |
56.0±13.7 |
229 (81) |
283 |
Chapple et al. (6161 Chapple CR, Martinez-Garcia R, Selvaggi L, Toozs-Hobson P, Warnack W, Drogendijk T, et al. A comparison of the efficacy and tolerability of solifenacin succinate and extended release tolterodine at treating overactive bladder syndrome: results of the STAR trial. Eur Urol. 2005;48:464-70.) 2005 |
RCT, double-blind, multicenter |
European |
SOL 5 mg/10mg, qd |
56.5 |
493 (85.3%) |
578 |
aged ≥ 18 years, patients experiencing OAB symptoms for ≥ 3 months |
TER 4 mg, qd |
56.4 |
529 (88.3%) |
599 |
Chapple et al. (1616 Chapple CR, Rechberger T, Al-Shukri S, Meffan P, Everaert K, Huang M, et al. Randomized, double-blind placebo- and tolterodine-controlled trial of the once-daily antimuscarinic agent solifenacin in patients with symptomatic overactive bladder. BJU Int. 2004;93:303-10.) 2004 |
Phase IIIa, RCT, double-blind, multicenter |
Multinational |
SOL 5 mg, qd |
58.1 (13.4) |
194 (72.9) |
266 |
aged ≥ 18 years, patients experiencing OAB symptoms for ≥ 3 months |
SOL 10 mg, qd |
57.2 (13.4) |
188 (71.2) |
264 |
TER 2mg bid |
56.9 (12.8) |
200 (80.0) |
250 |
PBO |
57.8 (13.7) |
193 (76.3) |
253 |
Choo et al. (1717 Choo MS, Lee JZ, Lee JB, Kim YH, Jung HC, Lee KS, et al. Efficacy and safety of solifenacin succinate in Korean patients with overactive bladder: a randomised, prospective, double-blind, multicentre study. Int J Clin Pract. 2008;62:1675-83.) 2008 NCT00189800 |
RCT, double-blind, multicenter |
Korea |
SOL 5 mg, qd |
53.07 10.52 |
90 (84.11) |
107 |
aged ≥ 18 years, patients experiencing OAB symptoms for ≥ 3 months |
SOL 10 mg, qd |
52.65 (12.71 |
83 (74.77) |
111 |
TOL 2 mg, bid |
53.05 (12.19 |
88 (79.28) |
111 |
Chu et al. (2020 Chu F, Smith N, Uchida T. Efficacy and safety of solifenacin succinate 10 mg once Daily: A multicenter, phase III, randomized, double-blind, placebo-controlled, parallel-group trial in patients with overactive bladder. Curr Ther Res Clin Exp. 2009:405-20.) 2009 |
Phase III, RCT, double-blind, multicenter |
United States |
SOL 10 mg, qd |
59 (14) |
272 (80.0) |
340 |
aged ≥ 18 years with a diagnosis of OAB made by an investigator based on symptoms |
PBO |
58 (13) |
277 (83.4) |
332 |
Chua et al. (1818 Chua ME, See MC 4th, Esmeňa EB, Balingit JC, Morales ML Jr. Efficacy and Safety of Gabapentin in Comparison to Solifenacin Succinate in Adult Overactive Bladder Treatment. Low Urin Tract Symptoms. 2018;10:135-42.) 2018 NCT01486706 |
RCT, double-blind, single center |
Philippines |
SOL 5 mg/10mg, qd |
57.2 (9.36) |
24 (77%) |
31 |
18–79 years old, patients who are ambulatory, with defined history of OAB symptoms for ≥ 3 months |
PBO |
53.9 (12.14) |
23 (72%) |
32 |
Chuang et al. (1919 Chuang YC, Lin CC, Chow PM, Lien CS, Tsui KH, Chou CL, et al. A double-blind, randomized, placebo-controlled, parallel study to evaluate the efficacy and safety of imidafenacin in patients with overactive bladder in Taiwan. Low Urin Tract Symptoms. 2021;13:108-17.) 2020 |
RCT, double-blind, multicenter |
Taiwan |
IMI 0.1 mg,bid |
59.84 |
23 (31.5%) |
73 |
patients ≥ 20 years of age, with OAB symptoms for ≥ 3 months |
PBO |
59.33 |
19 (48.7%) |
39 |
Diokno et al. (6262 Diokno AC, Appell RA, Sand PK, Dmochowski RR, Gburek BM, Klimberg IW, et al. Prospective, randomized, double-blind study of the efficacy and tolerability of the extended-release formulations of oxybutynin and tolterodine for overactive bladder: results of the OPERA trial. Mayo Clin Proc. 2003;78:687-95.) 2003 |
RCT, double-blind, multicenter |
US |
OXY 10 mg, qd |
(23, 92) |
100% |
391 |
Women with OAB symptoms, aged 18 years and older |
TER 4mg, qd |
(18, 85) |
100% |
399 |
Dmochowski et al. (2121 Dmochowski RR, Peters KM, Morrow JD, Guan Z, Gong J, Sun F, et al. Randomized, double-blind, placebo-controlled trial of flexible-dose fesoterodine in subjects with overactive bladder. Urology. 2010;75:62-8. Erratum in: Urology. 2010;75:1519. Erratum in: Urology. 2011;77:1513.) 2010 |
RCT, double-blind, multicenter |
US |
FES 4mg/8mg, qd |
59.7 (13.7) |
364 (83) |
438 |
Aged ≥ 18 years patients experiencing OAB symptoms for ≥ 3 months |
PBO |
60.1 (12.9) |
368 (83) |
445 |
Dmochowski et al. (2222 Dmochowski RR, Sand PK, Zinner NR, Staskin DR. Trospium 60 mg once daily (QD) for overactive bladder syndrome: results from a placebo-controlled interventional study. Urology. 2008;71:449-54.) 2008 |
Phase III, RCT, double-blind, multicenter |
US |
TRO 60mg, qd |
61.2 ± 0.7 |
230 (82.1) |
280 |
Subjects aged 18 years or older with OAB of 6 months or longer duration |
PBO |
58.4 ± 0.7 |
249 (87.7) |
284 |
Drutz et al. (1414 Drutz HP, Appell RA, Gleason D, Klimberg I, Radomski S. Clinical efficacy and safety of tolterodine compared to oxybutynin and placebo in patients with overactive bladder. Int Urogynecol J Pelvic Floor Dysfunct. 1999;10:283-9.) 1999 |
RCT, double-blind, multicenter |
United States and Canada |
TOL 2 mg, bid |
63.0 (31–88) |
88 (81) |
109 |
aged ≥ 18 years, patients experiencing OAB |
OXY 5 mg, tid |
66.3 (23–91) |
81 (72) |
112 |
PBO |
62.1 (26–87) |
45 (80) |
56 |
DuBeau et al. (2323 Dubeau CE, Kraus SR, Griebling TL, Newman DK, Wyman JF, Johnson TM 2nd, et al. Effect of fesoterodine in vulnerable elderly subjects with urgency incontinence: a double-blind, placebo controlled trial. J Urol. 2014;191:395-404.) 2014 NCT00928070 |
RCT, double-blind, multicenter |
US |
FES 4mg/8mg, qd |
74.8 (65- 91) |
100% |
103 |
65 years old or older with OAB symptoms for 3 or more months |
PBO |
75.3 (65-90) |
100% |
77 |
Ercan et al. (6363 Ercan Ö, Köstü B, Bakacak M, Aytaç-Tohma Y, Çoşkun B, Avcı F, et al. Comparison of solifenacin and fesoterodine in treatment of overactive bladder. Saudi Med J. 2015;36:1181-5.) 2015 |
RCT, single center |
Turkey |
SOL 5 mg, qd |
58.9 ± 11.5 |
UK |
60 |
patients diagnosed with OAB |
FES 4 mg, qd |
58.1 ± 10.258.1 |
UK |
59 |
Ginsberg et al. (6464 Ginsberg D, Schneider T, Kelleher C, Van Kerrebroeck P, Swift S, Creanga D, et al. Efficacy of fesoterodine compared with extended-release tolterodine in men and women with overactive bladder. BJU Int. 2013;112:373-85.) 2013 |
RCT, double-blind, multicenter |
Multinational |
FES 4mg/8mg, qd |
59.8 (14.3) 57.5 (13.0) |
1374 (84) |
1639 |
≥ 18 years old, had self-reported OAB symptoms for ≥ 3 months |
TER 4mg, qd |
60.8 (14.1) 57.8 (13.4) |
1382 (83) |
1657 |
PBO |
61.8 (13.9) 58.5 (13.2) |
679 (84) |
812 |
Gotoh et al. (2424 Gotoh M, Yokoyama O, Nishizawa O; Japanese Propiverine Study Group. Propiverine hydrochloride in Japanese patients with overactive bladder: a randomized, double-blind, placebo-controlled trial. Int J Urol. 2011;18:365-73.) 2011 |
Phase III, RCT, double-blind, multicenter |
Japan |
PRO 20 mg, qd |
56.6 (13.6) |
216 (76.1) |
284 |
≥ 20 years old with OAB symptoms for at least 12 weeks |
PBO |
58.7 (14.1) |
207 (76.7) |
270 |
Govier et al. (3030 Yamaguchi O, Uchida E, Higo N, Minami H, Kobayashi S, Sato H, et al. Efficacy and safety of once-daily oxybutynin patch versus placebo and propiverine in Japanese patients with overactive bladder: A randomized double-blind trial. Int J Urol. 2014;21:586-93.) 2010 |
Phase III, RCT, double-blind, multicenter |
US |
SOL 10 mg, qd |
60 ± 13 |
261 (82) |
318 |
Aged ≥ 18 years with OAB symptoms |
PBO |
59 ± 13 |
259 (82) |
316 |
Herschorn et al. (4141 Herschorn S, Barkin J, Castro-Diaz D, Frankel JM, Espuna-Pons M, Gousse AE, et al. A phase III, randomized, double-blind, parallel-group, placebo-controlled, multicentre study to assess the efficacy and safety of the β3 adrenoceptor agonist, mirabegron, in patients with symptoms of overactive bladder. Urology. 2013;82:313-20.) 2013 NCT01767519 |
Phase IIIb, RCT, double-blind, multicenter |
North America and Europe |
SOL 5 mg/10mg, qd |
61.4 ± 12.8 |
134 (88.7) |
151 |
Adults with symptoms of patients diagnosed OAB for ≥ 6 months |
PBO |
62.9 ± 11.8 |
51 (85.0) |
60 |
Homma et al. (5353 Homma Y, Paick JS, Lee JG, Kawabe K; Japanese and Korean Tolterodine Study Group. Clinical efficacy and tolerability of extended-release tolterodine and immediate-release oxybutynin in Japanese and Korean patients with an overactive bladder: a randomized, placebo-controlled trial. BJU Int. 2003;92:741-7. Erratum in: BJU Int. 2004;93:1135.) 2003 |
RCT, double-blind, multicenter |
Japanand Korea |
TER 4 mg, qd |
61.2 (11.8) |
162 (68) |
239 |
aged ≥ 20 years with symptoms of OAB for ≥ 6 months |
OXY 3 mg, qd |
57.9 (12.5) |
177 (73) |
244 |
PBO |
58.4 (14.0) |
84 (69) |
122 |
Homma et al. (2525 Homma Y, Yamaguchi O; Imidafenacin Study Group. A randomized, double-blind, placebo- and propiverine-controlled trial of the novel antimuscarinic agent imidafenacin in Japanese patients with overactive bladder. Int J Urol. 2009;16:499-506.) 2009 |
Phase III, RCT, double-blind, multicenter |
Japan |
IMI 0.1 mg, bid |
57.7 (12.7) |
278 (87.4%) |
324 |
≥ 20 years, who had OAB symptoms |
PRO 20 mg, qd |
59.8 (11.9) |
257 (84.3%) |
310 |
PBO |
58.0 (13.5) |
125 (87.4%) |
147 |
Homma et al. (2626 Homma Y, Yamaguchi T, Yamaguchi O. A randomized, double-blind, placebo-controlled phase II dose-finding study of the novel anti-muscarinic agent imidafenacin in Japanese patients with overactive bladder. Int J Urol. 2008;15:809-15.) 2008 |
Phase II, RCT, double-blind, multicenter |
Japan |
IMI 0.1 mg, bid |
64.5 (13.5) |
63 (67.7) |
93 |
≥ 20 years, who had OAB symptoms |
PBO |
61.9 (11.8) |
69 (72.6) |
95 |
Kaplan et al. (4545 Kaplan SA, Cardozo L, Herschorn S, Grenabo L, Carlsson M, Arumi D, et al. Efficacy and safety of fesoterodine 8 mg in subjects with overactive bladder after a suboptimal response to tolterodine ER. Int J Clin Pract. 2014;68:1065-73.) 2014 NCT01302054 |
RCT, double-blind, multicenter |
Europe, North America, Asia, and Africa |
FES 4mg/8mg, qd |
57.3 (13.4) |
253 (82) |
308 |
aged ≥ 18 years, self-reported OAB symptoms for ≥ 6 months |
PBO |
58.2 (13.2) |
244 (81) |
301 |
Karram et al. (3232 Karram MM, Toglia MR, Serels SR, Andoh M, Fakhoury A, Forero-Schwanhaeuser S. Treatment with solifenacin increases warning time and improves symptoms of overactive bladder: results from VENUS, a randomized, double-blind, placebo-controlled trial. Urology. 2009;73:14-8.) 2009 NCT00454896 |
Phase IIIb, RCT, double-blind, multicenter |
USA |
SOL 5 mg/10mg |
57 |
84.20% |
372 |
age 18 or older, OAB for at least 3 months |
PBO |
57 |
84.20% |
367 |
Lee et al. (2828 Lee KS, Park B, Kim JH, Kim HG, Seo JT, Lee JG, et al. A randomised, double-blind, parallel design, multi-institutional, non-inferiority phase IV trial of imidafenacin versus fesoterodine for overactive bladder. Int J Clin Pract. 2013;67:1317-26.) 2013 NCT01578304 |
Phase IV, RCT, double-blind, multicenter |
Korean |
IMI 0.1 m, bid |
57.94 ± 10.81 |
57.94 ± 10.81 |
104 |
aged ≥ 20 years, with OAB symptom for ≥ 3 months |
FES 4 mg, qd |
57.63 ± 12.63 |
57.63 ±12.63 |
102 |
Nitti et al. (4646 Nitti VW, Dmochowski R, Sand PK, Forst HT, Haag-Molkenteller C, Massow U, et al. Efficacy, safety and tolerability of fesoterodine for overactive bladder syndrome. J Urol. 2007;178:2488-94.) 2007 |
Phase III, RCT, double-blind, multicenter |
US |
FES 4 mg, qd |
59 (21–85) |
213 (76) |
282 |
18 years or older with OAB syndrome for 6 months or greater |
FES 8 mg, qd |
59 (23–91) |
218 (78) |
279 |
PBO |
59 (24–88) |
200 (74) |
271 |
Park et al. (4747 Park C, Park J, Choo MS, Kim JC, Lee JG, Lee JZ, et al. A randomised, prospective double-blind, propiverine-controlled trial of imidafenacin in patients with overactive bladder. Int J Clin Pract. 2014;68:188-96.) 2014 |
Phase III, RCT, double-blind, multicenter |
Korea |
IMI 0.1 m, bid |
58.31 ± 11.45 |
57 (85.07) |
82 |
OAB patients aged ≥ 19 years for ≥ 3 months. |
PRO 20mg, qd |
56.13 ± 11.29 |
55 (85.94) |
80 |
Rudy et al. (6666 Rudy D, Cline K, Harris R, Goldberg K, Dmochowski R. Multicenter phase III trial studying trospium chloride in patients with overactive bladder. Urology. 2006;67:275-80.) 2006 |
Phase III, RCT, double-blind, multicenter |
US |
TRO 40 mg, qd |
61.1 ± 0.69 |
267 (81.2) |
329 |
18 years or older with OAB symptoms for at least 6 months. |
PBO |
61.0 ± 0.70 |
269 (81.8) |
329 |
Sand et al. (6767 Sand PK, Miklos J, Ritter H, Appell R. A comparison of extended-release oxybutynin and tolterodine for treatment of overactive bladder in women. Int Urogynecol J Pelvic Floor Dysfunct. 2004;15:243-8.) 2004 |
RCT, double-blind, multicenter |
US |
ER-OXY 10 mg, qd |
58.4 |
100% |
152 |
Participants with overactive bladder |
TOL 2mg, bid |
58.8 |
100% |
163 |
Vardy et al. (3333 Vardy MD, Mitcheson HD, Samuels TA, Wegenke JD, Forero-Schwanhaeuser S, Marshall TS, et al. Effects of solifenacin on overactive bladder symptoms, symptom bother and other patient-reported outcomes: results from VIBRANT - a double-blind, placebo-controlled trial. Int J Clin Pract. 2009;63:1702-14.) 2009 NCT00573508 |
Phase IV, RCT, double-blind, multicenter |
US |
SOL 5 mg/10mg, qd |
59 ± 13 |
306 (81) |
377 |
(aged ≥ 18 years) were required to have OAB symptoms for ≥ 3 months |
PBO |
60 ± 12 |
314 (84) |
374 |
Wagg et al. (3434 Wagg A, Khullar V, Marschall-Kehrel D, Michel MC, Oelke M, Darekar A, et al. Flexible-dose fesoterodine in elderly adults with overactive bladder: results of the randomized, double-blind, placebo-controlled study of fesoterodine in an aging population trial. J Am Geriatr Soc. 2013;61:185-93.) 2013 NCT00798434 |
RCT, double-blind, multicenter |
Multinational |
FES 4mg/8mg, qd |
72.6 ± 5.8 |
213 (54) |
392 |
aged 65 and older with OAB symptoms for 3 months or longer |
PBO |
72.8 ± 5.7 |
205 (52) |
393 |
Weiss et al. (5050 Weiss JP, Jumadilova Z, Johnson TM 2nd, Fitzgerald MP, Carlsson M, Martire DL, et al. Efficacy and safety of flexible dose fesoterodine in men and women with overactive bladder symptoms including nocturnal urinary urgency. J Urol. 2013;189:1396-401. Erratum in: J Urol. 2013;190:816.) 2013 NCT00911937 |
RCT, double-blind, multicenter |
US |
FES 4mg/8mg, qd |
58.0 ± 14.7 |
313 (67.6) |
463 |
age 18 years or older with self-reported OAB symptoms for 3 or more months |
PBO |
57.5 ± 14.0 |
312 (65.8) |
474 |
Yamaguchi et al. (2929 Yamaguchi O, Marui E, Kakizaki H, Itoh N, Yokota T, Okada H, et al. Randomized, double-blind, placebo- and propiverine-controlled trial of the once-daily antimuscarinic agent solifenacin in Japanese patients with overactive bladder. BJU Int. 2007;100:579-87.) 2007 |
Phase III, RCT, double-blind, multicenter |
Japan |
SOL 5 mg, qd |
60.4 (13.3) |
318 (83.0) |
398 |
aged ≥ 20 years and with symptoms of OAB reported for ≥ 6 months |
SOL 10 mg, qd |
59.9 (13.0) |
318 (85.7) |
381 |
PRO 20 mg, qd |
59.6 (13.6) |
321 (83.6) |
400 |
PBO |
60.8 (12.5 |
333 (84.3) |
405 |
Yamaguchi et al. (2727 Yamaguchi O, Nishizawa O, Takeda M, Yoshida M, Choo MS, Gu Lee J, et al. Efficacy, Safety and Tolerability of Fesoterodine in Asian Patients with Overactive Bladder. Low Urin Tract Symptoms. 2011;3:43-50.) 2011 NCT00561951 |
Phase II, RCT, double-blind, multicenter |
Japan, Taiwan, Korea, and Hong Kong |
FES 4 mg, qd |
57.2 (14.2) |
251 (78.4) |
320 |
≥ 20 years of age; a medical history of OAB symptoms for ≥ 6 months |
FES 8 mg, qd |
58.8 (13.4) |
255 (81.5) |
313 |
PBO |
56.7 (13.5) |
251 (78.9) |
318 |
Yamaguchi et al. (3838 Yamaguchi O, Marui E, Kakizaki H, Homma Y, Igawa Y, Takeda M, et al. Phase III, randomised, double-blind, placebo-controlled study of the β3-adrenoceptor agonist mirabegron, 50 mg once daily, in Japanese patients with overactive bladder. BJU Int. 2014;113:951-60.) 2014b JapicCTI-101309 |
RCT, double-blind, multicenter |
Japan |
PRO 20 mg, qd |
55.6 (12.5) |
478 (85.5) |
576 |
Age ≥ 20 years, OAB symptoms for ≥ 24 weeks |
PBO |
56.2 (13.2) |
344 (92.2) |
381 |
Zinner et al. (6868 Zinner N, Gittelman M, Harris R, Susset J, Kanelos A, et al. Trospium chloride improves overactive bladder symptoms: a multicenter phase III trial. J Urol. 2004;171(6 Pt 1):2311-5, quiz 2435.) 2004 |
Phase III, RCT, double-blind, multicenter |
US |
TRO 20 mg, qd |
63 ± 0.8 |
203 (77.5) |
256 |
aged ≥ 18 years with a history of OAB for ≥ 6 months |
PBO |
61.5 ±0.8 |
186 (71.3) |
256 |
Zinner et al. (6969 Zinner N, Susset J, Gittelman M, Arguinzoniz M, Rekeda L, Haab F. Efficacy, tolerability and safety of darifenacin, an M(3) selective receptor antagonist: an investigation of warning time in patients with OAB. Int J Clin Pract. 2006;60:119-26. Erratum in: Int J Clin Pract. 2006;60:890.) 2006 |
RCT, double-blind, single center |
US |
DAR 15 mg, qd |
59.1 (20–93) |
185 (86.4) |
214 |
aged ≥ 18 years with a history of OAB for ≥ 6 months |
PBO |
59.1 (18–89) |
198 (88.0 |
225 |
Dmochowski et al. (5454 Dmochowski RR, Sand PK, Zinner NR, Gittelman MC, Davila GW, Sanders SW; Transdermal Oxybutynin Study Group. Comparative efficacy and safety of transdermal oxybutynin and oral tolterodine versus placebo in previously treated patients with urge and mixed urinary incontinence. Urology. 2003;62:237-42.) 2003 |
RCT, double-blind, multicenter |
UK |
ER-TOL 4mg, qd |
62.9[13.5] |
117 (95.1) |
123 |
at least 18 years of age taking current pharmacologic treatment for OAB |
PBO |
64.5 [12.3] |
109 (93.2) |
117 |
Haab et al. (7272 Haab F, Stewart L, Dwyer P. Darifenacin, an M3 selective receptor antagonist, is an effective and well-tolerated once-daily treatment for overactive bladder. Eur Urol. 2004;45:420-9; discussion 429.) 2004 |
RCT, double-blind, multicenter |
Multinational |
DAR 7.5 mg, qd |
57.7 (22–88) |
194 (84.7) |
229 |
(aged 19–88 years, 85% female) who had suffered from symptoms of OAB for at least 6 months |
DAR 15 mg, qd |
56.6 (24–81) |
100 (87.0) |
115 |
PBO |
56.5 (19–81) |
138 (84.1) |
164 |
Herschorn et al. (4949 Herschorn S, Heesakkers J, Castro-Diaz D, Wang JT, Brodsky M, Guan Z; Disease Management Study Team. Effects of tolterodine extended release on patient perception of bladder condition and overactive bladder symptoms*. Curr Med Res Opin. 2008;24:3513-21.) 2008 NCT00143377 |
RCT, double-blind, multicenter |
Multinational |
ER-TOL 4 mg, qd |
58 (13) |
290 (72) |
408 |
aged ≥ 18 years with a history of OAB for ≥ 3 months |
PBO |
57 (14) |
143 (71) |
204 |
Hill et al. (7373 Hill S, Khullar V, Wyndaele JJ, Lheritier K; Darifenacin Study Group. Dose response with darifenacin, a novel once-daily M3 selective receptor antagonist for the treatment of overactive bladder: results of a fixed dose study. Int Urogynecol J Pelvic Floor Dysfunct. 2006;17:239-47.) 2006 |
RCT, double-blind, multicenter |
Multinational |
DAR 7.5 mg, qd |
56.1 (23–88) |
94 (87.04) |
108 |
aged ≥ 18 years with a history of OAB for ≥ 6 months |
DAR 15 mg, qd |
55.1 (24–82) |
92 (85.98) |
107 |
PBO |
53.7 (21–85) |
90 (82.57) |
109 |
Kaplan et al. (4848 Kaplan SA, Schneider T, Foote JE, Guan Z, Carlsson M, et al. Superior efficacy of fesoterodine over tolterodine extended release with rapid onset: a prospective, head-to-head, placebo-controlled trial. BJU Int. 2011;107:1432-40.) 2011 NCT00611026 |
RCT, double-blind, multicenter |
Multinational |
ER-TOL 4 mg, qd |
58.1 (13.8) |
818 (84) |
960 |
(≥ 18 years) self-reported OAB symptoms for ≥ 3 months |
FES 4mg/8mg, qd |
57.9 (13.5) |
816 (85) |
973 |
PBO |
59.5 (13.2) |
410 (86) |
478 |
Van Kerrebroeck et al. (3535 Van Kerrebroeck P, Kreder K, Jonas U, Zinner N, Wein A; Tolterodine Study Group. Tolterodine once-daily: superior efficacy and tolerability in the treatment of the overactive bladder. Urology. 2001;57:414-21.) 2001 |
RCT, double-blind, multicenter |
Australasia, Europe and North America |
ER-TOL 4 mg, qd |
60 (20–89) |
417(82.25) |
507 |
aged ≥ 18 years with a history of OAB for ≥ 6 months |
TOL2 mg, bid |
60 (22–92) |
408(79.38) |
514 |
PBO |
61 (22–93) |
410(80.71) |
508 |
Rogers et al. (5151 Rogers R, Bachmann G, Jumadilova Z, Sun F, Morrow JD, Guan Z, et al. Efficacy of tolterodine on overactive bladder symptoms and sexual and emotional quality of life in sexually active women. Int Urogynecol J Pelvic Floor Dysfunct. 2008;19:1551-7.) 2008 NCT00143481 |
RCT, double-blind, multicenter |
US |
ER-TOL 4 mg, qd |
49 (12) |
100% |
202 |
aged ≥ 18 years with OAB symptoms for ≥ 3 months |
PBO |
47 (12) |
100% |
211 |
Zinner et al. (3636 Zinner NR, Mattiasson A, Stanton SL. Efficacy, safety, and tolerability of extended-release once-daily tolterodine treatment for overactive bladder in older versus younger patients. J Am Geriatr Soc. 2002;50:799-807.) 2002 |
RCT, double-blind, multicenter |
Europe, United States, Canada, Australia, and New Zealand |
ER-TOL 4 mg, qd |
51 ± 10.5 |
417 (82.25) |
507 |
aged ≥ 18 years with OAB symptoms for ≥ 6 months |
PBO |
74 ± 6 |
410 (80.71 |
508 |
Batista et al. (5656 Batista JE, Kölbl H, Herschorn S, Rechberger T, Cambronero J, Halaska M, et al. The efficacy and safety of mirabegron compared with solifenacin in overactive bladder patients dissatisfied with previous antimuscarinic treatment due to lack of efficacy: results of a noninferiority, randomized, phase IIIb trial. Ther Adv Urol. 2015;7:167-79.) 2015 |
Phase III, RCT, double-blind, multicenter |
Multinational |
MIR 50 mg, qd |
56.7 (14.3) |
712 (76.1) |
936 |
aged ≥ 18 years old, with symptoms of OAB for ≥ 3 months |
SOL 5 mg, qd |
57.4 (13.6) |
709 (75.9) |
934 |