Table 1.

Trial characteristics

	Clinical trial number
	Study 007 (N = 1012)	Study 027 (N = 854)	Study 037 (N = 850)	Study 041 (N = 848)	Study 047 (N = 596)
Inclusion criteria	Frequency* and UUI†	Frequency* urgency with or without UUI† and SUI	Frequency*, urgency and nocturia, with or without UUI†	Frequency*, urgency and nocturia, with or without UUI†	Frequency* and urgency with or without UUI†
Exclusion criteria	SUI Total urinary volume > 3 l/day Significant hepatic or renal disease UTI (symptomatic or recurrent) Interstitial cystitis, haematuria, or BOO Recent electrostimulation or bladder training therapy Indwelling catheter or intermittent self-catheterisation Pregnancy, lactation, or failure by women of childbearing age to use reliable contraception Use of CYP3A4 inhibitors Treatment within 2 weeks of study with OAB therapy or anticholinergic drugs	Total urinary volume > 3 l/day Significant hepatic or renal disease UTI (symptomatic or recurrent) Interstitial cystitis, haematuria, or BOO Pregnancy, lactation, or failure by women of childbearing age to use reliable contraception Use of CYP3A4 inhibitors Non-surgical treatment for incontinence within 4 weeks of study Incontinence treatment within 2 weeks of study	SUI PVR > 200 ml Qmax < 10 ml/s Total urinary volume > 3 l/day Significant hepatic or renal disease UTI (symptomatic or recurrent) Interstitial cystitis, haematuria Recent electrostimulation or bladder training therapy Indwelling catheter or intermittent self-catheterisation Pregnancy, lactation, or failure by women of childbearing age to use reliable contraception Use of CYP3A4 inhibitors Treatment within 2 weeks of study with OAB therapy or anticholinergic drugs	SUI PVR > 200 ml Qmax < 10 ml/s Total urinary volume > 3 l/day Significant hepatic or renal disease UTI (symptomatic or recurrent) Interstitial cystitis or haematuria Recent electrostimulation or bladder training therapy Indwelling catheter or intermittent self-catheterisation Pregnancy, lactation, or failure by women of childbearing age to use reliable contraception Use of CYP3A4 inhibitors Treatment within 2 weeks of study with OAB therapy or anticholinergic drugs	SUI Interstitial cystitis or BOO UTI during run-in period Recent electrostimulation or bladder training therapy Pregnancy, lactation, or failure by women of childbearing age to use reliable contraception Allergy to tolterodine Use of CYP3A4 inhibitors Treatment within 2 weeks of study with OAB therapy or anticholinergic drugs

BOO, bladder outlet obstruction; CYP, cytochrome P450; OAB, overactive bladder; PVR, postvoid residual volume; Q_max, maximal flow volume; SUI, stress urinary incontinence; UTI, urinary tract infection; UUI, urgency urinary incontinence.*Defined as ≥ 8 micturitions per day. †Defined as ≥ 5 episodes per week.