Background: Tolterodine extended release (ER) is indicated for overactive bladder (OAB), which is often accompanied by nocturia. We evaluated the efficacy and tolerability of tolterodine ER in patients with OAB and nocturia who were continent at baseline as reported in diaries.
Methods: We conducted a secondary analysis of data from a 12-week, randomized, placebo-controlled trial of nighttime dosing (≤4 h before bed) of tolterodine ER (4 mg QD) in continent (0 urgency incontinence episodes/wk at baseline) patients with urinary frequency (≥8 micturitions/24 h) and nocturia (mean ≥2.5 episodes/night). Change from baseline to week 12 in micturition endpoints was assessed using a 7-day diary. Patients rated the urgency associated with each micturition using a 5-point urgency rating scale (1=none, 2=mild, 3=moderate, 4=severe, 5=urgency incontinence). Each micturition was categorized by urgency rating: total (urgency rating 1-5), non-OAB (1-2), OAB (3-5), and severe OAB (4-5).
Results: 513 continent OAB patients (58% men; mean age, 57 y) were enrolled. After 12 weeks of treatment, tolterodine ER significantly decreased 24-hour total, OAB, and severe OAB micturitions as well as nighttime OAB and severe OAB micturitions compared with placebo (Table). Adverse events associated with nighttime dosing of tolterodine ER were low (dry mouth, 9% vs 2% for placebo; constipation, 3% vs 2%; nasopharyngitis, 3% vs 1%; and headache, 2% vs 2%). Withdrawals due to adverse events associated with tolterodine ER (2% vs 3% for placebo) also were low.
Conclusions: In patients with OAB who were continent based on baseline diary entries, significantly greater reductions in 24-hour total, OAB, and severe OAB micturitions and in nighttime OAB and severe OAB micturitions were achieved with tolterodine ER compared with placebo. Nighttime dosing of tolterodine ER maintained 24-hour efficacy and was associated with few adverse events and withdrawals. Further study is needed to understand the clinical profile of tolterodine ER in OAB patients without urgency incontinence.
Table. Summary of Results

	Placebo (n=243)			Tolterodine ER (n=270)
	Micturition Frequency/wk
	Baseline Mean	Mean Change	Median % Change	Baseline Mean	Mean Change	Median % Change
24 hour† Total (1-5) OAB (3-5) Severe OAB (4-5) Nighttime† Total (1-5) OAB (3-5) Severe OAB (4-5)	91.8 48.6 10.3 24.5 14.8 3.5	-8.0 -3.0 0.4 -4.4 -2.4 -0.3	-6.9 -10.8 -17.0 -15.0 -22.9 -51.5	92.4 48.6 11.1 24.8 14.4 3.7	-13.5** -8.4* -3.4* -5.2 -3.6 -1.2*	-13.6* -17.7* -53.3 -21.2 -28.6* -65.0

ER=extended release; OAB=overactive bladder.
*P≤0.05; **P<0.01 versus placebo.
^†Micturitions were categorized by urgency rating, ranging from 1 (none) to 5 (urgency incontinence).

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