Efficacy and Tolerability of Tolterodine in Continent Male Patients With Overactive Bladder and Nocturia

Phillip Ginsberg¹, Zhonghong Guan², Joseph T. Wang^2
1Albert Einstein Medical Center, Philadelphia, PA;²Pfizer, Inc., New York, NY

Introduction - We evaluated the efficacy and safety of tolterodine extended release (TER) in continent male patients with overactive bladder (OAB) and nocturia.
Methods - Data from two 12-week placebo (PBO)-controlled trials of nighttime TER (4 mg QD) in patients with frequency (≥8 micturitions/24 h) and nocturia (≥2.5 episodes) were analyzed. Per micturition, patients recorded “how urgently they needed to pass urine” on a 5-point urgency rating scale: 1=none, 2=mild, 3=moderate, 4=severe, 5=incontinence. Micturitions were analyzed by urgency rating: total (1-5), non-OAB (1-2), OAB (3-5), and severe OAB (4-5).
Results - TER (n=371) significantly reduced urgency rating vs PBO (n=374). See Table for results. Adverse events (AEs) associated with TER vs PBO were low: dry mouth (11% vs 4%), constipation (2% vs 2%), and urinary retention (1% vs 1%).
Conclusion - Nighttime dosing with TER significantly reduced urgency-related micturitions without affecting non-OAB micturitions. Clinical efficacy was maintained over 24 hours. TER dosing was associated with few AEs and withdrawals, suggesting that a nighttime TER regimen may reduce the occurrence of AEs in patients with OAB and nocturia.
Table. Summary of Results

	PBO (n=374)			TER (n=371)
	Mean Micturitions/wk		Median % Δ	Mean Micturitions/wk		Median % Δ
	Baseline	Δ		Baseline	Δ
24 hour Total OAB Severe OAB	91.5 55.0 18.8	-8.0 -6.2 -3.7	-7.9 -9.5 -41.2	90.7 54.3 18.1	-11.0* -9.9* -7.7*	-10.8* -16.7* -68.2*
Nighttime Total OAB Severe OAB	24.4 15.9 5.8	-4.4 -3.1 -1.6	-17.6 -22.2 -50.0	24.1 16.0 5.9	-4.4 -4.2 -2.8*	-18.8 -27.3 -77.8*
	Mean Δ in Urgency Severity Rating Score
24 hour Nighttime Daytime	-0.03 -0.03 -0.02			-0.12* -0.17** -0.09*

*P<0.05; **P<0.001.

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