Nighttime dosing with tolterodine reduces overactive bladder-related nocturnal micturitions in patients with overactive bladder and nocturia.
OBJECTIVE
To evaluate the efficacy and tolerability of nighttime tolterodine dosing on urgency-related micturitions in patients with overactive bladder (OAB) and nocturia.


METHODS
This was a 12-week randomized controlled study of 850 patients given 4 mg tolterodine extended release (TER) or placebo once daily 4 hours or less before bed. Patients with eight or more micturitions/24 hours and a mean of 2.5 episodes/night or more were included. Changes in the number of nighttime and 24-hour micturitions were analyzed by urgency rating per micturition. The urgency per micturition was recorded in 7-day diaries using a 5-point rating scale (score 1 to 5). Each micturition was classified according to the following urgency rating categories: total (1 to 5), non-OAB (1 to 2), or OAB (3 to 5). OAB-related micturitions were further classified as nonsevere (score 3) and severe (score 4 to 5).


RESULTS
TER reduced the total number of nocturnal micturitions, but, compared with placebo, this difference was not statistically significant. However, TER did significantly reduce OAB-related and severe OAB-related nocturnal micturitions compared with placebo. TER had no effect on non-OAB micturitions. TER significantly reduced the total, OAB, and severe OAB micturitions during 24-hour and daytime intervals compared with placebo. Significantly more TER-treated than placebo-treated patients reported a treatment benefit and willingness to continue treatment. Adverse events associated with nighttime dosing of TER versus placebo were few.


CONCLUSIONS
TER significantly reduced OAB-related micturitions during 24-hour, daytime, and nighttime intervals. TER did not affect normal (non-OAB) micturitions. Nighttime dosing with TER was associated with few adverse events and adverse event-related withdrawals. The 24-hour efficacy of TER was maintained with nighttime dosing.
Rackley
Raymond
R
Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, Ohio, USA. rackler@ccf.org
Weiss
Jeffrey P
JP
Rovner
Eric S
ES
Wang
Joseph T
JT
Guan
Zhonghong
Z
D001559:Benzhydryl Compounds / Q000008:administration & dosage*; D003408:Cresols / Q000008:administration & dosage*; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage*; D010665:Phenylpropanolamine / Q000008:administration & dosage*; D000068737:Tolterodine Tartrate; D014549:Urinary Incontinence / Q000150:complications / Q000188:drug therapy*; D014555:Urination Disorders / Q000150:complications / Q000188:drug therapy
D001559:Benzhydryl Compounds; D003408:Cresols; D003692:Delayed-Action Preparations; D018727:Muscarinic Antagonists; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate