Prospective randomized controlled trial of extended-release oxybutynin chloride and tolterodine tartrate in the treatment of overactive bladder: results of the OBJECT Study.
OBJECTIVE
To compare the efficacy and tolerability of extended-release oxybutynin chloride and tolterodine tartrate at 12 weeks in participants with overactive bladder.


METHODS
The OBJECT (Overactive Bladder: Judging Effective Control and Treatment) study was a prospective, randomized, double-blind, parallel-group study conducted between March and October 2000 at 37 US study sites. Participants who had between 7 and 50 episodes of urge incontinence per week and 10 or more voids in 24 hours received extended-release oxybutynin, 10 mg/d, or tolterodine, 2 mg twice daily. The outcome measures were the number of episodes of urge incontinence, total incontinence, and micturition frequency at 12 weeks adjusted for baseline.


RESULTS
A total of 315 women and 63 men were randomized and treated, and 332 participants (276 women, 56 men) completed the study. At the end of the study, extended-release oxybutynin was significantly more effective than tolterodine in each of the main outcome measures: weekly urge incontinence (P=.03), total incontinence (P=.02), and micturition frequency episodes (P=.02) adjusted for baseline. Both drugs improved symptoms of overactive bladder significantly from baseline to the end of the study as assessed by the 3 main outcome measures (P<.001). Dry mouth, the most common adverse event, was reported by 28.1% and 33.2% of participants taking extended-release oxybutynin and tolterodine, respectively (P=.32). Rates of central nervous system and other adverse events were low and similar in both groups.


CONCLUSIONS
Extended-release oxybutynin was more effective than tolterodine as measured by end-of-study urge incontinence, total incontinence, and micturition frequency episodes. Both groups had similar rates of dry mouth and other adverse events.
Appell
R A
RA
Cleveland Clinic Foundation, Ohio, USA. rappell@www.urol.bcm.tmc.edu
Sand
P
P
Dmochowski
R
R
Anderson
R
R
Zinner
N
N
Lama
D
D
Roach
M
M
Miklos
J
J
Saltzstein
D
D
Boone
T
T
Staskin
D R
DR
Albrecht
D
D
D000368:Aged; D001559:Benzhydryl Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D003408:Cresols / Q000008:administration & dosage* / Q000009:adverse effects; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008333:Mandelic Acids / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D009422:Nervous System Diseases / Q000139:chemically induced; D010665:Phenylpropanolamine; D011336:Probability; D011446:Prospective Studies; D012016:Reference Values; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D013644:Tartrates / Q000008:administration & dosage* / Q000009:adverse effects; D000068737:Tolterodine Tartrate; D016896:Treatment Outcome; D001750:Urinary Bladder, Neurogenic / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D014550:Urinary Incontinence, Stress / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D014555:Urination Disorders / Q000175:diagnosis / Q000188:drug therapy / Q000209:etiology; D014987:Xerostomia / Q000139:chemically induced
D001559:Benzhydryl Compounds; D003408:Cresols; D003692:Delayed-Action Preparations; D008333:Mandelic Acids; D018727:Muscarinic Antagonists; D013644:Tartrates; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate; C005419:oxybutynin