Details

Autor(en) / Beteiligte

• Appell, Rodney A.
• Sand, Peter
• Dmochowski, Roger
• Anderson, Rodney
• Zinner, Norman
• Lama, Daniel
• Roach, Martha
• Miklos, John
• Saltzstein, Daniel
• Boone, Timothy
• Staskin, David R.
• Albrecht, Detlef

Titel

Prospective Randomized Controlled Trial of Extended-Release Oxybutynin Chloride and Tolterodine Tartrate in the Treatment of Overactive Bladder: Results of the OBJECT Study

Ist Teil von

• Mayo Clinic proceedings, , Vol.76 (4), p.358-363

Ort / Verlag

Elsevier Inc

Link zum Volltext

Quelle

Alma/SFX Local Collection

Beschreibungen/Notizen

• To compare the efficacy and tolerability of extended-release oxybutynin chloride and tolterodine tartrate at 12 weeks in participants with overactive bladder. 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. 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. 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.