Evaluation of a new once-daily formulation of oxybutynin for the treatmentof urinary urge incontinence

Objectives. To evaluate in a 16-center, single-treatment study once-daily c ontrolled-release oxybutynin (Ditropan XL) for urinary urge incontinence. Methods. Two hundred fifty-six participants with urge incontinence or mixed incontinence with a significant urge component were treated. After baselin e measurements, participants converting from conventional oxybutynin starte d Ditropan XL at their previous oxybutynin dose; others started at 5 mg/day . Doses were adjusted until participants reached a maintenance dose that pr oduced continence or the best balance between continence and side effects. This dose was continued for 12 weeks. Effectiveness was assessed by urinary diaries. Results. Effectiveness was achieved across all doses studied (5 to 30 mg/da y), with 70.8% of participants using maintenance doses of 5 to 15 mg/day. M ean urge incontinence episodes per week decreased from 18.8 at baseline to 3.9 in maintenance week 1, 2.7 in week 4, and 2.8 at the end of the study. For those participants who reported urge incontinence episodes at baseline but were free of urge incontinence at maintenance week 1, 51% remained free of urge incontinence at every subsequent assessment. Participants who conv erted from other medications showed symptomatic improvement after conversio n. At some time during the study, 58.6% of participants reported dry mouth, with 23.0% of participants rating it moderate or severe. Only 1.6% of part icipants discontinued the medication because of dry mouth. Conclusions. Ditropan XL treatment reduced the number of incontinence episo des. Maximum benefit was demonstrated by maintenance week 4 and was sustain ed through 12 weeks of maintenance th era py. (C) 1999, Elsevier Science In c.