Comparative efficacy and safety of transdermal oxybutynin and oral tolterodine versus placebo in previously treated patients with urge and mixed urinary incontinence.
OBJECTIVE
To compare the efficacy and safety of an oxybutynin transdermal delivery system (OXY-TDS) and oral, long-acting tolterodine (TOL-LA) with placebo in previously treated patients with urge or mixed urinary incontinence.


METHODS
After withdrawal of their current antimuscarinic therapy, 361 adult patients were randomized to 12 weeks of double-blind, double-dummy treatment with twice weekly OXY-TDS 3.9 mg/day, daily TOL-LA 4 mg, or placebo. Evaluations included change from baseline in patient urinary diary symptoms, incontinence-specific quality of life, and safety.


RESULTS
OXY-TDS 3.9 mg/day and TOL-LA 4 mg/day significantly reduced the number of daily incontinence episodes (median change -3 OXY-TDS and -3 TOL-LA versus -2 placebo; P <0.05), increased the average void volume (median change 24 and 29 mL versus 5.5 mL, P <0.01), and improved quality of life (incontinence impact questionnaire [IIQ] total score, P <0.05; Urogenital Distress Inventory Irritative Symptom subscale, P <0.05) compared with placebo. The most common adverse event for OXY-TDS was localized application site pruritus (14% versus 4% placebo) accompanied by a low incidence of systemic side effects (eg, dry mouth 4.1%). Anticholinergic adverse events occurred with greatest frequency during TOL-LA treatment (dry mouth 7.3% versus 1.7% placebo, P <0.05).


CONCLUSIONS
OXY-TDS and TOL-LA are effective and comparable treatments for patients with urge and mixed incontinence. OXY-TDS improves systemic safety with regard to anticholinergic side effects. Local skin irritation occurs in some OXY-TDS patients.
Dmochowski
Roger R
RR
Department of Urology, Vanderbilt University, Nashville, Tennessee, USA.
Sand
Peter K
PK
Zinner
Norman R
NR
Gittelman
Marc C
MC
Davila
G Willy
GW
Sanders
Steven W
SW
D000279:Administration, Cutaneous; D000284:Administration, Oral; D001559:Benzhydryl Compounds / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D003408:Cresols / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D003877:Dermatitis, Contact / Q000209:etiology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008333:Mandelic Acids / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000188:drug therapy*
D001559:Benzhydryl Compounds; D003408:Cresols; D008333:Mandelic Acids; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate; C005419:oxybutynin