Comparative efficacy and safety of transdermal oxybutynin and oral tolterodine versus placebo in previously treated patients with urge and mixed urinary incontinence

• Published in: Urology (Ridgewood, N.J.) Vol. 62; no. 2; pp. 237 - 242
• Main Authors: Dmochowski, Roger R, Sand, Peter K, Zinner, Norman R, Gittelman, Marc C, Davila, G.Willy, Sanders, Steven W
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.08.2003; Elsevier Science
• Subjects: Administration, Cutaneous; Administration, Oral; Benzhydryl Compounds - administration & dosage; Benzhydryl Compounds - adverse effects; Benzhydryl Compounds - therapeutic use; Biological and medical sciences; Cresols - administration & dosage; Cresols - adverse effects; Cresols - therapeutic use; Dermatitis, Contact - etiology; Double-Blind Method; Female; Humans; Male; Mandelic Acids - administration & dosage; Mandelic Acids - adverse effects; Mandelic Acids - therapeutic use; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Phenylpropanolamine; Tolterodine Tartrate; Treatment Outcome; Urinary Incontinence, Stress - drug therapy; Urinary system; Human; Urinary system disease; Transdermal system; Toxicity; Treatment efficiency; Oral administration; Tolterodine; Urinary tract disease; Urinary incontinence; Voiding dysfunction; Chemotherapy; Treatment; Antispasmodic agent; Bladder disease; Oxybutynin; Muscarinic receptor; Antagonist; Comparative study
• ISSN: 0090-4295; 1527-9995
• DOI: 10.1016/S0090-4295(03)00356-X

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. 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. 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). 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.