Pfizer drug effectively treats overactive bladder symptoms

Aug 21 2004

Women with mixed incontinence, a combination of overactive bladder and stress incontinence, reported a greater treatment benefit for overactive bladder symptoms from DETROL® LA (tolterodine tartrate extended release capsules) than placebo, according to new study results published in the August issue of Urology.

This is the first study of DETROL® LA in women with mixed incontinence, the most common type of urinary incontinence.

There is no treatment for mixed incontinence, so overactive bladder and stress incontinence are treated separately. The symptoms of overactive bladder include urgency (strong, sudden urges to urinate), frequency (often having to go to the bathroom more than eight times in 24 hours which may include getting up at night) and urgency incontinence (wetting accidents accompanied by a sudden and unstoppable urge to urinate). Stress incontinence is leakage of urine in response to activities that increase abdominal pressure, such as coughing, laughing, sneezing or lifting a heavy object.

"For patients with mixed incontinence, urge incontinence is often more bothersome than stress incontinence because it is associated with a greater loss of urine and is more unpredictable," said lead author Dr. Vik Khullar, senior lecturer and consultant urogynecologist in the department of obstetrics and gynecology at St Mary's Hospital, Imperial College, London. "In this study, first-line treatment with DETROL® LA significantly improved patients' overactive bladder symptoms in mixed incontinence. Treating overactive bladder first seems justified in women with mixed incontinence, given the profound impact OAB symptoms have on quality of life."

The double blind, randomized, placebo-controlled trial studied women (n=854) who experienced urgency, frequency and at least five episodes of urge incontinence per week in combination with stress incontinence. They received 8 weeks of treatment with DETROL® LA or placebo once a day.

Patients treated with DETROL® LA experienced a 77 percent reduction in weekly urge incontinence episodes, as compared to 51 percent for those receiving placebo. Patients treated with DETROL® LA also reported an overall reduction (37 percent versus 19 percent for placebo) in the number of urgency episodes in a 24-hour period.

After eight weeks, patients treated with DETROL® LA were nearly twice (1.9 times) as likely to report an improved bladder condition than patients receiving placebo, and a significantly higher proportion of DETROL® LA patients reported that treatment had been beneficial (76 percent versus 55 percent for placebo).

DETROL® LA is a once-daily medication with proven efficacy for 24 hours to help control the number and intensity of involuntary bladder muscle contractions that cause wetting accidents, and reduce the strong urinary urgency associated with overactive bladder.

Since its introduction in January 2001, DETROL® LA has become the number one prescribed treatment for overactive bladder in the United States and has been prescribed to more than 7 million patients worldwide. DETROL® LA is indicated for the treatment of overactive bladder with symptoms of urgency, urge incontinence, and frequency. An estimated 33 million people in the United States suffer from the symptoms of overactive bladder. DETROL® LA is not indicated for stress or mixed incontinence.

DETROL® LA is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma and in patients who have demonstrated hypersensitivity to the drug or its ingredients.

Patients with the following conditions should be treated with caution: renal impairment, bladder outflow obstruction, gastrointestinal obstructive disorders, controlled narrow-angle glaucoma, and significantly reduced hepatic function.

Dry mouth was the most frequently reported adverse event (DETROL® LA 23 percent vs. placebo 8 percent); others (more than or equal to 4 percent) included headache (DETROL® LA 6 percent vs. placebo 4 percent), constipation (DETROL® LA 6 percent vs. placebo 4 percent), and abdominal pain (DETROL® LA 4 percent vs. placebo 2 percent).