Flexible doses for managing overactive bladder

This study investigated the safety and effectiveness of fesoterodine (Toviaz) for the treatment of overactive bladder. The study concluded that fesoterodine was effective and well tolerated in patients with overactive bladder. 

Overactive bladder (OAB) is a condition associated with an increased urge to urinate. Patients with OAB may also experience urinary incontinence (inability to control urination). Medication can be prescribed to improve OAB symptoms. One type of treatment are anti-muscarinic medications. These drugs allow the bladder to relax, reducing the urge to urinate.

Fesoterodine is an anti-muscarinic drug. Fixed doses (4 mg and 8 mg) of fesoterodine can improve OAB symptoms, particularly quality of life scores. It is not clear if flexible doses of fesoterodine have any added benefit in the treatment of OAB.
 

This study investigated the safety and effectiveness of flexible doses of fesoterodine for the treatment of OAB. The study included 883 patients with OAB. Participants were randomly assigned to receive either fesoterodine (4 mg daily) or placebo (substance with no active effect) for 2 weeks. After 2 weeks, patients were given the option to increase their dose to 8 mg daily. The second phase of treatment lasted 10 weeks. Patients kept a record of bladder events (urinations, incontinence episodes) and OAB symptoms. 

Overall, fesoterodine treatment significantly reduced the number of urinations per day compared to placebo. There was also an improvement in the number of urgency episodes. Patients receiving active treatment consistently reported improved condition by week 2 of treatment, compared to placebo.

Of the 883 participants, 63% of the fesoterodine-treated patients, and 73% of placebo patients, opted for increasing treatment dose. By week 12, fesoterodine was superior than placebo in reducing urine frequency, urgency episodes, incontinence events and all patient questionnaire scales. Nighttime symptoms, however, were not affected by fesoterodine treatment compared to placebo.

The most common side effects reported with fesoterodine use were dry mouth (26%) and constipation (11%).  8% of participants received fesoterodine withdrew from the trial due to side effects. 

This study concluded that flexible dosed fesoterodine is effective and well tolerated in patients with overactive bladder.

This study included a higher proportion of women (83%) than men (17%).