Rx Reduced Bladder Leakage in the Elderly

Fesoterodine decreased urgent incontinence episodes in the elderly

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) People with urgency incontinence get a signal that they have to urinate moments before they have bladder leakage. Getting relief from this tough problem is on the mind of many seniors.

Urgency incontinence has serious health and social impacts on the elderly and is associated with falls, depression and increased risk for hospitalization.

Protective and absorbent garments help, but prevention is the goal of current research.

Recently, a study sponsored by Pfizer, makers of fesoterodine (brand name Toviaz), demonstrated that the medication significantly improved urgency urinary incontinence (UUI) in the elderly.

"Explore options for treating incontinence with your doctor."

Catherine E. DuBeau, MD, from the UMass Medical School in Worcester, Massachusetts, and a team of researchers ran this clinical trial on Pfizer’s medication, fesoterodine.

Men and women over age 65 who had symptoms of UUI for three or more months, with an average of two to 15 episodes of UUI and eight or more leakages in 24 hours were recruited into the study.

The study subjects were divided into two groups of 281 people each. One group was given 4 mg per day of fesoterodine and one group was given a placebo (fake medication).

At the end of four weeks, the fesoterodine group could increase their dose to 8 mg after a consultation with their doctor. Patients on placebo could also request a dose increase, but were still given a placebo. The study medication or placebo was taken for a total of 12 weeks.

Patients kept diaries of their UUI symptoms and leakage events.

Results of the study showed that people who took fesoterodine had significantly fewer UUI episodes in 24 hours, a higher dry rate and less leakage events than the people in the placebo group.

Both groups started the study with about four UUI episodes and 12 leaks per day. At the end of 12 weeks, participants taking fesoterodine reported almost three fewer UUI episodes per day and two fewer leaks per day than at the start of the study.

Analysis of the diaries showed that 50 percent of the patients who took fesoterodine had a dry day by 12 weeks, compared with 17 percent who took placebo.

Nighttime leaks were not significantly changed in either group compared to the number of leaks subjects reported at the start of the study.

Some subjects left the study due to adverse events. The researchers did not consider these events to be related to the study medication. A total of 26 people in the group taking fesoterodine and 14 in the placebo group experienced adverse events.

Most of the people who reported an adverse event had mild to moderate dry mouth and constipation. These events were reported in each group, but were significantly higher in the fesoterodine group.

Dr. DuBeau and team mentioned that their study had some limitations. One was that the participants were not a diverse group; 82 percent of the participants were women, 86 percent were white and 50 percent were over 75. These researchers also noted that since their study required subjects to keep diaries, their study population did not include people with memory or other mental processing problems.

One unique aspect of this study, noted by the authors, was that their study was done in a group of people similar to those seen in medical practices specializing in care of the elderly.

“These results provide important evidence that medically complex elderly individuals with UUI benefit significantly and broadly from treatment with fesoterodine,” the authors of the study concluded.

The cost of 30 8-mg tablets of Toviaz usually runs about $200.

This clinical trial was published in the February issue of The Journal of Urology.

Support for this study was provided by Pfizer.

Dr. DuBeau disclosed that she had a financial or other relationship with Pfizer and the American Geriatrics Society, among others.

Review Date: 
February 21, 2014
Last Updated:
February 22, 2014