Tolterodine ER Reduces All Overactive Bladder Symptoms

Main Category: Urology / Nephrology
Article Date: 07 Apr 2006 - 0:00 PDT

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The extended-release (ER) formulation of tolterodine (DETROL LA/DETRUSITOL SR) is an effective treatment for all overactive bladder (OAB) symptoms, according to data presented at the 21st Congress of the European Association of Urology (EAU).

Importantly, the results also show that the medication significantly reduces patients' most bothersome symptom, whether it is urgency, daytime frequency, nocturnal frequency, or urgency urinary incontinence (UUI). Patients treated with tolterodine ER had a decrease in symptom bother score of 63 percent and a 52 percent increase in their health-related quality of life score.

The findings are from the IMprovement in Patients: Assessing symptomatic Control with Tolterodine ER (IMPACT) trial.

"Outcomes related to specific OAB symptoms are important because patients do not necessarily experience all symptoms and are not bothered by each symptom to the same degree," IMPACT investigator Victor Elinoff, MD, research director at the Regional Clinical Research, Inc. in Endwell, NY said.

For the trial, the researchers assessed the efficacy of 12 weeks' treatment with tolterodine, 4 mg/d, for treating patients' most bothersome OAB symptom.

The 896 participants in the study were seen at US primary care and gynecology practices and had OAB symptoms for at least three months and reported being at least "moderately bothered" by their most bothersome OAB symptom as indicated by the patient- completed OAB Bother Rating Scale.

At the start of treatment and at weeks four and 12, the data from a three-day urinary journal maintained by patients were evaluated along with patient perception of bladder condition questionnaire (PPBC), symptom bother and health-related quality of life questionnaire (OAB-q).

Results showed that tolterodine ER significantly reduced patients' most bothersome OAB symptom. Overall, incontinence episodes were decreased by 80 percent, urgency by 78 percent, daytime frequency by 30 percent, and nighttime frequency by 40 percent.

At the 12th week, some improvement in overall bladder condition as measured by the PPBC was experienced by 86 percent of the urgency group, 79 percent of the nocturnal frequency group, 78 percent of the daytime frequency group, and 75 percent of the urgency urinary incontinence group.

In addition, week 12 changes from baseline in PAB symptoms significantly correlated with changes in PPBC (r= 0.26 -0.36, p less than 0.001) and symptom bother and health-related quality of life (r-0.24 - 0.51, p less than 0.001).

"These observations confirm the relevance of these patient-reported outcomes in OAB," IMPACT co-investigator Karin S. Coyne, PhD, a researcher at MEDTAP International in Bethesda, Maryland, said.

Tolterodine ER was associated with a low rate of adverse events.

Elsewhere at the meeting, researchers announced the launch of the Add-on study of tolterodine ER in Alpha-blockers in Men with persistent OAB symptoms (ADAM). The study will test the efficacy and safety of tolterodine versus placebo as add-on therapy in men with persistent OAB symptoms of urgency and frequency, with or without urgency incontinence, while on treatment with alpha blockers. The EPIC study, also presented at the EAU, found that over half of adult men report at least one lower urinary tract symptom and that the prevalence of lower urinary tract symptoms increases with age, particularly over age 60.

Written by Jill Stein
Jill Stein is a Paris-based freelance medical writer.