Effect of fesoterodine 4 mg on bladder diary and patient-reported outcomes during the first week of treatment in subjects with overactive bladder

Abstract

Objective:

To assess the onset of efficacy of fesoterodine 4 mg versus placebo in subjects with overactive bladder (OAB) symptoms

Research design and methods:

Subjects who reported OAB symptoms for ≥3 months and recorded ≥8 micturitions and ≥1 urgency urinary incontinence (UUI) episode per 24 hours in 3-day baseline diaries were randomized to fesoterodine 4 mg, tolterodine extended release (ER) 4 mg, or placebo. This is an analysis of first week data from a 12-week, double-blind trial.

Main outcome measures:

Baseline to week 1 changes in 3-day bladder diary variables, Patient Perception of Bladder Condition (PPBC), and Urgency Perception Scale (UPS) scores reported by subjects receiving fesoterodine 4 mg or placebo.

Results:

By week 1, fesoterodine 4 mg (n = 679) was associated with significantly greater improvements compared with placebo (n = 334) in micturitions, urgency, severe urgency and UUI episodes, frequency-urgency sum, and MVV per 24 hours and 3-day diary-dry rate (all p < 0.05), but not nocturnal micturitions per 24 hours (p = 0.273). These differences were significant as early as day 5 of treatment (i.e., day 1 of the 3-day diary) for all diary endpoints except nocturnal micturitions and MVV. Changes in PPBC scores were significantly more favorable with fesoterodine 4 mg versus placebo (p = 0.0143); changes in UPS scores were not significantly different (p = 0.077).

Conclusion:

The results provide evidence that patients receiving fesoterodine 4 mg for their OAB symptoms may expect to experience a response as early as 1 week after initiating treatment. One limitation is that, although 65% of subjects had received treatment with antimuscarinics before the study, whether subjects were dissatisfied with previous treatment and reasons for dissatisfaction were not collected. This might affect the magnitude of outcome improvements. Also, it is not known whether the UPS is sensitive enough to detect treatment differences as early as week 1.

Trial registration: ClinicalTrials.gov identifier: NCT00444925.

Key words::

• Comparative effectiveness research
• Fesoterodine
• Muscarinic antagonist
• Tolterodine
• Treatment outcome

Transparency

Declaration of funding:

Funding for this study was provided by Pfizer Inc.

Declaration of financial/other relationships

J.C. is a consultant and investigator for Pfizer Inc, Astellas Pharma, Inc, Allergan, Inc, Johnson & Johnson, Inc, and Paladin Labs Inc. J.C.A. has no disclosures. A.D.G. is a consultant and speaker for Covidien and a speaker for Astellas and Pfizer Inc. M.C., J.G., and Z.G. are employees of Pfizer Inc. and hold stock in the company. CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgments

Editorial assistance was provided by Simon J. Slater, PhD, and Colin P. Mitchell, PhD, from Complete Healthcare Communications, Inc., and was funded by Pfizer Inc.