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Safety and efficacy of flexible-dose fesoterodine in British subjects with overactive bladder: insights into factors associated with dose escalation

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Abstract

Introduction and hypothesis

This study evaluated the efficacy and safety of flexible-dose fesoterodine and factors associated with dose escalation in subjects with overactive bladder (OAB).

Methods

In this 12-week, open-label study, 331 adults with OAB symptoms for ≥3 months, ≥8 micturitions and ≥3 urgency episodes per 24 h and who reported at least “some moderate” bladder-related problems were treated with fesoterodine 4 mg once daily for 4 weeks, with the option to escalate to 8 mg for the remaining 8 weeks based on discussion of efficacy and tolerability with the investigator. Factors influencing dose escalation were identified using stepwise logistic regression. Efficacy was assessed via 3-day bladder diaries and patient-reported outcomes.

Results

Of the subjects, 59 % dose escalated at week 4; 93 % of escalators cited insufficient clinical response. The decision to escalate was most often made by the subject (alone or with the investigator). Improvements from baseline were observed in diary and patient-reported outcomes at weeks 4 and 12. Smaller improvements in micturition frequency and worse bladder-related problems at week 4 were significantly associated with increased likelihood of dose escalation; baseline micturition frequency, age, sex, body mass index, antimuscarinic-associated adverse events and OAB symptom duration were not. Non-escalators had greater improvement from baseline to week 4 than escalators; by week 12, improvement was similar among escalators and non-escalators. Fesoterodine was well tolerated.

Conclusions

Treatment with flexible-dose fesoterodine improved bladder diary and patient-reported outcomes. Lower clinical response was related to dose escalation; after escalation, response in escalators approached that of non-escalators.

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Abbreviations

AE:

Adverse event

BMI:

Body mass index

BSW:

Benefit, Satisfaction and Willingness to Continue

CI:

Confidence interval

ICIQ-SF:

International Consultation on Incontinence Questionnaire–Short Form

OAB:

Overactive bladder

PPBC:

Patient Perception of Bladder Condition

SAE:

Serious adverse event

SAGA:

Self-Assessment of Goal Achievement

SD:

Standard deviation

TSQ:

Treatment Satisfaction Questionnaire

UPS:

Urgency Perception Scale

UUI:

Urgency urinary incontinence

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Acknowledgments

This study was sponsored by Pfizer Ltd. Medical writing assistance was provided by Patricia B. Leinen, Ph.D., and Colin P. Mitchell, Ph.D., from Complete Healthcare Communications, Inc. and was funded by Pfizer Ltd.

Conflicts of interest

LC received funding during the preceding year for research, lecturing, or consultancies from Astellas and Pfizer and has done research consultancy or advisory work for Astellas, Pfizer, Ethicon, TEVA, Merck, and Eli Lilly. TH, JR, and AW have received research monies, honoraria, or consultancy fees from Pfizer, Astellas, Watson Pharma, and Orion Pharma. CEB is an employee of Pfizer France. AD is an employee of Pfizer Ltd. IK was an employee of Pfizer Ltd at the time this study was conducted.

Author information

Authors and Affiliations

  1. King’s College Hospital, 8 Devonshire Place, London, W1G 6HP, UK

    Linda Cardozo

  2. Knowle House Surgery, Devon, UK

    Timothy Hall

  3. The Alverton Practice, Cornwall, UK

    John Ryan

  4. Pfizer France, Paris, France

    Caty Ebel Bitoun

  5. Pfizer Ltd, Walton Oaks, UK

    Imran Kausar & Amanda Darekar

  6. University of Alberta, Edmonton, AB, Canada

    Adrian Wagg

Authors
  1. Linda Cardozo
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  2. Timothy Hall
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  3. John Ryan
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  4. Caty Ebel Bitoun
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  5. Imran Kausar
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  6. Amanda Darekar
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  7. Adrian Wagg
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Corresponding author

Correspondence to Linda Cardozo.

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Cardozo, L., Hall, T., Ryan, J. et al. Safety and efficacy of flexible-dose fesoterodine in British subjects with overactive bladder: insights into factors associated with dose escalation. Int Urogynecol J 23, 1581–1590 (2012). https://doi.org/10.1007/s00192-012-1804-1

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  • DOI: https://doi.org/10.1007/s00192-012-1804-1

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