Disclosures Jean-Jacques Wyndaele – Pfizer consultant, Honoraria from speaking at Pfizer sponsored meeting. Evan R. Goldfischer – Pfizer investigator, Pfizer lecturer. Jon D. Morrow – employee of Pfizer Inc. Jason Gong – employee of Pfizer Inc. Li-Jung Tseng – employee of Pfizer Inc. Zhonghong Guan – employee of Pfizer Inc. Myung-Soo Choo – no conflicts.
Effects of flexible-dose fesoterodine on overactive bladder symptoms and treatment satisfaction: an open-label study
Version of Record online: 3 MAR 2009
© 2009 The Authors. Journal compilation © 2009 Blackwell Publishing Ltd
International Journal of Clinical Practice
Volume 63, Issue 4, pages 560–567, April 2009
How to Cite
Wyndaele, J.-J., Goldfischer, E. R., Morrow, J. D., Gong, J., Tseng, L.-J., Guan, Z. and Choo, M.-S. (2009), Effects of flexible-dose fesoterodine on overactive bladder symptoms and treatment satisfaction: an open-label study. International Journal of Clinical Practice, 63: 560–567. doi: 10.1111/j.1742-1241.2009.02035.x
Clinicaltrialregistration This trial has been registered at clinicaltrials.gov (Unique ID# NCT00425100).
Clinicaltrialdataposting Results of this trial have been posted at Clinical StudyResults.org (Unique ID# NCT00425100; Protocol# A0221007).
Re-use of this article is permitted in accordance with the Creative Commons Deed, Attribution 2.5, which does not permit commercial exploitation.
- Issue online: 16 MAR 2009
- Version of Record online: 3 MAR 2009
- Paper received January 2009, accepted February 2009
Aims: To evaluate the efficacy and tolerability of flexible-dose fesoterodine in subjects with overactive bladder (OAB) who were dissatisfied with previous tolterodine treatment.
Methods: This was a 12-week, open-label, flexible-dose study of adults with OAB (≥ 8 micturitions and ≥ 3 urgency episodes per 24 h) who had been treated with tolterodine (immediate- or extended-release) for OAB within 2 years of screening and reported dissatisfaction with tolterodine treatment. Subjects received fesoterodine 4 mg once daily for 4 weeks; thereafter, daily dosage was maintained at 4 mg or increased to 8 mg based on the subject’s and physician’s subjective assessment of efficacy and tolerability. Subjects completed 5-day diaries, the Patient Perception of Bladder Condition (PPBC) and the Overactive Bladder Questionnaire (OAB-q) at baseline and week 12 and rated treatment satisfaction at week 12 using the Treatment Satisfaction Question (TSQ). Safety and tolerability were assessed.
Results: Among 516 subjects treated, approximately 50% opted for dose escalation to 8 mg at week 4. Significant improvements from baseline to week 12 were observed in micturitions, urgency urinary incontinence episodes, micturition-related urgency episodes and severe micturition-related urgency episodes per 24 h (all p < 0.0001). Approximately 80% of subjects who responded to the TSQ at week 12 reported satisfaction with treatment; 38% reported being very satisfied. Using the PPBC, 83% of subjects reported improvement at week 12 with 59% reporting improvement ≥ 2 points. Significant improvements from baseline (p < 0.0001) exceeding the minimally important difference (10 points) were observed in OAB-q Symptom Bother and Health-Related Quality of Life (HRQL) scales and all four HRQL domains. Dry mouth (23%) and constipation (5%) were the most common adverse events; no safety issues were identified.
Conclusion: Flexible-dose fesoterodine significantly improved OAB symptoms, HRQL, and rates of treatment satisfaction and was well tolerated in subjects with OAB who were dissatisfied with prior tolterodine therapy.