Effects of flexible-dose fesoterodine on overactive bladder symptoms and treatment satisfaction: an open-label study

Abstract

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 (> or = 8 micturitions and > or = 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 > or = 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.

Trial registration: ClinicalTrials.gov NCT00425100.

Figures

Figure 1

Subject disposition

Figure 2

Number of (A) micturitions, (B) UUI episodes (for subjects reporting > 0 UUI episodes at baseline), (C) urgency episodes, (D) nocturnal micturitions, (E) severe urgency episodes (for subjects reporting > 0 severe urgency episodes at baseline) and (F) frequency-urgency sum per 24 h at baseline and at 12 weeks of fesoterodine treatment. Data shown are mean ± standard deviation. UUI = urgency urinary incontinence. *p

Figure 4

Response distribution on the PPBC questionnaire at baseline and after 12 weeks of fesoterodine treatment. PPBC = Patient Perception of Bladder Condition

Figure 3

Percentage of subjects reporting Treatment Satisfaction with prior treatment (baseline) or current treatment (week 12)

Figure 5

Response distribution on the UPS at baseline and after 12 weeks of fesoterodine treatment. UPS = Urgency Perception Scale

Figure 6

Overactive Bladder Questionnaire (OAB-q) scores for total HRQL, the four HRQL domains, and Symptom Bother are shown at baseline and after 12 weeks of fesoterodine treatment. A positive score change in total HRQL and its domains indicates improvement; a negative score change in Symptom Bother indicates improvement. HRQL = health-related quality of life. *p