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


CONCLUSIONS
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.
Department of Urology, Universiteit en Universitair Ziekenhuis Antwerpen, Antwerp, Belgium. wyndaelejj@skynet.be
J J
JJ
Wyndaele
E R
ER
Goldfischer
J D
JD
Morrow
J
J
Gong
L J
LJ
Tseng
Z
Z
Guan
M S
MS
Choo
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016587:Antimutagenic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001559:Benzhydryl Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D008499:Medical Records; D008875:Middle Aged; D017060:Patient Satisfaction; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000150:complications / Q000188:drug therapy*; D053202:Urinary Incontinence, Urge / Q000188:drug therapy* / Q000209:etiology; D014554:Urination; D055815:Young Adult
D016587:Antimutagenic Agents; D001559:Benzhydryl Compounds; C526675:fesoterodine