Local, Open-Label, Extension Trial Of The Efficacy And Safety Of Fesoterodine In Elderly Patients With Overactive Bladder
- Registration Number
- NCT01054222
- Lead Sponsor
- Pfizer
- Brief Summary
This is an open-label extension study intended for subjects who have previously completed study A0221045 (fesoterodine in elderly OAB patients) and who have been recommended by the investigator as being suitable for the extended use of Fesoterodine. Data from this study will extend the evaluation of efficacy, tolerability and safety of Fesoterodine in older subjects from Portugal.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
- Subjects must have previously completed fesoterodine study A0221045 [in Portugal]
- Subjects must be recommended for inclusion by the investigator
- Conditions or states excluding use of fesoterodine e.g. contraindication to fesoterodine
- Predominant stress incontinence as determined by the investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fesoterodine 4 mg Fesoterodine Dose determined as per previous drug regime in A0221045 and investigator's evaluation. Fesoterodine 8 mg Fesoterodine Dose determined as per previous drug regime in A0221045 and investigator's evaluation.
- Primary Outcome Measures
Name Time Method Mean Number of Micturition-Related Urgency Episodes Per 24 Hours (End of Treatment [EOT]) End of Treatment (up to Week 82) The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with Urinary Sensation Scale (USS) rating of greater than or equal to (\>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
- Secondary Outcome Measures
Name Time Method Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale \[(Actual total raw score - lowest possible value of raw score)/range\]\*100. Higher scores values indicative of greater symptom bother.
Mean Number of Micturition-Related Urgency Episodes Per 24 Hours Baseline, Month 3, 6, 9, 12, 15, 18 The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) The mean number of severe micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (\>=) 4 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Mean Number of Micturitions Per 24 Hours Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Mean Number of Nocturnal Micturitions Per 24 Hours Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.
Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Daily Sum Rating on the Urinary Sensation Scale (USS) Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) The daily sum rating was calculated as the mean rating score on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Numerical decrease indicates improvement.
Percentage of Incontinent Participants at Baseline Baseline UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Percentage of Participants With No Urgency Urinary Incontinence (UUI) Episode Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) The mean number of urinary incontinence pads (IP), barrier creams (BC) and powder used per 24 hours is calculated as the total number of IP, BC and powder used divided by the total number of diary days collected at that visit.
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Month 3,6,9,12,15,18, and End of Treatment Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference less than \[\<\]0).
Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Months 3,6,9,12,15,18, and End of Treatment Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) PPUS: self-administered, single-item, questionnaire that measured the participant's perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Score of 0 (usually not able to hold urine), 1 (usually able to hold urine \[without leaking\] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet \[without leaking\]). Change = observation minus baseline. Deterioration: negative difference of scores; improvement: increase of 1 or more points in difference of scores, relative to baseline.
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = \[(Highest possible raw score-Actual total raw score)/Raw score range\]\*100. Higher transformed scores indicative of better HRQL.
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b) Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (EOT) (Week 82) OAB-s assessed OAB medication expectations, daily life with OAB, and satisfaction with OAB medication. Question (Q) 5 evaluates OAB medication expectations (exceeds/meets or does not meet expectation). Q9 to 11 assessed satisfaction with OAB medication's ability to allow reaching bathroom without urine loss (Q9), decrease: sudden urgencies to urinate (Q10a), urine loss due to urgency (Q10b), waking up at night to urinate (Q10c) and urination during day (Q10d), and improve control of urine loss (Q11a) and need to urinate (Q11b). Q9 to 11 were answered as 'very satisfied', 'somewhat satisfied', 'neither dissatisfied nor satisfied', 'somewhat dissatisfied', and 'very dissatisfied'. The results for Q9 to 11 are reported as "satisfied" (participants who answered 'very satisfied' or 'somewhat satisfied' for all 7 questions) or "not satisfied" (participants who answered 'neither dissatisfied nor satisfied' or 'somewhat dissatisfied' or 'very dissatisfied' for all 7 questions).
King's Health Questionnaire (KHQ) Domain Scores Baseline, End of Treatment (EOT) (Week 82) KHQ: self-administered questionnaire contained 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, and severity of urinary symptoms). Each domain score ranged: 0-100, where 0=best outcome/response and 100=worst outcome/response.
Trial Locations
- Locations (3)
Hospital Ordem do Carmo
🇵🇹Porto, Portugal
Hospital de São João
🇵🇹Porto, Portugal
Centro de Avaliação Geriátrica
🇵🇹Lisboa, Portugal