Clinical trial NCT01054222: Local, Open-Label, Extension Trial Of The Efficacy And Safety Of Fesoterodine In Elderly Patients With Overactive Bladder
Official title: A Local, Multicentre, Open-Label, Extension Trial To Evaluate The Efficacy And Safety Of Fesoterodine Flexible Dose Regimen In Elderly Patients With Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Bladder, Overactive
Keywords: overactive bladder idiopathic
elderly fesoterodine SOFIA Portugal extension study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-01-22
Enrollment: 31
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Subjects must have previously completed fesoterodine study A0221045 \[in Portugal\]
* Subjects must be recommended for inclusion by the investigator

Exclusion Criteria:

* Conditions or states excluding use of fesoterodine e.g. contraindication to fesoterodine
* Predominant stress incontinence as determined by the investigator

Primary outcomes:
measure: Mean Number of Micturition-Related Urgency Episodes Per 24 Hours (End of Treatment [EOT])
timeFrame: End of Treatment (up to Week 82)
Secondary outcomes:
measure: Mean Number of Micturition-Related Urgency Episodes Per 24 Hours
timeFrame: Baseline, Month 3, 6, 9, 12, 15, 18
measure: Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours
timeFrame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)
measure: Mean Number of Micturitions Per 24 Hours
timeFrame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)
measure: Mean Number of Nocturnal Micturitions Per 24 Hours
timeFrame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)
measure: Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
timeFrame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)
measure: Daily Sum Rating on the Urinary Sensation Scale (USS)
timeFrame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)
measure: Percentage of Incontinent Participants at Baseline
timeFrame: Baseline
measure: Percentage of Participants With No Urgency Urinary Incontinence (UUI) Episode
timeFrame: Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)
measure: Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours
timeFrame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)
measure: 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
timeFrame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)
measure: 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
timeFrame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)
measure: Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
timeFrame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)
measure: Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
timeFrame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)
measure: Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
timeFrame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (EOT) (Week 82)
measure: King's Health Questionnaire (KHQ) Domain Scores
timeFrame: Baseline, End of Treatment (EOT) (Week 82)
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Centro de Avaliação Geriátrica
city: Porto
country: Portugal
facility: Hospital Ordem do Carmo
city: Porto
country: Portugal
facility: Hospital de São João
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: