Phase 4
Completed N=31
Local, Open-Label, Extension Trial Of The Efficacy And Safety Of Fesoterodine In Elderly Patients With Overactive Bladder
Urinary Bladder, Overactive
Source: ClinicalTrials.gov NCT01054222 ↗
Enrolled (actual)
31
Serious AEs
3.2%
Results posted
May 2013
Primary outcomePrimary: Mean Number of Micturition-Related Urgency Episodes Per 24 Hours (End of Treatment [EOT]) — 5.48 episodes per 24 hours
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Number of Micturition-Related Urgency Episodes Per 24 Hours (End of Treatment [EOT]) |
5.48 | — |
| SECONDARY Mean Number of Micturition-Related Urgency Episodes Per 24 Hours |
10.49; 5.28; 6.37; 4.98; 5.15; 5.09 | — |
| SECONDARY Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours |
6.35; 3.36; 2.40; 2.52; 2.23; 2.67 | — |
| SECONDARY Mean Number of Micturitions Per 24 Hours |
13.44; 10.97; 10.98; 10.44; 10.51; 10.67 | — |
| SECONDARY Mean Number of Nocturnal Micturitions Per 24 Hours |
3.45; 3.08; 3.25; 3.07; 2.88; 3.00 | — |
| SECONDARY Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours |
2.64; 2.27; 1.54; 1.36; 1.29; 1.83 | — |
| SECONDARY Daily Sum Rating on the Urinary Sensation Scale (USS) |
45.63; 31.60; 31.39; 28.29; 27.63; 28.67 | — |
| SECONDARY Percentage of Incontinent Participants at Baseline |
58.1 | — |
| SECONDARY Percentage of Participants With No Urgency Urinary Incontinence (UUI) Episode |
81.3; 77.8; 77.8; 77.8; 64.7; 66.7 | — |
| SECONDARY Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours |
3.69; 0.48; 0.24; 3.15; 0.79; 0.19 | — |
| SECONDARY 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 |
0; 2; 11; 11; 4; 0 | — |
| SECONDARY 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 |
3; 12; 13; 5; 17; 5 | — |
| SECONDARY Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score |
35.54; 33.29; 32.95; 33.93; 29.55; 31.30 | — |
| SECONDARY Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) |
77.77; 78.28; 77.14; 79.55; 76.70; 74.54 | — |
| SECONDARY Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b) |
22; 4; 22; 5; 25; 3 | — |
| SECONDARY King's Health Questionnaire (KHQ) Domain Scores |
43.75; 38.75; 50.62; 41.67; 31.48; 35.00 | — |
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
Data sourced from ClinicalTrials.gov (NCT01054222). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.