Phase 4
N=566
A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder
Overactive Bladder
Bottom Line
View on ClinicalTrials.gov: NCT00928070 ↗Enrolled (actual)
566
Serious AEs
2.5%
Results posted
Jan 2013
Primary outcome: Primary: Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours — 3.93; 4.07 episodes per 24 hours
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Fesoterodine (Drug); Placebo (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours |
3.93; 4.07 | — |
| PRIMARY Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 |
-2.20; -2.84 | 0.0018 sig |
| SECONDARY Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 |
-1.54; -2.36 | 0.0003 sig |
| SECONDARY Percent Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12 |
-39.2; -57.2; -55.4; -71.2 | <0.0001 sig |
| SECONDARY Mean Number of Micturitions Per 24 Hours |
12.22; 12.11 | — |
| SECONDARY Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12 |
-0.77; -1.64; -1.50; -2.34 | 0.0003 sig |
| SECONDARY Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12 |
-5.1; -12.7; -10.4; -17.8 | <0.0001 sig |
| SECONDARY Mean Number of Micturition-related Urgency Episodes Per 24 Hours |
10.30; 10.02 | — |
| SECONDARY Change From Baseline in Mean Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12 |
-1.64; -2.74; -2.75; -4.15 | 0.0014 sig |
| SECONDARY Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12 |
-12.7; -26.2; -23.9; -39.7 | 0.0002 sig |
| SECONDARY Mean Number of Nocturnal Micturition-related Urgency Episodes Per 24 Hours |
2.87; 2.69 | — |
| SECONDARY Change From Baseline in Mean Number of Nocturnal Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12 |
-0.44; -0.58; -0.68; -0.97 | 0.2511 |
| SECONDARY Percent Change From Baseline in Nocturnal Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12 |
-4.9; -18.0; -15.5; -31.2 | 0.0010 sig |
| SECONDARY Frequency-Urgency Sum Rating Per 24 Hours |
45.33; 44.92 | — |
| SECONDARY Change From Baseline in Frequency-Urgency Sum Rating Per 24 Hours at Week 4 and 12 |
-6.95; -11.62; -11.53; -16.50 | 0.0001 sig |
| SECONDARY Change From Baseline in Mean Number of Protective Undergarments Changed Due to Urinary Leakage Per 24 Hours at Week 4 and 12 |
1.41; 1.49; 4.97; 4.81; 1.21; 1.35 | 0.0035 sig |
| SECONDARY Percentage of Participants With Change From Screening in Patient Perception of Bladder Condition (PPBC) at Week 4 and 12 |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | 0.0009 sig |
| SECONDARY Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score |
67.67; 67.25 | — |
| SECONDARY Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12 |
-13.81; -22.96; -20.48; -28.08 | <0.0001 sig |
| SECONDARY Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) |
45.89; 46.57; 44.72; 44.74; 40.19; 43.41 | — |
| SECONDARY Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12 |
12.35; 20.51; 12.90; 19.86; 13.33; 17.33 | <0.0001 sig |
| SECONDARY Overactive Bladder Satisfaction Questionnaire (OAB-S) Total Score on Satisfaction With OAB Control |
52.98; 68.89 | <0.0001 sig |
| SECONDARY Percentage of Participants With Overactive Bladder Satisfaction Questionnaire (OAB-S) Global Medication Satisfaction Question Response |
37.5; 18.9; 15.2; 9.3; 47.3; 71.8 | <0.0001 sig |
| SECONDARY Mini Mental State Examination (MMSE) |
28.04; 28.16 | — |
| SECONDARY Change From Screening in Mini Mental State Examination (MMSE) Score at Week 12 |
0.33; 0.15 | 0.2788 |
| SECONDARY Change From Baseline in Post Void Residual (PVR) Volume at Week 4 and 12 |
26.51; 25.69; 1.83; 13.43; -2.98; 13.58 | 0.0021 sig |
Summary
This study is designed to assess the efficacy and safety of a flexible dose regimen of fesoterodine on urgency urinary incontinence (UUI) episodes in vulnerable elderly subjects with overactive bladder (OAB).
Eligibility Criteria
Inclusion Criteria
- male or female subjects 65 years of age or older
- OAB symptoms for at least 3 months
- score 3 or greater on Vulnerable Elderly Survey (VES-13)
- adequate mobility for independent toileting
- mean number of at least 2 UUI episodes per 24 hours
- mean urinary frequency of 8 or more micturitions per 24 hours
- able to independently complete the bladder diaries
Exclusion Criteria
- PVR urinary volume greater than 200 ml
- MMSE score less than 20
- greater than 15 UUI episodes per 24 hours
- creatinine clearance less than 30 ml/min
- an average resting heart rate of greater than or equal to 90 beats per minute
Data sourced from ClinicalTrials.gov (NCT00928070). 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.