Phase 4
Completed N=794
A Study to Compare the Effectiveness and Safety of Fesoterodine and Placebo in an Elderly Population of Patients Who go to the Toilet Very Frequently Due to Overactive Bladder.
Urinary Bladder, Overactive
Source: ClinicalTrials.gov NCT00798434 ↗
Enrolled (actual)
794
Serious AEs
2.9%
Results posted
Dec 2011
Primary outcomePrimary: Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12 — 8.80; 8.48; -2.48; -3.84 Episodes per 24 hours — p=<0.0001
Summary
The drug being studied, fesoterodine fumarate helps prevent the bladder neck opening at unwanted times and has been shown to help patients with overactive bladder syndrome pass urine less frequently than before treatment. It is postulated that this drug will also prove effective in elderly patients (aged > 65 years) and that the ability to change dose between 4 and 8mg will allow each patient to have an optimised treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12 |
8.80; 8.48; -2.48; -3.84 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 |
6.7; 5.3; 5.7; 4.3; 5.3; 3.7 | <0.0001 sig |
| SECONDARY Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 |
4.11; 3.53; -0.96; -1.81; -1.53; -2.12 | 0.0001 sig |
| SECONDARY Percent Change From Baseline of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12 |
-0.7; -1.3; -1.0; -1.7; -1.3; -2.0 | 0.0005 sig |
| SECONDARY Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 4, 8, and 12 |
12.10; 11.89; -0.69; -1.47; -1.11; -1.95 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Micturitions Per 24 Hours at Weeks 4, 8, and 12 |
-0.7; -1.3; -1.0; -1.7; -1.3; -2.0 | <0.0001 sig |
| SECONDARY Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12 |
2.92; 2.80; -0.22; -0.38; -0.30; -0.51 | 0.0026 sig |
| SECONDARY Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12 |
-0.3; -0.3; -0.3; -0.7; -0.3; -0.7 | 0.0012 sig |
| SECONDARY Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4, 8, and 12 |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | 0.1005 |
| SECONDARY Percent Change From Baseline of UUI Episodes Per 24 Hours at Weeks 4, 8, and 12 |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | 0.0218 sig |
| SECONDARY Change From Baseline in Daily Sum Rating in USS at Weeks 4, 8, and 12 |
37.55; 36.07; -4.35; -8.52; -6.53; -10.81 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Were Incontinent at Baseline and Became Dry |
45.0; 53.2 | 0.1113 |
| SECONDARY Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12 |
1.49; 1.35; -0.20; -0.27; -0.15; -0.38 | 0.0230 sig |
| SECONDARY Percentage of Participants With Improvement at Week 12 |
42.9; 67.7 | <0.0001 sig |
| SECONDARY Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 |
168; 192; 202; 168; 40; 16 | — |
| SECONDARY Change From Baseline in PPBC at Week 8 |
185; 210; 166; 119; 22; 13 | — |
| SECONDARY Change From Baseline in PPBC at Week 12 |
204; 256; 164; 104; 33; 17 | <0.0001 sig |
| SECONDARY Change From Baseline in PPBC at Week 24 |
— | — |
| SECONDARY Change From Baseline Patient Perception of Urgency Scale (PPUS) at Week 4 |
74; 90; 263; 250; 33; 21 | — |
| SECONDARY Change From Baseline in PPUS at Week 8 |
95; 111; 224; 194; 32; 25 | — |
| SECONDARY Change From Baseline in PPUS at Week 12 |
109; 133; 226; 200; 32; 28 | 0.0009 sig |
| SECONDARY Change From Baseline in PPUS at Week 24 |
— | — |
| SECONDARY Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Symptom/Bother Score at Weeks 4, 8, 12, and 24 |
52.90; 50.58; -9.03; -14.05; -12.86; -18.03 | <0.0001 sig |
| SECONDARY Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Total Score at Weeks 4, 8, 12, and 24 |
62.45; 64.42; 7.28; 10.24; 9.36; 12.96 | <0.0001 sig |
| SECONDARY Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24 |
57.52; 58.31; 8.35; 11.90; 10.46; 14.98 | 0.0002 sig |
| SECONDARY Change From Week 12 in Overactive Bladder Satisfaction (OAB-S) Scale for Satisfaction With OAB Control at Week 24 |
44.97; 63.01; 21.22; 3.58 | <0.001 sig |
| SECONDARY Change From Week 12 in OAB-S Scale for OAB Medication Expectation at Week 24 |
2.21; 2.85; 0.74; 0.17 | <0.0001 sig |
| SECONDARY Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 |
35.87; 25.00; -2.38; 2.59; 75.36; 73.96 | 0.3163 |
| SECONDARY Change From Baseline in EQ-5D- Health State Profile Utility Score at Week 12 |
0.7825; 0.8092; 0.0230; 0.0064 | 0.8959 |
| SECONDARY Change From Baseline in EQ-5D- Each Dimension Score at Week 12 |
— | — |
| SECONDARY Change From Baseline in Mini Mental State Examination (MMSE) at Week 12 |
28.09; 28.20; 0.23; 0.24 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female ≥65 years old.
- Overactive bladder symptoms for at least 3 months prior to study start.
- Eight or more micturitions per 24 hours as confirmed by diary records
Exclusion Criteria
- Predominant Stress Urinary Incontinence
- Active or recurrent bladder infections
- Other bladder and genital conditions that could be the predominant cause of symptoms or interfere with treatment assessment and success.
Data sourced from ClinicalTrials.gov (NCT00798434). 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.