Phase 3
N=516
A Clinical Trial To Assess Fesoterodine On Treatment Satisfaction And Symptom Improvement In Overactive Bladder Patients
Overactive Bladder
Bottom Line
View on ClinicalTrials.gov: NCT00425100 ↗Enrolled (actual)
516
Serious AEs
—
Results posted
Feb 2009
Primary outcome: Primary: Mean Number of Micturition Episodes Per 24 Hours — 12.7; 9.7 number of episodes — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- fesoterodine fumarate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Number of Micturition Episodes Per 24 Hours |
12.7; 9.7 | <0.0001 sig |
| PRIMARY Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours |
2.3; 0.6 | <0.0001 sig |
| PRIMARY Mean Number of Urgency Episodes Per 24 Hours |
10.0; 5.0 | <0.0001 sig |
| PRIMARY Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment |
378; 42; 54 | — |
| SECONDARY Nocturnal Micturitions Per 24 Hours |
2.6; 1.8 | <0.0001 sig |
| SECONDARY Severe Urgency Episodes Per 24 Hours |
5.0; 1.5 | <0.0001 sig |
| SECONDARY Mean Rating on the Urinary Sensation Scale |
3.2; 2.5 | <0.0001 sig |
| SECONDARY Patient Perception of Bladder Condition (PPBC) Score |
4.9; 3.1 | <0.0001 sig |
| SECONDARY Patient Perception of Bladder Condition (PPBC) Score at Week 12 Relative to Baseline (Categorical Change) |
405; 72; 10 | — |
| SECONDARY Urgency Perception Scale (UPS) |
0.8; 1.4 | <0.0001 sig |
| SECONDARY Urgency Perception Scale (UPS) at Week 12 Relative to Baseline (Categorical Change) |
237; 248 | — |
| SECONDARY Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Concern Domain |
50.5; 79.1 | <0.0001 sig |
| SECONDARY Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Coping Domain |
44.7; 75.3 | <0.0001 sig |
| SECONDARY Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Sleep Domain |
47.4; 72.3 | <0.0001 sig |
| SECONDARY Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Social Interaction Domain |
71.3; 88.1 | <0.0001 sig |
| SECONDARY Overactive Bladder Questionnaire (OAB-q) - Total Health Related Quality of Life (HRQL) Scale |
52.2; 78.3 | <0.0001 sig |
| SECONDARY Overactive Bladder Questionnaire (OAB-q) - Symptom Bother Scale |
57.4; 28.6 | <0.0001 sig |
| SECONDARY "Satisfaction With OAB Control" Module of Overactive Bladder (OAB) Treatment Satisfaction Questionnaire (TSQ) (OAB-S) |
74.7; 82.7; 43.6 | — |
| SECONDARY Sum Rating on the Urinary Sensation Scale |
40.4; 25.2 | <0.0001 sig |
| SECONDARY Treated Subjects Reporting Satisfaction With Their Current OAB Treatment (Supportive Analysis) |
378; 42; 54; 42 | — |
Summary
To evaluate the effect of fesoterodine on patient satisfaction and overactive bladder (OAB) symptom relief in OAB patients who were dissatisfied with their prior therapy with tolterodine.
Eligibility Criteria
Inclusion Criteria
- OAB patients who present with OAB symptoms(≥8 micturitions and ≥3 urgency episodes per 24 h documented in the baseline bladder diary)
- OAB patients dissatisfied with their prior therapy with tolterodine
Exclusion Criteria
- Patients with any contraindication to fesoterodine usage, e.g., urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, or known hypersensitivity to the drug or its ingredients.
- Patients with significant hepatic and renal disease or other significant unstable diseases.
- OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
Data sourced from ClinicalTrials.gov (NCT00425100). 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.