Phase 4
Completed N=1,955
A 12 Week Study to Confirm the Effectiveness of 8mg of Fesoterodine Compared to 4mg of Fesoterodine
Source: ClinicalTrials.gov NCT01302067 ↗Enrolled (actual)
1,955
Serious AEs
1.6%
Results posted
Dec 2013
Primary outcomePrimary: Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12. — -2.85; -2.22; -3.12 Episodes per 24 hours — p=<0.0001
Summary
This study is designed to confirm if 8mg of fesoterodine is more effective in reducing overactive bladder symptoms than 4mg of fesoterodine. In addition the study is designed to assess if the higher dose reduces the overall effect of overactive bladder on the subject's daily life more than the lower dose. The study also assesses the side effects and safety of the two doses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12. |
-2.85; -2.22; -3.12 | <0.0001 sig |
| SECONDARY Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4. |
-1.95; -1.19; -2.33 | <0.0001 sig |
| SECONDARY Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12. |
-2.45; -1.58; -2.97 | <0.0001 sig |
| SECONDARY Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 4. |
-14.58; -9.01; -17.24 | <0.0001 sig |
| SECONDARY Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 12. |
-19.74; -12.16; -24.14 | <0.0001 sig |
| SECONDARY Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 4. |
-2.55; -1.99; -2.75 | <0.0001 sig |
| SECONDARY Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 4. |
-77.78; -60.50; -82.48 | <0.0001 sig |
| SECONDARY Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 12. |
-93.75; -78.89; -100.00 | <0.0001 sig |
| SECONDARY Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 4. |
-2.89; -1.85; -3.40 | <0.0001 sig |
| SECONDARY Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12. |
-4.23; -2.99; -5.01 | <0.0001 sig |
| SECONDARY Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 4. |
-23.26; -14.70; -27.27 | <0.0001 sig |
| SECONDARY Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 12. |
-34.88; -22.73; -44.29 | <0.0001 sig |
| SECONDARY Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12. |
38; 25; 27; 172; 122; 151 | <0.0001 sig |
| SECONDARY Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12. |
37; 23; 30; 361; 193; 305 | 0.0007 sig |
| SECONDARY Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12. |
-30.19; -22.41; -34.88 | <0.0001 sig |
| SECONDARY Change From Baseline in Health Related Quality of Life (HRQL)-Coping Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. |
26.69; 20.91; 31.38 | <0.0001 sig |
| SECONDARY Change From Baseline in Health Related Quality of Life (HRQL)-Concern Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. |
26.82; 20.27; 31.18 | <0.0001 sig |
| SECONDARY Change From Baseline in Health Related Quality of Life (HRQL)-Sleep Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. |
21.97; 18.25; 25.71 | <0.0001 sig |
| SECONDARY Change From Baseline in Health Related Quality of Life (HRQL)-Social Interaction Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. |
16.43; 12.61; 20.11 | <0.0001 sig |
| SECONDARY Change From Baseline in Health Related Quality of Life (HRQL)-Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. |
23.70; 18.57; 27.94 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Became Dry at Week 4. |
35.5; 26.4; 36.2 | 0.0016 sig |
| SECONDARY Percentage of Participants Who Became Dry at Week 12. |
49.2; 39.5; 57.8 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- 6 months overactive bladder symptoms, minimum of 2 urgency urinary incontinence episodes per 24 hours and minimum of 8 micturitions per 24 hours.
Exclusion Criteria
- Other concurrent and concomitant medication or disease that could put the subjects at additional risk or interfere with the study results.
Data sourced from ClinicalTrials.gov (NCT01302067). 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.