Phase 3
Completed N=2,417
Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder.
Source: ClinicalTrials.gov NCT00611026 ↗Enrolled (actual)
2,417
Serious AEs
1.1%
Results posted
Jan 2011
Primary outcomePrimary: Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 — -1.62; -1.74; -1.95 episodes per 24 hours — p=<0.0001
Summary
To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder
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 |
-1.62; -1.74; -1.95 | <0.0001 sig |
| SECONDARY Change From Baseline in Mean Voided Volume Per Micturition |
9.80; 15.65; 18.63; 14.27; 26.43; 32.26 | 0.0020 sig |
| SECONDARY Change From Baseline in Mean Number of Micturitions Per 24 Hours |
-0.8; -1.0; -1.0; -1.5; -1.8; -2.1 | 0.0161 sig |
| SECONDARY Percent Change From Baseline of Micturitions Per 24 Hours |
-7.1; -9.4; -9.0; -13.4; -16.7; -18.9 | 0.0217 sig |
| SECONDARY Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours |
-0.2; -0.3; -0.3; -0.4; -0.5; -0.5 | 0.3823 |
| SECONDARY Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours |
-7.7; -14.3; -12.5; -20.0; -25.0; -25.0 | 0.0021 sig |
| SECONDARY Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1 and Week 4 |
-0.80; -0.95; -1.03; -1.31; -1.52; -1.68 | 0.0006 sig |
| SECONDARY Percent Change From Baseline of UUI Episodes Per 24 Hours |
-40.8; -50.0; -50.0; -75.0; -88.9; -100.0 | 0.0012 sig |
| SECONDARY Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary) |
-0.8; -1.0; -1.2; -1.9; -2.5; -3.1 | 0.0374 sig |
| SECONDARY Percent Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary) |
-9.4; -12.0; -11.8; -17.2; -26.3; -32.1 | 0.0828 |
| SECONDARY Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours |
-1.14; -1.34; -1.58; -2.14; -2.71; -3.21 | 0.0576 |
| SECONDARY Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours |
-19.7; -24.1; -25.0; -41.7; -55.6; -61.1 | <0.0001 sig |
| SECONDARY Change From Baseline in Mean Urinary Sensation Scale (USS) Rating Per Micturition Per 24 Hours. |
-0.2; -0.2; -0.2; -0.3; -0.4; -0.5 | 0.0701 |
| SECONDARY Change From Baseline in Frequency-Urgency Sum (FUS) Per 24 Hours (Synonymous With USS Sum in the Study Protocol) |
-4.0; -4.8; -5.5; -8.1; -10.1; -12.0 | 0.0136 sig |
| SECONDARY Diary Dry Rate: Percentage of Participants With no Urgency Urinary Incontinence (UUI) in the 3-day Bladder Diary |
17.6; 24.5; 25.1; 39.5; 46.7; 51.1 | 0.0008 sig |
| SECONDARY Change From Baseline in Patient Perception of Bladder Condition (PPBC) |
43; 138; 144; 144; 278; 280 | 0.0009 sig |
| SECONDARY Change From Baseline in Urgency Perception Scale (UPS). UPS Formerly Known as Patient Perception of Urgency Scale (PPUS) in the Protocol. |
97; 264; 267; 326; 619; 609 | 0.0011 sig |
| SECONDARY Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12 |
-21.8; -24.3; -28.9 | <0.0001 sig |
| SECONDARY Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Health Related Quality of Life (HRQL) at Week 12 |
17.2; 19.5; 22.9; 20.2; 22.5; 26.8 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Adult subjects with overactive bladder symptoms (subject-reported) for greater than or equal to 3 months prior to Screening/Enrollment visit.
- Reported at least an average of 1 UUI episode per 24 hours in the 3-day bladder diary prior to the Randomization/Baseline visit
- Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours as verified by the 3-day bladder diary prior to randomization/Baseline visit.
Exclusion Criteria
- Subjects with any condition that would contraindicate their usage of fesoterodine including: hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, and toxic megacolon.
- Subjects with clinically significant hepatic or renal disease or other significant unstable diseases.
- OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
- Subjects with previous history of acute urinary retention requiring catheterization, or severe voiding difficulties in the judgment of the investigator, prior to baseline.
Data sourced from ClinicalTrials.gov (NCT00611026). 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.