Phase 3
Completed N=2,446
Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine for Overactive Bladder (OAB)
Source: ClinicalTrials.gov NCT00444925 ↗Enrolled (actual)
2,446
Serious AEs
—
Results posted
Sep 2009
Primary outcomePrimary: Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (End of Treatment). — -1.46; -1.61; -1.72 number of 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 (End of Treatment). |
-1.46; -1.61; -1.72 | <0.0001 sig |
| SECONDARY Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 1 and Week 4. |
-0.54; -0.92; -0.95; -1.06; -1.40; -1.52 | <0.0001 sig |
| SECONDARY Percent Change From Baseline of UUI Episodes Per 24 Hours. |
-28.6; -55.1; -53.6; -60.0; -85.7; -93.2 | <0.0001 sig |
| SECONDARY Change From Baseline in Mean Voided Volume Per Micturition. |
11.0; 19.2; 18.7; 14.0; 25.7; 30.5 | 0.0214 sig |
| SECONDARY Change From Baseline in Mean Number of Micturitions Per 24 Hours. |
-0.5; -1.0; -1.0; -1.2; -1.8; -1.9 | 0.0002 sig |
| SECONDARY Percent Change From Baseline of Micturitions Per 24 Hours. |
-2.7; -7.7; -7.9; -10.3; -15.0; -14.8 | 0.0001 sig |
| SECONDARY Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours. |
-0.1; -0.3; -0.2; -0.4; -0.5; -0.5 | 0.2730 |
| SECONDARY Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours. |
-10.0; -12.5; 0.0; -22.2; -25.0; -20.0 | — |
| SECONDARY Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours. |
-0.4; -1.3; -1.1; -1.2; -2.4; -2.6 | 0.0008 sig |
| SECONDARY Percent Change From Baseline of Urgency Episodes Per 24 Hours. |
-5.6; -12.5; -9.7; -11.4; -23.1; -26.9 | 0.0004 sig |
| SECONDARY Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours. |
-0.4; -1.3; -1.2; -1.2; -2.2; -2.4 | <0.0001 sig |
| SECONDARY Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours. |
-9.4; -25.0; -25.0; -25.0; -45.8; -54.5 | <0.0001 sig |
| SECONDARY Change From Baseline in Mean USS Rating Per Micturition Per 24 Hours. |
-0.1; -0.2; -0.2; -0.2; -0.4; -0.5 | <0.0001 sig |
| SECONDARY Change From Baseline in Frequency-Urgency Sum (Formerly Known as Urinary Sensations Scale Sum in Protocol) Per 24 Hours. |
-2.4; -5.7; -5.5; -5.7; -9.7; -10.5 | <0.0001 sig |
| SECONDARY Change From Baseline in Patient Perception of Bladder Condition (PPBC). |
32; 79; 102; 94; 181; 186 | 0.0143 sig |
| SECONDARY Change From Baseline in Urgency Perception Scale (UPS). UPS Equals Patient Perception of Urgency Scale (PPUS) in Protocol. |
68; 162; 171; 218; 438; 413 | 0.0773 |
| SECONDARY Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12 (End of Treatment). |
-16.3; -22.5; -27.1 | <0.0001 sig |
| SECONDARY Change From Baseline in OAB-q: Health Related Quality of Life (HRQL) at Week 12 (End of Treatment). |
13.4; 19.3; 22.6; 14.0; 18.5; 22.6 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Adult overactive bladder (OAB) patients who present with OAB symptoms, including urinary frequency >= 8 per day and urgency urinary incontinence >=1 per day
Exclusion Criteria
- Patients with conditions that would contraindicate for fesoterodine use, e.g, hypersensitivity to the active substance (fesoterodine) or to peanut or soya or any of the excipients, urinary retention, and gastric retention.
- 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 (NCT00444925). 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.