A Clinical Trial To Assess Fesoterodine On Treatment Satisfaction And Symptom Improvement In Overactive Bladder Patients

Phase 3 Completed 516 enrolled Pfizer

Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2007-01
Primary completion: 2007-10
Completion: 2007-10

Outcome

Met primary endpoint

registry analysis (superiority or other test); Open Label Baseline vs Open Label Week 12; p <0.0001; Mean Difference (Net) -3.0 (95% CI -3.2 to -2.7); 2-sided paired t-test; NCT00425100 ↗

registry analysis (superiority or other test); Open Label Baseline vs Open Label Week 12; p <0.0001; Mean Difference (Net) -1.7 (95% CI -2.0 to -1.4); 2-sided paired t-test; NCT00425100 ↗

registry analysis (superiority or other test); Open Label Baseline vs Open Label Week 12; p <0.0001; Mean Difference (Net) -5.0 (95% CI -5.4 to -4.5); 2-sided paired t-test; NCT00425100 ↗

Publications

Wyndaele JJ, Goldfischer ER, Morrow JD, Gong J, Tseng LJ, Guan Z, Choo MS. Effects of flexible-dose fesoterodine on overactive bladder symptoms and treatment satisfaction: an open-label study. Int J Clin Pract. 2009 Apr;63(4):560-7. doi: 10.1111/j.1742-1241.2009.02035.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fesoterodine	Other / unclassified	4 mg	—
Subject	Fesoterodine	Other / unclassified	8 mg	—