Tolterodine is approved for use in the treatment of overactive bladder (OAB). The study is designed to a investigate whether pregabalin may have efficacy in OAB and whether the efficacy is altered when it is combined with tolterodine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
188
Tolterodine SR Oral, 2mg, once daily for 4 weeks Pregabalin, Oral, 75 mg, twice daily for 4 weeks
Tolterodine SR, Oral, 4 mg, once daily for 4 weeks
Placebo, Oral, twice daily for 4 weeks
Pfizer Investigational Site
Hradec Králové, Czechia
Pfizer Investigational Site
Change in mean voided volume per micturition (from baseline).
Time frame: 4 weeks
Percentage and absolute change in incontinence episode frequency after 4 weeks of treatment (for subjects with incontinence at baseline).
Time frame: 4 Weeks
Percentage and absolute change in urgency episode frequency
Time frame: 4 Weeks
Mean severity of urgency episodes
Time frame: 4 Weeks
Percentage and absolute change in micturition frequency
Time frame: 4 Weeks
Percentage and absolute change in normalized micturition frequency (NMF)
Time frame: 4 Weeks
Patient perception of their urinary urgency (using the OAB-q symptom severity scale)
Time frame: 4 Weeks
Patient perception of Health Related Quality of Life (using the OAB-q SF HRQL scale)
Time frame: 4 Weeks
Patient Perception of Bladder Condition (PPBC) scale
Time frame: 4 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tolterodine SR Oral, 4mg, once daily for 4 weeks Pregabalin, Oral, 150 mg, twice daily for 4 weeks
Pregabalin, Oral, 150 mg twice daily for 4 weeks
Prague, Czechia
Pfizer Investigational Site
Prague, Czechia
Pfizer Investigational Site
Praha 4 - Krc, Czechia
Pfizer Investigational Site
Ústí nad Labem, Czechia
Pfizer Investigational Site
Kaunas, Lithuania
Pfizer Investigational Site
Kaunas, Lithuania
Pfizer Investigational Site
Vilnius, Lithuania
Pfizer Investigational Site
Vilnius, Lithuania
Pfizer Investigational Site
Haugesund, Norway
...and 13 more locations