A Double-Blind, Paralleled Study Comparing Efficacy/Safety of Solifenacin to Tolterodine in Overactive Bladder Patients

Astellas Pharma Inc246 enrolled

Overview

To evaluate the efficacy and safety of solifenacin succinate (Vesicare) 5mg OD in subjects with overactive bladder compared to tolterodine wmg, bid

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

246

Conditions

Urinary Bladder, Overactive

Interventions

solifenacin succinateDRUG

Oral

tolterodineDRUG

oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients willing and able to complete the micturition diary correctly * Patients experiencing frequency of micturition as verified in the diary * Patients experiencing significant post void residual volume * OAB symptoms including urinary frequency, urgency or urge incontinence for 3 months or more. Exclusion Criteria: * Significant post void residual volume * Patients with indwelling catheters or practicing intermittent self- catheterization * Known or suspected hypersensitivity to solifenacin succinate or other anticholinergics or lactose

Locations (4)

Unnamed facility

Beijing, China

Unnamed facility

Chongqing, China

Unnamed facility

Hangzhou, China

Unnamed facility

Shanghai, China

Outcomes

Primary Outcomes

Change from baseline in mean number of micturitions per 24 hours

Time frame: 8 Weeks

Secondary Outcomes

Change from baseline in mean volume voided per micturition

Time frame: 8 Weeks

Change from baseline in mean number of incontinence episodes per 24 hours

Time frame: 8 Weeks

Change from baseline in mean urgency frequency per 24 hours

Time frame: 8 Weeks

Change from baseline in mean nocturia episodes per 24 hours

Time frame: 8 Weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.