A Study to Evaluate the Efficacy of Tolterodine on Specific Symptoms in Adult Patients With Overactive Bladder.

Phase 4

Completed

• Conditions: Urinary Bladder, Overactive
• Interventions: Drug: tolterodine extended release

• Registration Number: NCT00645281
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of tolterodine in impacting the primary symptom or complaint of patients with OAB.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Study Completion: 2005-01
• Study First Submitted: 2008-03-25
• Study First Submitted QC: 2008-03-25
• Study First Posted: 2008-03-27
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 896

Inclusion Criteria

• self-reported symptoms of OAB for ≥ 3 months prior to screening
• OAB as defined by urinary frequency (a minimum of 8 micturitions per 24 hours)
• urgency (defined as a strong and sudden desire to urinate) or urge incontinence a minimum of 2 episodes in 3 days, as confirmed by the micturition diary between screening and baseline
• patients who describe the degree of bothersomeness of their most bothersome OAB symptom as "moderately ", "a great deal ", or "a very great deal" per the OAB Bother Rating Scale

Exclusion Criteria

• any condition that would contraindicate their usage of tolterodine once daily, including: narrow angle glaucoma, urinary retention, gastric retention
• any clinically significant local urinary tract pathology which could mimic the symptoms of OAB, such as infection or hematuria
• stress incontinence, functional, or overflow incontinence as determined by the investigator
• symptomatic acute urinary tract infection (UTI) during the run-in period, or recurrent UTIs defined by treatment for symptomatic UTI >3 times in the 12 months prior to participation in this clinical trial
• clinically significant urinary tract obstruction
• history of lower urinary tract surgery (e.g. prostate removal or destruction, incontinence surgery) within the past 3 months
• clinically significant interstitial cystitis or significant bladder pain syndrome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
tolterodine ER group	tolterodine extended release	-

Primary Outcome Measures

Name	Time	Method
Change from baseline to Week 12 in the micturition bladder diary variable related to the primary symptom of the patient at the time of study entry	12 weeks

Secondary Outcome Measures

Name	Time	Method
To asses the safety of tolterodine in patients with OAB	12 weeks
Change from baseline to Week 4 and 12 in micturition bladder diary variables	12 weeks
Change from baseline to Week 4 and 12 in OAB questionnaire	12 weeks
Overall Treatment Effect Scale of Overactive Bladder Control at Week 4 and 12	12 weeks
OAB Bother Rating Scale at baseline	baseline
Change from baseline to Week 4 and 12 in Patient's Perception of Bladder Condition	12 weeks
Change from baseline to Week 4 and 12 in AUA Symptom Index	12 weeks
Clinical Global Impression-Improvement at Week 12	12 weeks

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Wauwatosa, Wisconsin, United States