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

Study Overview
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Brief Summary
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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.

Official Title
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Symptom Specific Effectiveness of Tolterodine ER 4 mg in Patients With Symptoms of Overactive Bladder (OAB) in a Primary Care Setting. A Phase IV, Open-label, Single-arm, Non-randomized, Trial in Adult Patients With OAB.

Conditions
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Urinary Bladder, Overactive

Intervention / Treatment
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* Drug: tolterodine extended release


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tolterodine ER group<br> | Drug: tolterodine extended release<br>* Tolterodine ER capsule 4 mg daily for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OAB Bother Rating Scale at baseline |  | baseline | 
| Change from baseline to Week 4 and 12 in micturition bladder diary variables |  | 12 weeks | 
| 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 | 
| Change from baseline to Week 4 and 12 in OAB questionnaire |  | 12 weeks | 
| Clinical Global Impression-Improvement at Week 12 |  | 12 weeks | 
| Overall Treatment Effect Scale of Overactive Bladder Control at Week 4 and 12 |  | 12 weeks | 
| To asses the safety of tolterodine in patients with OAB |  | 12 weeks |