Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder.

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of fesoterodine in comparison to placebo for overactive bladder.

Official Title
-----------------
A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo In Patients With Overactive Bladder.

Conditions
-----------------
Overactive Bladder

Intervention / Treatment
-----------------
* Drug: fesoterodine fumarate
* Drug: Placebo
* Drug: fesoterodine fumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult OAB patients who present with OAB symptoms, including micturitions >= 8 per day and urgency urinary incontinence >= 1 per day. Exclusion Criteria: Patient has known hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients. Patient has a known neurological disease influencing bladder function. Patient has a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction or pelvic organ prolapse.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fesoterodine fumarate 4 mg (Double-Blind)<br> | Drug: fesoterodine fumarate<br>* 4mg tablets OD for 12 weeks<br>|
| Placebo Comparator: Placebo (Double-Blind)<br> | Drug: Placebo<br>* Corresponding placebo tablets OD for 12 weeks<br>|
| Experimental: Fesoterodine fumarate 8 mg (Double-Blind)<br> | Drug: fesoterodine fumarate<br>* 8mg tablets OD for 12 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12. | Number of urgency urinary incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at Week 12 minus mean at Baseline. | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Number of urgency urinary incontinence (UUI) episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at each visit minus mean at Baseline. | Baseline to Weeks 2, 4, 8, and 12 | 
| Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12. | Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at Week 12 minus mean at Baseline. | Baseline to Week 12 | 
| Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. | Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at each visit minus mean at Baseline. | Baseline to Weeks 2, 4, 8, and 12 | 
| Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12. | Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at Week 12 minus mean at Baseline. | Baseline to Week 12 | 
| Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at each visit minus mean at Baseline. | Baseline to Weeks 2, 4, 8, and 12 | 
| Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12. | Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Incontinence is the complaint of any involuntary leakage of urine. Change: mean at Week 12 minus mean at Baseline. | Baseline to Week 12 | 
| Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Incontinence is the complaint of any involuntary leakage of urine. Change: mean at each visit minus mean at Baseline. | Baseline to Weeks 2, 4, 8, and 12 | 
| Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Week 12. | Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at Week 12 minus mean at Baseline. | Baseline to Week 12 | 
| Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. | Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at each visit minus mean at Baseline. | Baseline to Weeks 2, 4, 8, and 12 | 
| Change From Baseline in Mean Voided Volume Per Micturition at Week 12. | Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Voided volume was recorded during any 1 day of 3-day diary period through the first micturition of the next day. Change: mean at Week 12 minus mean at Baseline. | Baseline to Week 12 | 
| Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12. | Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at each visit minus mean at Baseline. | Baseline to Weeks 2, 4, 8, and 12 | 
| Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). | King's Health Questionnaire(KHQ) is used to assess the impact of bladder problems on quality of life. The each domain score was calculated valued and ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response. Change: mean at Week 12 minus mean at Baseline. | Baseline to Week12 | 
| Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12. | The overactive bladder questionnaire (OAB-q) is used to assess the extent of participants who had been bothered by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL). The each domain score ranges from 0 to 100 is a calculated value, where 0=minimal symptom severity and 100=greatest symptom severity for Symptom Bother Score, and where 0=worst HRQL outcome/response and 100=best HRQL outcome/response for HRQL domains including total score of HROL domain. Change: mean at Week 12 minus mean at Baseline. | Baseline to Week 12 | 
| Change From Baseline for Patient Perception of Bladder Condition (PPBC) at Week 12. | Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows: No problems at all Some very minor problems Some minor problems Some moderate problems Severe problems Many severe problems Change: mean at Week 12 minus mean at Baseline. | Baseline to Week 12 | 
| The Number of Patients With Severe Problems, Score 5 or Many Severe Problems, Score 6 in Patient Perception of Bladder Condition (PPBC) at Week 12. | Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows: No problems at all Some very minor problems Some minor problems Some moderate problems Severe problems Many severe problems | Baseline to Week 12 |