A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency

Study Overview
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Brief Summary
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This study is designed to assess the efficacy of a flexible dose regimen of fesoterodine on micturition related nocturnal urgency episodes.

Official Title
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A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Trial To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency.

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: Fesoterodine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mean urinary frequency of >=8 micturitions per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in visit (Visit 2) Mean number of micturition related urgency episodes >=3 per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in /Visit 2 (Urgency episodes are defined as those with Urinary Sensation Scale rating >=3) Mean number of micturition related nocturnal urgency episodes >=2 but no more than 8 episodes per 24 hours as verified by the bladder diary at Visit 2 (nocturnal urgency episodes are defined as those with Urinary Sensation Scale rating of >3 recorded in the bed time section of the bladder diary) Exclusion Criteria: A known recent history or previous diagnosis of any sleep disorder such as obstructive sleep apnea, primary insomnia, periodic limb movement, parasomnia Nocturia due to other underlying uncontrolled conditions, such as congestive heart failure, diabetes mellitus, diabetes insipidus, polyuria of any cause, etc.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fesoterodine<br> | Drug: Fesoterodine<br>* Fesoterodine 4mg and 8 mg tablets taken daily.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo sham 4mg and 8 mg tables taken daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours | Micturition-related nocturnal urgency episodes had urinary sensation scale (USS) rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit. | Baseline | 
| Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 12 | Micturition-related nocturnal urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit. | Baseline and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 | Micturition-related nocturnal urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of micturition-related nocturnal urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit. | Baseline and Week 4 | 
| Percent Change From Baseline in Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 and 12 | Percent change of micturition-related nocturnal urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline). | Baseline, Week 4 and 12 | 
| Number of Nocturnal Micturitions Per 24 Hours | Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit. | Baseline | 
| Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 4 and 12 | Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit. | Baseline, Week 4 and 12 | 
| Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12 | Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline). | Baseline, Week 4 and 12 | 
| Mean Number of Micturitions Per 24 Hours | Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence [UUI]. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine. | Baseline | 
| Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12 | Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine. | Baseline, Week 4 and 12 | 
| Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12 | Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline). | Baseline, Week 4 and 12 | 
| Number of Micturition-related Urgency Episodes Per 24 Hours | The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. | Baseline | 
| Change From Baseline in Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12 | The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. | Baseline, Week 4 and 12 | 
| Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12 | Percent change of micturition-related urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline). | Baseline, Week 4 and 12 | 
| Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours | UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. | Baseline | 
| Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12 | UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. | Baseline, Week 4 and 12 | 
| Percent Change From Baseline in of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12 | Percent change of UUI episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline). | Baseline, Week 4 and 12 | 
| Nocturnal Frequency-urgency Sum Rating Per 24 Hours | Frequency-urgency sum is total USS ratings recorded for all nocturnal micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement. | Baseline | 
| Change From Baseline in Nocturnal Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12 | Frequency-urgency sum is total USS ratings recorded for all nocturnal micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement. | Baseline, Week 4 and 12 | 
| Frequency-urgency Sum Rating Per 24 Hours | Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. | Baseline | 
| Change From Baseline in Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12 | Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement. | Baseline, Week 4 and 12 | 
| Mean Voided Volume Per Nocturnal Micturition | Mean voided volume per nocturnal micturition was calculated as sum of voided volume during bedtime divided by the total number of bedtime micturition episodes with a recorded voided volume greater than 0 at that visit. | Baseline | 
| Change From Baseline in Mean Voided Volume Per Nocturnal Micturition at Week 12 | Mean voided volume per nocturnal micturition was calculated as sum of voided volume during bedtime divided by the total number of bedtime micturition episodes with a recorded voided volume greater than 0 at that visit. | Baseline and Week 12 | 
| Mean Voided Volume Per Micturition | Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of total micturition episodes with a recorded voided volume greater than 0 at that visit. | Baseline | 
| Change From Baseline in Mean Voided Volume Per Micturition at Week 12 | Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of total micturition episodes with a recorded voided volume greater than 0 at that visit. | Baseline and Week 12 | 
| Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score | OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother. | Baseline | 
| Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12 | OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother. | Baseline, Week 4 and 12 | 
| Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) | OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL. | Baseline | 
| Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12 | OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL. | Baseline, Week 4 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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incontinence OAB urgency nocturia