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

Phase 4

Completed

Conditions: Overactive Bladder

Interventions: Drug: Placebo
Drug: Fesoterodine

Registration Number: NCT00911937

Lead Sponsor: Pfizer

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 963

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Fesoterodine	Fesoterodine	-

Primary Outcome Measures

Name	Time	Method
Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours	Baseline	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.
Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 12	Baseline and 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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Voided Volume Per Micturition at Week 12	Baseline and 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.
Change From Baseline in Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12	Baseline, 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.
Mean Voided Volume Per Nocturnal Micturition	Baseline	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.
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)	Baseline	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.
Percent Change From Baseline in Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 and 12	Baseline, 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).
Number of Nocturnal Micturitions Per 24 Hours	Baseline	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.
Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours	Baseline	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.
Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12	Baseline, 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.
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12	Baseline, 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.
Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12	Baseline, 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).
Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score	Baseline	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.
Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4	Baseline and 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.
Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12	Baseline, 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).
Percent Change From Baseline in of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12	Baseline, 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).
Change From Baseline in Mean Voided Volume Per Nocturnal Micturition at Week 12	Baseline and 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.
Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 4 and 12	Baseline, 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.
Mean Number of Micturitions Per 24 Hours	Baseline	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.
Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12	Baseline, 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).
Number of Micturition-related Urgency Episodes Per 24 Hours	Baseline	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.
Change From Baseline in Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12	Baseline, 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.
Nocturnal Frequency-urgency Sum Rating Per 24 Hours	Baseline	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.
Change From Baseline in Nocturnal Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12	Baseline, 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.
Frequency-urgency Sum Rating Per 24 Hours	Baseline	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.
Mean Voided Volume Per Micturition	Baseline	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.
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12	Baseline, 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.
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	Baseline, 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.