Trial Outcomes & Findings for UK Study Assessing Flexible Dose Fesoterodine in Adults (NCT NCT00806494)
NCT ID: NCT00806494
Last Updated: 2011-01-26
Results Overview
The number of micturitions was measured by the 3-day bladder diary completed for the 3 consecutive days preceding each clinic visit. The mean number of micturitions per 24 hours was calculated as the sum of all micturitions recorded in the diary divided by the number of days the diary was completed at that visit. Change=mean at observation minus mean at baseline. Negative change, more specifically (ie), a decrease in number of micturitions relative to baseline=improvement.
COMPLETED
PHASE4
331 participants
Baseline, Week 12
2011-01-26
Participant Flow
Participant milestones
| Measure |
Fesoterodine
Fesoterodine 4mg tablet orally once daily (QD) for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
|
|---|---|
|
Overall Study
STARTED
|
331
|
|
Overall Study
COMPLETED
|
251
|
|
Overall Study
NOT COMPLETED
|
80
|
Reasons for withdrawal
| Measure |
Fesoterodine
Fesoterodine 4mg tablet orally once daily (QD) for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
|
|---|---|
|
Overall Study
Adverse Event
|
29
|
|
Overall Study
Lack of Efficacy
|
6
|
|
Overall Study
Lost to Follow-up
|
10
|
|
Overall Study
Other
|
30
|
|
Overall Study
Withdrawal by Subject
|
5
|
Baseline Characteristics
UK Study Assessing Flexible Dose Fesoterodine in Adults
Baseline characteristics by cohort
| Measure |
Fesoterodine
n=331 Participants
Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
|
|---|---|
|
Age, Customized
Between 18 to 44 Years
|
37 Participants
n=5 Participants
|
|
Age, Customized
Between 45 to 64 Years
|
163 Participants
n=5 Participants
|
|
Age, Customized
>= 65 Years
|
131 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
263 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Full analysis set (FAS)=participants who took at least one dose of study drug and provided baseline and post-baseline data for at least 1 efficacy endpoint. N=number of participants with analyzable data. Missing data at Week 12 were imputed using last (valid post-baseline) observation carried forward (LOCF) approach.
The number of micturitions was measured by the 3-day bladder diary completed for the 3 consecutive days preceding each clinic visit. The mean number of micturitions per 24 hours was calculated as the sum of all micturitions recorded in the diary divided by the number of days the diary was completed at that visit. Change=mean at observation minus mean at baseline. Negative change, more specifically (ie), a decrease in number of micturitions relative to baseline=improvement.
Outcome measures
| Measure |
Fesoterodine
n=317 Participants
Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
|
|---|---|
|
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12
|
-3.26 Number of Episodes
Interval -3.62 to -2.91
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: FAS. N=number of participants with analyzable data.
The number of micturitions was measured by the 3-day bladder diary completed for the 3 consecutive days preceding each clinic visit. The mean number of micturitions per 24 hours was calculated as the sum of all micturitions recorded in the diary divided by the number of days the diary was completed at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of micturitions relative to baseline=improvement.
Outcome measures
| Measure |
Fesoterodine
n=305 Participants
Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
|
|---|---|
|
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4
|
-2.55 Number of Episodes
Interval -2.87 to -2.23
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: FAS. n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.
Percentage change from baseline in micturitions was calculated as change in mean number of micturitions per 24 hours at that visit divided by the baseline mean number of micturitions per 24 hours, multiplied by 100.
Outcome measures
| Measure |
Fesoterodine
n=330 Participants
Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
|
|---|---|
|
Percentage Change From Baseline in the Number of Micturitions Per 24 Hours at Weeks 4 and 12
Week 4 (n=305)
|
-18.69 Percentage Change
Interval -20.86 to -16.51
|
|
Percentage Change From Baseline in the Number of Micturitions Per 24 Hours at Weeks 4 and 12
Week 12 (n=317)
|
-23.61 Percentage Change
Interval -25.86 to -21.36
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: FAS; participants reporting this symptom at baseline (participants with nocturnal \>0 micturitions per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.
Nocturnal micturitions were defined as those occurring between the time the subject went to bed and the time he or she arose to start the next day. 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. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of nocturnal micturitions relative to baseline=improvement.
Outcome measures
| Measure |
Fesoterodine
n=321 Participants
Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
|
|---|---|
|
Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12
Week 4 (n=297)
|
-0.61 Number of episodes
Interval -0.74 to -0.48
|
|
Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12
Week 12 (n=309)
|
-0.78 Number of episodes
Interval -0.91 to -0.64
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: FAS; participants reporting this symptom at baseline (participants with nocturnal \>0 micturitions per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.
Percentage change from baseline in nocturnal micturitions was calculated as change in mean number of nocturnal micturitions per 24 hours at that visit divided by the baseline mean number of nocturnal micturitions per 24 hours, multiplied by 100.
Outcome measures
| Measure |
Fesoterodine
n=321 Participants
Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
|
|---|---|
|
Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12
Week 4 (n=297)
|
-15.18 Percentage Change
Interval -21.24 to -9.13
|
|
Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12
Week 12 (n=309)
|
-23.35 Percentage Change
Interval -29.72 to -16.98
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: FAS; participants reporting this symptom at baseline (number of participants with UUI episodes \>0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.
UUI episodes were defined as those with a Urinary Sensation Scale (USS) rating of 5 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Mean number of UUI episodes per 24 hours was calculated as total number of micturitions with USS rating of 5 divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of UUI episodes relative to baseline=improvement.
Outcome measures
| Measure |
Fesoterodine
n=132 Participants
Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
|
|---|---|
|
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4 and 12
Week 4 (n=125)
|
-1.19 Number of Episodes
Interval -1.52 to -0.86
|
|
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4 and 12
Week 12 (n=127)
|
-1.64 Number of Episodes
Interval -2.02 to -1.25
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: FAS; participants reporting this symptom at baseline (number of participants with UUI episodes \>0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.
Percentage change from baseline in UUI episodes was calculated as change in mean number of UUI episodes per 24 hours at that visit divided by the baseline mean number of episodes per 24 hours, multiplied by 100.
Outcome measures
| Measure |
Fesoterodine
n=132 Participants
Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
|
|---|---|
|
Percentage Change From Baseline in UUI Episodes Per 24 Hours at Weeks 4 and 12
Week 4 (n=125)
|
-59.11 Percentage Change
Interval -70.61 to -47.6
|
|
Percentage Change From Baseline in UUI Episodes Per 24 Hours at Weeks 4 and 12
Week 12 (n=127)
|
-79.30 Percentage Change
Interval -88.51 to -70.1
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: FAS; participants reporting this symptom at baseline (number of participants with urgency episodes \>=3 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.
Urgency episodes were defined as those with a USS rating of \>=3 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Mean number of urgency episodes per 24 hours was calculated as total number of urgency episodes divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of urgency episodes relative to baseline=improvement.
Outcome measures
| Measure |
Fesoterodine
n=330 Participants
Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
|
|---|---|
|
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 4 and 12
Week 4 (n=303)
|
-3.94 Number of Episodes
Interval -4.43 to -3.44
|
|
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 4 and 12
Week 12 (n=317)
|
-5.10 Number of Episodes
Interval -5.62 to -4.58
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: FAS; participants reporting this symptom at baseline (participants with urgency episodes \>0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.
Percentage change from baseline in urgency episodes was calculated as change in mean number of urgency episodes per 24 hours at that visit divided by the baseline mean number of urgency episodes per 24 hours, multiplied by 100.
Outcome measures
| Measure |
Fesoterodine
n=330 Participants
Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
|
|---|---|
|
Percentage Change From Baseline in Urgency Episodes Per 24 Hours at Weeks 4 and 12
Week 4 (n=303)
|
-40.69 Percentage Change
Interval -46.11 to -35.27
|
|
Percentage Change From Baseline in Urgency Episodes Per 24 Hours at Weeks 4 and 12
Week 12 (n=317)
|
-51.75 Percentage Change
Interval -57.26 to -46.23
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: FAS; participants reporting this symptom at baseline (participants with NUEs \>0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.
NUEs were defined as those with a USS rating of \>=3 in the diary, occurring between the time the participant goes to bed and the time he/she arises to start the next day. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Mean number of NUEs per 24 hours was calculated as total number of NUEs divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of NUEs relative to baseline=improvement.
Outcome measures
| Measure |
Fesoterodine
n=307 Participants
Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
|
|---|---|
|
Change From Baseline in Mean Number of Nocturnal Urgency Episodes (NUEs) Per 24 Hours at Weeks 4 and 12
Week 4 (n=284)
|
-0.95 Number of Episodes
Interval -1.1 to -0.8
|
|
Change From Baseline in Mean Number of Nocturnal Urgency Episodes (NUEs) Per 24 Hours at Weeks 4 and 12
Week 12 (n=297)
|
-1.16 Number of Episodes
Interval -1.32 to -1.01
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: FAS; participants reporting this symptom at baseline (participants with NUEs \>0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.
Percentage change from baseline in NUEs was calculated as change in mean number of NUEs per 24 hours at that visit divided by the baseline mean number of NUEs per 24 hours, multiplied by 100.
Outcome measures
| Measure |
Fesoterodine
n=307 Participants
Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
|
|---|---|
|
Percentage Change From Baseline in NUEs Per 24 Hours at Weeks 4 and 12
Week 4 (n=284)
|
-38.71 Percentage Change
Interval -45.07 to -32.35
|
|
Percentage Change From Baseline in NUEs Per 24 Hours at Weeks 4 and 12
Week 12 (n=297)
|
-44.78 Percentage Change
Interval -53.41 to -36.14
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: FAS; participants reporting this symptom at baseline (participants with SUEs \>0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.
SUEs were defined as those with a USS rating of \>=4 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Mean number of SUEs per 24 hours was calculated as total number of SUEs divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of SUEs relative to baseline=improvement.
Outcome measures
| Measure |
Fesoterodine
n=289 Participants
Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
|
|---|---|
|
Change From Baseline in Mean Number of Severe Urgency Episodes (SUEs) Per 24 Hours at Weeks 4 and 12
Week 4 (n=268)
|
-2.31 Number of Episodes
Interval -2.72 to -1.9
|
|
Change From Baseline in Mean Number of Severe Urgency Episodes (SUEs) Per 24 Hours at Weeks 4 and 12
Week 12 (n=278)
|
-2.93 Number of Episodes
Interval -3.36 to -2.5
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: FAS; participants reporting this symptom at baseline (participants with SUEs \>0 per 24 hours during the 3-day baseline diary period. n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.
Percentage change from baseline in SUEs was calculated as the change in mean number of SUEs per 24 hours at that visit divided by the baseline mean number of SUEs per 24 hours, multiplied by 100.
Outcome measures
| Measure |
Fesoterodine
n=289 Participants
Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
|
|---|---|
|
Percentage Change From Baseline in SUEs Per 24 Hours at Weeks 4 and 12
Week 4 (n=268)
|
-57.37 Percentage Change
Interval -65.2 to -49.55
|
|
Percentage Change From Baseline in SUEs Per 24 Hours at Weeks 4 and 12
Week 12 (n=278)
|
-69.14 Percentage Change
Interval -77.12 to -61.16
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: FAS. n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.
The mean number of incontinence pads used per 24 hours was calculated as the total number of incontinence pads used divided by the total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of incontinence pads used relative to baseline=improvement.
Outcome measures
| Measure |
Fesoterodine
n=330 Participants
Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
|
|---|---|
|
Change From Baseline in Mean Number of Incontinence Pads Used Per 24 Hours at Weeks 4 and 12
Week 4 (n=304)
|
-0.49 Number of Incontinence Pads
Interval -0.63 to -0.35
|
|
Change From Baseline in Mean Number of Incontinence Pads Used Per 24 Hours at Weeks 4 and 12
Week 12 (n=316)
|
-0.64 Number of Incontinence Pads
Interval -0.79 to -0.49
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: FAS; n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.
PPBC: self-administered, single-item, questionnaire to describe perception of participants bladder-related problems (rated on 6-point scale: 1=no problems at all, 2=some very minor, 3=some minor, 4=some moderate, 5=severe, 6=many severe problems). Score change=score at observation minus score at baseline; re-scaled to 4-point categorical variables (major improvement \[score difference \<=-2\]; minor improvement \[score difference =-1\]; no change \[score difference = 0\]; deterioration \[score difference \>=1\]), based on PPBC score.
Outcome measures
| Measure |
Fesoterodine
n=330 Participants
Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
|
|---|---|
|
Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Weeks 4 and 12
Major Improvement (Week 4), n=307
|
86 Participants
|
|
Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Weeks 4 and 12
Minor Improvement (Week 4), n=307
|
121 Participants
|
|
Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Weeks 4 and 12
No Change (Week 4), n=307
|
93 Participants
|
|
Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Weeks 4 and 12
Deterioration (Week 4), n=307
|
7 Participants
|
|
Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Weeks 4 and 12
Major Improvement (Week 12), n=322
|
160 Participants
|
|
Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Weeks 4 and 12
Minor Improvement (Week 12), n=322
|
94 Participants
|
|
Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Weeks 4 and 12
No Change (Week 12), n=322
|
64 Participants
|
|
Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Weeks 4 and 12
Deterioration (Week 12), n=322
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: FAS; n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.
UPS: self-administered, single-item questionnaire to measure participant's perception of urinary urgency (rated on 3-point scale: 1=usually not able to hold urine; 3=usually able to finish what I am doing before going to toilet without leaking). Score change=score at observation minus score at baseline; re-scaled to 3-point categorical variables (improvement \[Increase of 1 or more points in difference of scores\]; no change \[score difference=0\]; deterioration \[Negative difference of scores\], based on UPS score, with number of participants in each of the 3-point categories.
Outcome measures
| Measure |
Fesoterodine
n=330 Participants
Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
|
|---|---|
|
Change From Baseline in Urgency Perception Scale (UPS) at Weeks 4 and 12
Improvement (Week 4), n=307
|
105 Participants
|
|
Change From Baseline in Urgency Perception Scale (UPS) at Weeks 4 and 12
No Change (Week 4), n=307
|
189 Participants
|
|
Change From Baseline in Urgency Perception Scale (UPS) at Weeks 4 and 12
Deterioration (Week 4), n=307
|
13 Participants
|
|
Change From Baseline in Urgency Perception Scale (UPS) at Weeks 4 and 12
Improvement (Week 12), n=321
|
154 Participants
|
|
Change From Baseline in Urgency Perception Scale (UPS) at Weeks 4 and 12
No Change (Week 12), n=321
|
159 Participants
|
|
Change From Baseline in Urgency Perception Scale (UPS) at Weeks 4 and 12
Deterioration (Week 12), n=321
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: FAS. N=number of participants with baseline score. n=number of participants analyzed at specified timepoint. Missing data at Week 12 imputed using LOCF approach.
OAB-q symptom bother scale (8 items) is part of the OAB-q. Symptom bother score=sum of scores for items 1 to 8 (each symptom bother item measured on 6-point Likert scale ranging from 1 (not at all) to 6 (a very great deal). Lowest possible raw score=8; highest possible score=48. Data analyzed based on transformation of score to a 0 to 100 scale: (Actual total raw score - lowest possible value of raw score)/raw score range \* 100. 0=no symptom bother, 100=high symptom bother. Change=mean score at observation minus mean score at baseline, negative change in score=improvement.
Outcome measures
| Measure |
Fesoterodine
n=327 Participants
Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
|
|---|---|
|
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Weeks 4 and 12
Week 4 (n=300)
|
-27.95 Score on Scale
Interval -30.41 to -25.5
|
|
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Weeks 4 and 12
Week 12 (n=319)
|
-37.25 Score on Scale
Interval -39.83 to -34.66
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS. N=number of participants with analyzable data.
ICIQ-SF: self-administered questionnaire for assessment and quantification of incontinence and its impact on quality of life. ICIQ score=sum of the responses to 3 questions: How often do you leak urine? (range: 0=never to 5=all the time); How much urine do you usually leak? (range: 0=none to 6=a large amount); Overall, how much does leaking urine interfere with your everyday life? (range: 0=not at all to 10=a great deal). Score range=0 (low bother from urine leakage) to 21 (maximum bother). Negative change (decrease) from baseline in score value=reduced level of bother.
Outcome measures
| Measure |
Fesoterodine
n=305 Participants
Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
|
|---|---|
|
Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score at Week 12
|
-5.13 Score on Scale
Interval -5.72 to -4.54
|
SECONDARY outcome
Timeframe: Week 12 (or Early Withdrawal)Population: FAS, LOCF.
BSW: 3-item questionnaire to assess participants perception of effect of treatment in terms of treatment benefit, satisfaction with treatment, and participants willingness to continue treatment. Response to each item recorded in dichotomous fashion (Benefit: yes/no, yes - little benefit/much benefit; Satisfaction: yes/no, yes - a little satisfied/very satisfied, no - a little dissatisfied/very dissatisfied; Willingness to continue: yes/no, yes - a little bit willing/very willing, no - a little unwilling/very unwilling).
Outcome measures
| Measure |
Fesoterodine
n=330 Participants
Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
|
|---|---|
|
Number of Participants With Each Categorical Response at Week 12 for Benefit, Satisfaction and Willingness to Continue (BSW) Questionnaire
Benefit from Treatment - Much Benefit
|
188 Participants
|
|
Number of Participants With Each Categorical Response at Week 12 for Benefit, Satisfaction and Willingness to Continue (BSW) Questionnaire
Benefit from Treatment - Little Benefit
|
82 Participants
|
|
Number of Participants With Each Categorical Response at Week 12 for Benefit, Satisfaction and Willingness to Continue (BSW) Questionnaire
Benefit from Treatment - No
|
36 Participants
|
|
Number of Participants With Each Categorical Response at Week 12 for Benefit, Satisfaction and Willingness to Continue (BSW) Questionnaire
Satisfied with Treatment - Yes
|
253 Participants
|
|
Number of Participants With Each Categorical Response at Week 12 for Benefit, Satisfaction and Willingness to Continue (BSW) Questionnaire
Satisfied with Treatment - No
|
54 Participants
|
|
Number of Participants With Each Categorical Response at Week 12 for Benefit, Satisfaction and Willingness to Continue (BSW) Questionnaire
Satisfied with Treatment - Yes (Very Satisfied)
|
184 Participants
|
|
Number of Participants With Each Categorical Response at Week 12 for Benefit, Satisfaction and Willingness to Continue (BSW) Questionnaire
Satisfied with Treatment - Yes (Little Satisfied)
|
69 Participants
|
|
Number of Participants With Each Categorical Response at Week 12 for Benefit, Satisfaction and Willingness to Continue (BSW) Questionnaire
Satisfied with Treatment - No(Little Dissatisfied)
|
30 Participants
|
|
Number of Participants With Each Categorical Response at Week 12 for Benefit, Satisfaction and Willingness to Continue (BSW) Questionnaire
Satisfied with Treatment - No (Very Dissatisfied)
|
24 Participants
|
|
Number of Participants With Each Categorical Response at Week 12 for Benefit, Satisfaction and Willingness to Continue (BSW) Questionnaire
Willingness to Continue - Yes
|
248 Participants
|
|
Number of Participants With Each Categorical Response at Week 12 for Benefit, Satisfaction and Willingness to Continue (BSW) Questionnaire
Willingness to Continue - No
|
61 Participants
|
|
Number of Participants With Each Categorical Response at Week 12 for Benefit, Satisfaction and Willingness to Continue (BSW) Questionnaire
Willingness to Continue - Yes (Very Willing)
|
203 Participants
|
|
Number of Participants With Each Categorical Response at Week 12 for Benefit, Satisfaction and Willingness to Continue (BSW) Questionnaire
Willingness to Continue - Yes (Little Bit Willing)
|
45 Participants
|
|
Number of Participants With Each Categorical Response at Week 12 for Benefit, Satisfaction and Willingness to Continue (BSW) Questionnaire
Willingness to Continue - No (Little Unwilling)
|
23 Participants
|
|
Number of Participants With Each Categorical Response at Week 12 for Benefit, Satisfaction and Willingness to Continue (BSW) Questionnaire
Willingness to Continue - No (Very Unwilling)
|
36 Participants
|
SECONDARY outcome
Timeframe: Week 12 (or Early Withdrawal)Population: FAS. N=number of participants with analyzable data.
TSQ: Independent component of the overactive bladder TSQ. Self- administered, 1-item measure of participant satisfaction for participants receiving treatment for OAB. The 5 categorical responses were grouped to 'Satisfied' (including 'very satisfied' and 'somewhat satisfied') and 'Dissatisfied' (including 'very dissatisfied','somewhat dissatisfied', and 'neither dissatisfied nor satisfied'). Percentage of participants reporting satisfaction included those with categorical responses of 'very satisfied' and 'somewhat satisfied'.
Outcome measures
| Measure |
Fesoterodine
n=307 Participants
Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
|
|---|---|
|
Percentage of Participants Reporting Satisfaction on the Treatment Satisfaction Questionnaire (TSQ) at Week 12
|
73.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS. n=number of participants with analyzable data.
KHQ: Self-administered questionnaire containing 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, severity of urinary symptoms). Each domain was a categorical scale that was converted to a numeric score. All domains transformed to a range of 0 to 100, where 0=best outcome/response and 100=worst outcome/response. Change=mean score at Week 12 minus mean score at baseline, negative change from baseline=improvement.
Outcome measures
| Measure |
Fesoterodine
n=330 Participants
Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
|
|---|---|
|
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12
General Health Perception (n=311)
|
-2.57 Score on Scale
Interval -4.81 to -0.34
|
|
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12
Incontinence Impact (n=309)
|
-29.69 Score on Scale
Interval -32.22 to -27.17
|
|
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12
Role Limitations (n=311)
|
-41.16 Score on Scale
Interval -44.57 to -37.75
|
|
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12
Physical Limitations (n=311)
|
-36.60 Score on Scale
Interval -40.1 to -33.1
|
|
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12
Social Limitations (n=310)
|
-25.22 Score on Scale
Interval -28.38 to -22.05
|
|
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12
Personal Relationships (n=220)
|
-15.23 Score on Scale
Interval -18.77 to -11.69
|
|
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12
Emotions (n=308)
|
-25.78 Score on Scale
Interval -28.91 to -22.64
|
|
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12
Sleep/Energy (n=311)
|
-21.38 Score on Scale
Interval -24.3 to -18.47
|
|
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12
Severity of Urinary Symptoms (n=311)
|
-21.92 Score on Scale
Interval -24.49 to -19.34
|
Adverse Events
Fesoterodine
Serious adverse events
| Measure |
Fesoterodine
n=331 participants at risk
Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
0.30%
1/331
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Myocardial infarction
|
0.30%
1/331
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Palpitations
|
0.30%
1/331
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Keratitis
|
0.30%
1/331
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastritis
|
0.30%
1/331
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest discomfort
|
0.30%
1/331
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
0.60%
2/331
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Diverticulitis
|
0.60%
2/331
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.30%
1/331
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.30%
1/331
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
0.30%
1/331
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.30%
1/331
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.30%
1/331
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.30%
1/331
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.30%
1/331
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
0.30%
1/331
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Fesoterodine
n=331 participants at risk
Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
|
|---|---|
|
Eye disorders
Dry eye
|
2.4%
8/331
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
9.1%
30/331
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.8%
29/331
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
29.9%
99/331
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.1%
17/331
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
4.5%
15/331
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
2.7%
9/331
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
7.9%
26/331
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
8/331
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
3.3%
11/331
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
5.4%
18/331
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.1%
7/331
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
2.1%
7/331
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER