Trial Outcomes & Findings for Fesoterodine Flexible Dose Study (NCT NCT00536484)
NCT ID: NCT00536484
Last Updated: 2009-09-15
Results Overview
The number of micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Change: mean at Week 12 minus mean at Baseline
COMPLETED
PHASE3
896 participants
Baseline and Week 12
2009-09-15
Participant Flow
Participants were screened at 90 centers in the United States; in 88 centers, participants were randomized.
The study consisted of a 2-week no-treatment screening period and a 12-week double-blind treatment period. Participants with bothersome overactive bladder (OAB) symptoms who met all entry criteria at baseline (end of screening) were randomized.
Participant milestones
| Measure |
Placebo
All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
|
Fesoterodine
All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
|
|---|---|---|
|
Overall Study
STARTED
|
445
|
438
|
|
Overall Study
COMPLETED
|
385
|
382
|
|
Overall Study
NOT COMPLETED
|
60
|
56
|
Reasons for withdrawal
| Measure |
Placebo
All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
|
Fesoterodine
All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
|
|---|---|---|
|
Overall Study
Adverse Event
|
21
|
34
|
|
Overall Study
Withdrawal by Subject
|
11
|
11
|
|
Overall Study
Lost to Follow-up
|
8
|
6
|
|
Overall Study
Lack of Efficacy
|
16
|
5
|
|
Overall Study
Other
|
4
|
0
|
Baseline Characteristics
Fesoterodine Flexible Dose Study
Baseline characteristics by cohort
| Measure |
Placebo
n=445 Participants
All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
|
Fesoterodine
n=438 Participants
All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
|
Total
n=883 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
60.1 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
59.7 years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
59.9 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
368 Participants
n=5 Participants
|
364 Participants
n=7 Participants
|
732.0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
151.0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (last observation carried forward \[LOCF)). The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 valid efficacy assessment, either at baseline or post baseline.
The number of micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Change: mean at Week 12 minus mean at Baseline
Outcome measures
| Measure |
Placebo
n=434 Participants
All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
|
Fesoterodine
n=428 Participants
All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
|
|---|---|---|
|
Change in Mean Number of Micturition Episodes Per 24 Hours at Week 12 Relative to Baseline.
|
-2.1 number of episodes per 24 hours
Standard Error 0.1
|
-2.9 number of episodes per 24 hours
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline, Week 2 and Week 6Population: Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 2 or Week 6 (last observation carried forward \[LOCF\]). The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 valid efficacy assessment, either at baseline or post baseline (n=placebo; n=fesoterodine)
The number of micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Change: mean at observation minus mean at baseline
Outcome measures
| Measure |
Placebo
n=445 Participants
All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
|
Fesoterodine
n=435 Participants
All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
|
|---|---|---|
|
Change in Mean Number of Micturition Episodes Per 24 Hours Relative to Baseline
Week 2 (n=431; n=427)
|
-1.3 number of episodes per 24 hours
Standard Error 0.1
|
-1.8 number of episodes per 24 hours
Standard Error 0.1
|
|
Change in Mean Number of Micturition Episodes Per 24 Hours Relative to Baseline
Week 6 (n=434; n=428)
|
-2.0 number of episodes per 24 hours
Standard Error 0.1
|
-2.7 number of episodes per 24 hours
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6 and Week 12Population: Number of subjects with Baseline Urgency Episodes \>0 per 24 hours and non missing change from baseline to Week 2, Week 6 (last observation carried forward \[LOCF\]) or Week 12 (LOCF). Only subjects with at least 1 episode during baseline 3-day diary period were included in analysis.
Change in number of urgency episodes (urinary sensation scale \[USS\] rating of 3 or more) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine. The number of urgency episodes per 24 hours was calculated as the sum of all urgency episodes divided by the total number of diary days collected at that visit.
Outcome measures
| Measure |
Placebo
n=444 Participants
All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
|
Fesoterodine
n=437 Participants
All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
|
|---|---|---|
|
Change in Number of Urgency Episodes Per 24 Hours Relative to Baseline
Week 2 (n=431; n=427)
|
-1.9 number of episodes per 24 hours
Standard Error 0.2
|
-2.3 number of episodes per 24 hours
Standard Error 0.2
|
|
Change in Number of Urgency Episodes Per 24 Hours Relative to Baseline
Week 6 (n=434; n=428)
|
-2.9 number of episodes per 24 hours
Standard Error 0.2
|
-3.5 number of episodes per 24 hours
Standard Error 0.2
|
|
Change in Number of Urgency Episodes Per 24 Hours Relative to Baseline
Week 12 (n=434; n=428)
|
-3.0 number of episodes per 24 hours
Standard Error 0.2
|
-4.0 number of episodes per 24 hours
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6 and Week 12Population: Number of subjects with baseline severe urgency episodes \>0 per 24 hours and non-missing change from baseline to Week 2, Week 6 (last observation carried forward \[LOCF\]) or Week 12 (LOCF). Only those with at least 1 episode during baseline 3-day diary period were included.
Change in number of severe urgency episodes (urinary sensation scale \[USS\] rating of 4 or more) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine. Number of severe urgency episodes per 24 hours calculated as sum of all severe urgency episodes divided by total number of diary days collected at that visit.
Outcome measures
| Measure |
Placebo
n=405 Participants
All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
|
Fesoterodine
n=412 Participants
All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
|
|---|---|---|
|
Change in Number of Severe Urgency Episodes Per 24 Hours Relative to Baseline
Week 2 (n=393; n=403)
|
-1.6 number of episodes per 24 hours
Standard Error 0.1
|
-1.8 number of episodes per 24 hours
Standard Error 0.1
|
|
Change in Number of Severe Urgency Episodes Per 24 Hours Relative to Baseline
Week 6 (n=396; n=404)
|
-2.2 number of episodes per 24 hours
Standard Error 0.1
|
-2.6 number of episodes per 24 hours
Standard Error 0.1
|
|
Change in Number of Severe Urgency Episodes Per 24 Hours Relative to Baseline
Week 12 (n=396; n=404)
|
-2.2 number of episodes per 24 hours
Standard Error 0.1
|
-2.9 number of episodes per 24 hours
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6 and Week 12Population: Number of subjects with Baseline UUI \>0 per 24 hours and non-missing change from baseline to Week 2, Week 6 (last observation carried forward \[LOCF\]) or Week 12 (LOCF). Only subjects with at least 1 episode during baseline 3-day diary period were included in analysis.
Change in number of UUI episodes (urinary sensation scale \[USS\] rating of 5) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine
Outcome measures
| Measure |
Placebo
n=260 Participants
All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
|
Fesoterodine
n=257 Participants
All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
|
|---|---|---|
|
Change in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours Relative to Baseline
week 12 (n=257; n=251)
|
-1.2 number of episodes per 24 hours
Standard Error 0.1
|
-1.5 number of episodes per 24 hours
Standard Error 0.1
|
|
Change in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours Relative to Baseline
Week 2 (n=255; n=251)
|
-0.9 number of episodes per 24 hours
Standard Error 0.1
|
-1.1 number of episodes per 24 hours
Standard Error 0.1
|
|
Change in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours Relative to Baseline
Week 6 (n=257; n=251)
|
-1.2 number of episodes per 24 hours
Standard Error 0.1
|
-1.5 number of episodes per 24 hours
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6 and Week 12Population: Number of subjects with Baseline Nocturnal Micturitions \>0 per 24 and non-missing change from baseline to Week 2, Week 6 (last observation carried forward \[LOCF\]) or Week 12 (LOCF). Only subjects with at least 1 episode during baseline 3-day diary period were included in analysis.
Change in number of nocturnal micturitions (NM) recorded in the bladder diary. NM were defined as micturitions that occurred between the time the subject went to bed and the time he or she arose to start the next day. The number of NM per 24 hours was calculated as the sum of all NM divided by the total number of diary days collected at that visit.
Outcome measures
| Measure |
Placebo
n=433 Participants
All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
|
Fesoterodine
n=427 Participants
All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
|
|---|---|---|
|
Change in Nocturnal Micturition Episodes Per 24 Hours Relative to Baseline
Week 2 (n=420; n=417)
|
-0.5 number of episodes per 24 hours
Standard Error 0.1
|
-0.5 number of episodes per 24 hours
Standard Error 0.1
|
|
Change in Nocturnal Micturition Episodes Per 24 Hours Relative to Baseline
Week 6 (n=423; n=418)
|
-0.7 number of episodes per 24 hours
Standard Error 0.1
|
-0.7 number of episodes per 24 hours
Standard Error 0.1
|
|
Change in Nocturnal Micturition Episodes Per 24 Hours Relative to Baseline
Week 12 (n=423; n=418)
|
-0.7 number of episodes per 24 hours
Standard Error 0.1
|
-0.8 number of episodes per 24 hours
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6 and Week 12Population: Number of subjects with Nocturnal Urgency Episodes \>0 per 24 hours and non-missing change from baseline to Week 2, Week 6 (last observation carried forward \[LOCF\]) or Week 12 (LOCF). Only subjects with at least 1 episode during baseline 3-day diary period were included in analysis.
Change in number of nocturnal urgency episodes (NUE) recorded in bladder diary. NUE had urinary sensation scale (USS) rating of 3 or more that occurred between time subject went to bed and time he or she arose to start next day. Number of NUE per 24 hours was calculated as sum of all NUE divided by total number of diary days collected at that visit
Outcome measures
| Measure |
Placebo
n=424 Participants
All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
|
Fesoterodine
n=418 Participants
All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
|
|---|---|---|
|
Change in Number of Nocturnal Urgency Episodes Per 24 Hours Relative to Baseline
Week 2 (n=411; n=408)
|
-0.6 number of episodes per 24 hours
Standard Error 0.1
|
-0.6 number of episodes per 24 hours
Standard Error 0.1
|
|
Change in Number of Nocturnal Urgency Episodes Per 24 Hours Relative to Baseline
Week 6 (n=414; n=409)
|
-0.8 number of episodes per 24 hours
Standard Error 0.1
|
-0.9 number of episodes per 24 hours
Standard Error 0.1
|
|
Change in Number of Nocturnal Urgency Episodes Per 24 Hours Relative to Baseline
Week 12 (n=414; n=409)
|
-0.9 number of episodes per 24 hours
Standard Error 0.1
|
-1.0 number of episodes per 24 hours
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6 and Week 12Population: Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 2, Week 6 or Week 12 (last observation carried forward \[LOCF\]). Number analyzed=participants at Week 12 LOCF.
Change in frequency urgency sum is total urinary sensation scale (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
Outcome measures
| Measure |
Placebo
n=445 Participants
All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
|
Fesoterodine
n=435 Participants
All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
|
|---|---|---|
|
Change in Frequency-urgency Sum Per 24 Hours Relative to Baseline
Week 2 (n=431; n=427)
|
-6.5 scores on a scale
Standard Error 0.5
|
-8.3 scores on a scale
Standard Error 0.5
|
|
Change in Frequency-urgency Sum Per 24 Hours Relative to Baseline
Week 6 (n=434; n=428)
|
-9.8 scores on a scale
Standard Error 0.6
|
-12.5 scores on a scale
Standard Error 0.6
|
|
Change in Frequency-urgency Sum Per 24 Hours Relative to Baseline
Week 12 (n=434; n=428)
|
-10.3 scores on a scale
Standard Error 0.6
|
-13.6 scores on a scale
Standard Error 0.6
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 valid efficacy assessment, either at baseline or post baseline
Each item rated by subject on a Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0 to 100. Once transformed a negative change indicates improvement. Change: mean at Week 12 minus mean at baseline
Outcome measures
| Measure |
Placebo
n=384 Participants
All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
|
Fesoterodine
n=378 Participants
All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
|
|---|---|---|
|
Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Symptom Bother Scale
|
-20.0 scores on a scale
Standard Error 1.1
|
-27.8 scores on a scale
Standard Error 1.1
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 valid efficacy assessment, either at baseline or post baseline
Each item rated by subject on a Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0 to 100. Once transformed a positive change indicates improvement. Change: mean at Week 12 minus mean at baseline.
Outcome measures
| Measure |
Placebo
n=445 Participants
All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
|
Fesoterodine
n=435 Participants
All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
|
|---|---|---|
|
Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Health Related Quality of Life (HRQL) Subscales
HRQL concern domain (n=383; n=372)
|
20.9 scores on a scale
Standard Error 1.1
|
29.3 scores on a scale
Standard Error 1.2
|
|
Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Health Related Quality of Life (HRQL) Subscales
HRQL coping domain (n=383; n=372)
|
20.2 scores on a scale
Standard Error 1.2
|
27.2 scores on a scale
Standard Error 1.2
|
|
Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Health Related Quality of Life (HRQL) Subscales
HRQL sleep domain (n=383; n=372)
|
21.2 scores on a scale
Standard Error 1.2
|
25.9 scores on a scale
Standard Error 1.2
|
|
Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Health Related Quality of Life (HRQL) Subscales
HRQL social interaction domain (n=380; n=372)
|
11.6 scores on a scale
Standard Error 0.8
|
15.3 scores on a scale
Standard Error 0.8
|
|
Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Health Related Quality of Life (HRQL) Subscales
HRQL scale score total (n=380; n=372)
|
18.9 scores on a scale
Standard Error 1.0
|
25.1 scores on a scale
Standard Error 1.0
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6 and Week 12Population: Participants in the Full Analysis Set (FAS) with non-missing baseline values and Week 2, Week 6 (last observation carried forward \[LOCF\]) or Week 12 (LOCF) values. Number analyzed=participants at Week 12 LOCF.
PPBC scale range: 1='does not cause me any problems at all' to 6='causes me many severe problems'. Major improvement=negative score change of 2 or more from baseline; minor improvement=negative score change of 1 or more from baseline; no change=0 score change from baseline; Deterioration=positive score change from baseline
Outcome measures
| Measure |
Placebo
n=445 Participants
All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
|
Fesoterodine
n=435 Participants
All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
|
|---|---|---|
|
Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to Baseline
Week 2 (n=440; n=434): major improvement
|
13.2 percentage of participants
|
16.6 percentage of participants
|
|
Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to Baseline
Week 2: minor improvement
|
34.8 percentage of participants
|
39.4 percentage of participants
|
|
Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to Baseline
Week 2: no change
|
45.2 percentage of participants
|
39.4 percentage of participants
|
|
Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to Baseline
Week 2: deterioration
|
6.8 percentage of participants
|
4.6 percentage of participants
|
|
Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to Baseline
Week 6 (n=442; n=435): major improvement
|
24.7 percentage of participants
|
32.4 percentage of participants
|
|
Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to Baseline
Week 6: minor improvement
|
34.8 percentage of participants
|
35.9 percentage of participants
|
|
Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to Baseline
Week 6: no change
|
33.5 percentage of participants
|
27.8 percentage of participants
|
|
Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to Baseline
Week 6: deterioration
|
7.0 percentage of participants
|
3.9 percentage of participants
|
|
Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to Baseline
Week 12 (n=442; n=435): major improvement
|
29.2 percentage of participants
|
36.8 percentage of participants
|
|
Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to Baseline
Week 12: minor improvement
|
31.0 percentage of participants
|
34.5 percentage of participants
|
|
Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to Baseline
Week 12: no change
|
33.0 percentage of participants
|
25.5 percentage of participants
|
|
Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to Baseline
Week 12: deterioration
|
6.8 percentage of participants
|
3.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6 and Week 12Population: Participants in the Full Analysis Set (FAS) with non-missing baseline values and Week 2, Week 6 (last observation carried forward \[LOCF\]) or Week 12 (LOCF) values. Number analyzed=participants at Week 12 LOCF.
UPS scores range from 0 ("I am usually not able to hold urine") to 2 ("I am usually able to finish what I am doing before going to the toilet \[without leaking\]"). Improvement: positive score change; No change: score change=0; Deterioration: negative score change
Outcome measures
| Measure |
Placebo
n=445 Participants
All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
|
Fesoterodine
n=435 Participants
All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
|
|---|---|---|
|
Categorical Change in Urgency Perception Scale (UPS) Relative to Baseline
Week 2 (n=441; n=434): improvement
|
22.9 percentage of participants
|
29.3 percentage of participants
|
|
Categorical Change in Urgency Perception Scale (UPS) Relative to Baseline
Week 2: no change
|
69.2 percentage of participants
|
64.5 percentage of participants
|
|
Categorical Change in Urgency Perception Scale (UPS) Relative to Baseline
Week 2: deterioration
|
7.9 percentage of participants
|
6.2 percentage of participants
|
|
Categorical Change in Urgency Perception Scale (UPS) Relative to Baseline
Week 6 (n=443; n=435): improvement
|
30.2 percentage of participants
|
37.5 percentage of participants
|
|
Categorical Change in Urgency Perception Scale (UPS) Relative to Baseline
Week 6: no change
|
65.0 percentage of participants
|
58.6 percentage of participants
|
|
Categorical Change in Urgency Perception Scale (UPS) Relative to Baseline
Week 6: deterioration
|
4.7 percentage of participants
|
3.9 percentage of participants
|
|
Categorical Change in Urgency Perception Scale (UPS) Relative to Baseline
Week 12 (n=443; n=435): improvement
|
30.9 percentage of participants
|
41.8 percentage of participants
|
|
Categorical Change in Urgency Perception Scale (UPS) Relative to Baseline
Week 12: no change
|
62.3 percentage of participants
|
52.4 percentage of participants
|
|
Categorical Change in Urgency Perception Scale (UPS) Relative to Baseline
Week 12: deterioration
|
6.8 percentage of participants
|
5.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6 and Week 12Population: Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 2, Week 6 or Week 12 (last observation carried forward \[LOCF\]). Number analyzed=participants at Week 12 LOCF
The urgency severity VAS Scale records the subject's assessment of the severity of urgency. VAS scale ranges from 1 'Very Mild' to 10 'Very Severe'. Negative change indicated improvement. Change: mean at observation minus mean at baseline.
Outcome measures
| Measure |
Placebo
n=445 Participants
All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
|
Fesoterodine
n=435 Participants
All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
|
|---|---|---|
|
Change in Urgency Severity Visual Analog Scale (VAS) Relative to Baseline
Week 2 (n=441; n=432)
|
-0.8 scores on a scale
Standard Error 0.1
|
-1.4 scores on a scale
Standard Error 0.1
|
|
Change in Urgency Severity Visual Analog Scale (VAS) Relative to Baseline
Week 6 (n=443; n=434)
|
-1.4 scores on a scale
Standard Error 0.1
|
-2.2 scores on a scale
Standard Error 0.1
|
|
Change in Urgency Severity Visual Analog Scale (VAS) Relative to Baseline
Week 12 (n=443; n=434)
|
-1.4 scores on a scale
Standard Error 0.1
|
-2.4 scores on a scale
Standard Error 0.1
|
Adverse Events
Placebo
Fesoterodine
Serious adverse events
| Measure |
Placebo
All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
|
Fesoterodine
All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
|
|---|---|---|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/445
|
0.23%
1/438
|
|
Gastrointestinal disorders
Nausea
|
0.22%
1/445
|
0.00%
0/438
|
|
Gastrointestinal disorders
Vomiting
|
0.22%
1/445
|
0.00%
0/438
|
|
General disorders
Chest pain
|
0.22%
1/445
|
0.00%
0/438
|
|
Infections and infestations
Cellulitis
|
0.22%
1/445
|
0.00%
0/438
|
|
Infections and infestations
Pneumonia
|
0.45%
2/445
|
0.46%
2/438
|
|
Infections and infestations
Urinary tract infection
|
0.45%
2/445
|
0.00%
0/438
|
|
Injury, poisoning and procedural complications
Fall
|
0.22%
1/445
|
0.00%
0/438
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.22%
1/445
|
0.00%
0/438
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/445
|
0.23%
1/438
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/445
|
0.23%
1/438
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.22%
1/445
|
0.00%
0/438
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/445
|
0.23%
1/438
|
|
Metabolism and nutrition disorders
Dehydration
|
0.22%
1/445
|
0.00%
0/438
|
|
Vascular disorders
Hypotension
|
0.22%
1/445
|
0.00%
0/438
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/445
|
0.23%
1/438
|
Other adverse events
| Measure |
Placebo
All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
|
Fesoterodine
All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
|
|---|---|---|
|
Eye disorders
Dry eye
|
1.8%
8/445
|
3.0%
13/438
|
|
Gastrointestinal disorders
Constipation
|
5.6%
25/445
|
11.0%
48/438
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
19/445
|
2.1%
9/438
|
|
Gastrointestinal disorders
Dry mouth
|
7.6%
34/445
|
25.8%
113/438
|
|
Gastrointestinal disorders
Nausea
|
4.0%
18/445
|
1.4%
6/438
|
|
General disorders
Fatigue
|
0.45%
2/445
|
2.5%
11/438
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
25/445
|
4.3%
19/438
|
|
Infections and infestations
Upper respiratory tract infection
|
5.2%
23/445
|
4.8%
21/438
|
|
Infections and infestations
Urinary tract infection
|
2.7%
12/445
|
1.8%
8/438
|
|
Nervous system disorders
Headache
|
3.4%
15/445
|
4.3%
19/438
|
|
Psychiatric disorders
Insomnia
|
0.45%
2/445
|
2.5%
11/438
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.45%
2/445
|
2.1%
9/438
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.22%
1/445
|
2.1%
9/438
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 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