Trial Outcomes & Findings for A Clinical Trial To Assess Fesoterodine On Treatment Satisfaction And Symptom Improvement In Overactive Bladder Patients (NCT NCT00425100)
NCT ID: NCT00425100
Last Updated: 2018-12-05
Results Overview
The mean number of micturitions per 24 hours is calculated as the total number of micturitions divided by the total number of diary days collected at that visit.
COMPLETED
PHASE3
516 participants
Baseline and Week 12
2018-12-05
Participant Flow
Subjects were enrolled at 59 centers (Belgium 5 centers, Costa Rica 2, Czech Republic 4, Germany 7, Republic of Korea 6, Poland 2, Slovakia 5, Ukraine 5, United States 23). Two centers in the United States did not randomize subjects.
595 subjects were screened. Responses to a 5-day bladder diary (during a 2-week screening period) identified subjects who met all other entry criteria for enrollment for study treatment.
Participant milestones
| Measure |
Open Label-fesoterodine
All enrolled subjects were treated with fesoterodine 4 mg once daily (QD) for 4 weeks followed by either 4 mg QD or 8 mg QD for the remaining 8 weeks of the study.
|
|---|---|
|
Overall Study
STARTED
|
516
|
|
Overall Study
COMPLETED
|
463
|
|
Overall Study
NOT COMPLETED
|
53
|
Reasons for withdrawal
| Measure |
Open Label-fesoterodine
All enrolled subjects were treated with fesoterodine 4 mg once daily (QD) for 4 weeks followed by either 4 mg QD or 8 mg QD for the remaining 8 weeks of the study.
|
|---|---|
|
Overall Study
Adverse Event
|
36
|
|
Overall Study
Lack of Efficacy
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Protocol Violation
|
4
|
|
Overall Study
Withdrawal by Subject
|
7
|
Baseline Characteristics
A Clinical Trial To Assess Fesoterodine On Treatment Satisfaction And Symptom Improvement In Overactive Bladder Patients
Baseline characteristics by cohort
| Measure |
Open Label-fesoterodine
n=516 Participants
All enrolled subjects were treated with fesoterodine 4 mg once daily (QD) for 4 weeks followed by either 4 mg QD or 8 mg QD for the remaining 8 weeks of the study.
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|---|---|
|
Age, Continuous
|
59.6 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
398 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
118 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Subjects 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 subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
The mean number of micturitions per 24 hours is calculated as the total number of micturitions divided by the total number of diary days collected at that visit.
Outcome measures
| Measure |
Open Label Baseline
n=514 Participants
|
Open Label Week 12
n=514 Participants
|
|---|---|---|
|
Mean Number of Micturition Episodes Per 24 Hours
|
12.7 number of episodes
Standard Deviation 3.9
|
9.7 number of episodes
Standard Deviation 3.4
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Subjects 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 subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment. Restricted to subjects with UUI at baseline \>0.
The mean number of UUI episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) = 5 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine.
Outcome measures
| Measure |
Open Label Baseline
n=256 Participants
|
Open Label Week 12
n=256 Participants
|
|---|---|---|
|
Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
|
2.3 number of episodes
Standard Deviation 2.8
|
0.6 number of episodes
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Subjects 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 subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
The mean number of urgency episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) \>= 3 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine.
Outcome measures
| Measure |
Open Label Baseline
n=514 Participants
|
Open Label Week 12
n=514 Participants
|
|---|---|---|
|
Mean Number of Urgency Episodes Per 24 Hours
|
10.0 number of episodes
Standard Deviation 4.5
|
5.0 number of episodes
Standard Deviation 4.7
|
PRIMARY outcome
Timeframe: Week 12Population: Subjects in the Full Analysis Set (FAS) with non-missing value at Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
Number of Participants who responded satisfied = (very satisfied or somewhat satisfied) and dissatisfied = (somewhat dissatisfied or very dissatisfied) to the treatment satisfaction question.
Outcome measures
| Measure |
Open Label Baseline
n=474 Participants
|
Open Label Week 12
|
|---|---|---|
|
Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment
Satisfied (very satisfied or somewhat satisfied)
|
378 participants
|
—
|
|
Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment
Neither dissatisfied nor satisfied
|
42 participants
|
—
|
|
Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment
Dissatisfied (somewhat or very dissatisfied)
|
54 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
Nocturnal micturitions (synonymous with the term "nighttime micturitions") were those recorded in the bedtime section of the bladder diary.
Outcome measures
| Measure |
Open Label Baseline
n=514 Participants
|
Open Label Week 12
n=514 Participants
|
|---|---|---|
|
Nocturnal Micturitions Per 24 Hours
|
2.6 number of nocturnal micturitions
Standard Deviation 1.6
|
1.8 number of nocturnal micturitions
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Subjects in the Full Analysis Set (FAS) with baseline severe urgency episodes \>0 and non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
Severe urgency episodes defined as Urinary Sensation Scale (USS) rating ≥4. Subjects rated the feeling of urgency associated with each micturition episode using USS provided in the bladder diary. Scale ranges from 1=no feeling of urgency to 5=unable to hold; leak urine; decrease indicates an improvement with respect to urgency symptoms.
Outcome measures
| Measure |
Open Label Baseline
n=442 Participants
|
Open Label Week 12
n=442 Participants
|
|---|---|---|
|
Severe Urgency Episodes Per 24 Hours
|
5.0 number of episodes
Standard Deviation 4.4
|
1.5 number of episodes
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
The mean rating was calculated as the sum of rating scores on the Urinary Sensation Scale divided by the total number of micturitions with non-missing rating at that visit. The scale ranges from 1 "no feeling of urgency" to 5 "unable to hold; leak urine."
Outcome measures
| Measure |
Open Label Baseline
n=514 Participants
|
Open Label Week 12
n=514 Participants
|
|---|---|---|
|
Mean Rating on the Urinary Sensation Scale
|
3.2 scores on a scale
Standard Deviation 0.6
|
2.5 scores on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
The PPBC score ranges from 1 "no problems at all" to 6 "many severe problems."
Outcome measures
| Measure |
Open Label Baseline
n=487 Participants
|
Open Label Week 12
n=487 Participants
|
|---|---|---|
|
Patient Perception of Bladder Condition (PPBC) Score
|
4.9 scores on a scale
Standard Deviation 0.7
|
3.1 scores on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Subjects in the Full Analysis Set (FAS) with non-missing change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
Improvement: negative score change; No change: score change=0; Deterioration: positive score change
Outcome measures
| Measure |
Open Label Baseline
n=487 Participants
|
Open Label Week 12
|
|---|---|---|
|
Patient Perception of Bladder Condition (PPBC) Score at Week 12 Relative to Baseline (Categorical Change)
Improvement
|
405 participants
|
—
|
|
Patient Perception of Bladder Condition (PPBC) Score at Week 12 Relative to Baseline (Categorical Change)
No change
|
72 participants
|
—
|
|
Patient Perception of Bladder Condition (PPBC) Score at Week 12 Relative to Baseline (Categorical Change)
Deterioration
|
10 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
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 \[without leaking\]").
Outcome measures
| Measure |
Open Label Baseline
n=485 Participants
|
Open Label Week 12
n=485 Participants
|
|---|---|---|
|
Urgency Perception Scale (UPS)
|
0.8 scores on a scale
Standard Deviation 0.5
|
1.4 scores on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Subjects in the Full Analysis Set (FAS) with non-missing change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
Improvement: positive score change; No improvement: zero or negative score change
Outcome measures
| Measure |
Open Label Baseline
n=485 Participants
|
Open Label Week 12
|
|---|---|---|
|
Urgency Perception Scale (UPS) at Week 12 Relative to Baseline (Categorical Change)
Improvement
|
237 participants
|
—
|
|
Urgency Perception Scale (UPS) at Week 12 Relative to Baseline (Categorical Change)
No improvement
|
248 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.
Outcome measures
| Measure |
Open Label Baseline
n=470 Participants
|
Open Label Week 12
n=470 Participants
|
|---|---|---|
|
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Concern Domain
|
50.5 scores on a scale
Standard Deviation 25.3
|
79.1 scores on a scale
Standard Deviation 21.2
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.
Outcome measures
| Measure |
Open Label Baseline
n=470 Participants
|
Open Label Week 12
n=470 Participants
|
|---|---|---|
|
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Coping Domain
|
44.7 scores on a scale
Standard Deviation 25.3
|
75.3 scores on a scale
Standard Deviation 24.3
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.
Outcome measures
| Measure |
Open Label Baseline
n=470 Participants
|
Open Label Week 12
n=470 Participants
|
|---|---|---|
|
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Sleep Domain
|
47.4 scores on a scale
Standard Deviation 25.5
|
72.3 scores on a scale
Standard Deviation 23.3
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.
Outcome measures
| Measure |
Open Label Baseline
n=470 Participants
|
Open Label Week 12
n=470 Participants
|
|---|---|---|
|
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Social Interaction Domain
|
71.3 scores on a scale
Standard Deviation 23.5
|
88.1 scores on a scale
Standard Deviation 18.6
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.
Outcome measures
| Measure |
Open Label Baseline
n=470 Participants
|
Open Label Week 12
n=470 Participants
|
|---|---|---|
|
Overactive Bladder Questionnaire (OAB-q) - Total Health Related Quality of Life (HRQL) Scale
|
52.2 scores on a scale
Standard Deviation 21.8
|
78.3 scores on a scale
Standard Deviation 20.2
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
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, higher scores represent less favorable outcome.
Outcome measures
| Measure |
Open Label Baseline
n=470 Participants
|
Open Label Week 12
n=470 Participants
|
|---|---|---|
|
Overactive Bladder Questionnaire (OAB-q) - Symptom Bother Scale
|
57.4 scores on a scale
Standard Deviation 18.7
|
28.6 scores on a scale
Standard Deviation 20.2
|
SECONDARY outcome
Timeframe: Week 12Population: Population included subjects in FAS (described above) with non-missing values on OAB-S at Week 12, referred to in table below as All Subjects. Summary was presented for All Subjects and 2 subgroups, based on categorization for treatment satisfaction question used in primary endpoint assessing satisfaction.
Module coded on scale (1-very satisfied to 5-very dissatisfied). Coding reversed algorithmically \& results transformed: total score range 0-100. Higher final response value associated with better satisfaction. Satisfied on TSQ = very or somewhat satisfied; Not satisfied on TSQ =very or somewhat dissatisfied or neither dissatisfied nor satisfied.
Outcome measures
| Measure |
Open Label Baseline
n=473 Participants
|
Open Label Week 12
|
|---|---|---|
|
"Satisfaction With OAB Control" Module of Overactive Bladder (OAB) Treatment Satisfaction Questionnaire (TSQ) (OAB-S)
All Subjects (N=473)
|
74.7 scores on a scale
Standard Deviation 22.3
|
—
|
|
"Satisfaction With OAB Control" Module of Overactive Bladder (OAB) Treatment Satisfaction Questionnaire (TSQ) (OAB-S)
Subjects satisfied on TSQ (n=377)
|
82.7 scores on a scale
Standard Deviation 14.0
|
—
|
|
"Satisfaction With OAB Control" Module of Overactive Bladder (OAB) Treatment Satisfaction Questionnaire (TSQ) (OAB-S)
Subjects not satisfied on TSQ (n=96)
|
43.6 scores on a scale
Standard Deviation 21.5
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.
The sum rating per 24 hours was calculated as the mean rating score on the Urinary Sensation Scale multiplied by the mean number of micturitions per 24 hours at that visit. The scale ranges from 1 "no feeling of urgency" to 5 "unable to hold; leak urine."
Outcome measures
| Measure |
Open Label Baseline
n=514 Participants
|
Open Label Week 12
n=514 Participants
|
|---|---|---|
|
Sum Rating on the Urinary Sensation Scale
|
40.4 scores on a scale
Standard Deviation 15.6
|
25.2 scores on a scale
Standard Deviation 13.2
|
SECONDARY outcome
Timeframe: Week 12Population: Subjects in safety set included subjects who took at least one dose of study drug. Missing responses to the Treatment Satisfaction Question at Week 12 were imputed as not satisfied for calculating the most conservative treatment satisfaction.
Number of participants who responded satisfied = (very satisfied or somewhat satisfied) or dissatisfied = (somewhat dissatisfied or very dissatisfied) to the treatment satisfaction question at Week 12 in the safety set.
Outcome measures
| Measure |
Open Label Baseline
n=516 Participants
|
Open Label Week 12
|
|---|---|---|
|
Treated Subjects Reporting Satisfaction With Their Current OAB Treatment (Supportive Analysis)
Satisfied (very satisfied or somewhat satisfied)
|
378 participants
|
—
|
|
Treated Subjects Reporting Satisfaction With Their Current OAB Treatment (Supportive Analysis)
Neither Dissatisfied nor Satisfied
|
42 participants
|
—
|
|
Treated Subjects Reporting Satisfaction With Their Current OAB Treatment (Supportive Analysis)
Dissatisfied (somewhat or very dissatisfied)
|
54 participants
|
—
|
|
Treated Subjects Reporting Satisfaction With Their Current OAB Treatment (Supportive Analysis)
Missing Response (imputed as dissatisfied)
|
42 participants
|
—
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
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 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
- Publication restrictions are in place
Restriction type: OTHER