Urinary Bladder, Overactive
Conditions
Keywords
Non-interventional study fesoterodine educational materials
Brief summary
Collect information on treatment with Toviaz (fesoterodine) under ordinary prescribing conditions, and to investigate whether additional educational information affects satisfaction with treatment as perceived by the patient.
Detailed description
Patients will be identified and monitored during routine clinical practice visits, and will not be specifically selected as this would interfere with the representativeness of the results. The study will be conducted with office-based urologists and office-based general physicians, practitioners and internists (GPs) in Germany, thus representing a wide range of practices and populations. Each urologist or GP may invite patients to participate who have already been diagnosed with overactive bladder and prescribed Toviaz according to their usual standard of care. Study enrollment stopped on December 31, 2011 due to difficulty in recruiting patients. No safety issues were related to the decision to stop patient enrollment.
Interventions
OTHERToviaz(fesoterodine) plus educational materials
Educational materials including the Self-Assessment Goal Achievement (SAGA) tool to support dialogue.
OTHERToviaz(fesoterodine) without educational materials
No educational materials
Sponsors
Pfizer
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with increased urinary frequency and/or imperative urgency and/or urge incontinence, as can occur in patients with overactive bladder syndrome, for whom Toviaz was prescribed for treatment of the symptoms. Patients will complete the OABv8 questionnaire and will need to meet a minimum score in order to be eligible for the study.
Exclusion criteria
Patients who meet the contraindications in the Toviaz prescribing information (active ingredient fesoterodine) will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Satisfied With Treatment at Month 4 | Month 4 | Participant's response to treatment was based on treatment satisfaction questionnaires (TSQ). Participants answered: overall, how satisfied are you with your OAB medication? and were asked to rate this question on 5 point scale as 1=very satisfied, 2=somewhat satisfied, 3= neither dissatisfied nor satisfied, 4=somewhat dissatisfied and 5=very dissatisfied. Five categorical responses were grouped to satisfied (including very satisfied and somewhat satisfied) and dissatisfied (including very dissatisfied, somewhat dissatisfied, and neither dissatisfied nor satisfied). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | Baseline, Week 4, Month 4 | PPBC: single-item, self-administered validated questionnaire. Rated on a 6-point scale: participant was asked: Which of the following statements describes your bladder condition best at the moment? 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. Change from baseline results categorized as deterioration (Positive change from baseline); no Change (scores change=0); minor Improvement (negative score change in magnitude of 1); major improvement (negative score change in magnitude of \>=2). |
| Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4 | Baseline, Week 4, Month 4 | PPUS: single-item, self-administered validated questionnaire. Rated on a 3-point scale: participant was asked: Which of the following would typically describe your experience when you have a desire to urinate? 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change from baseline results categorized as deterioration (Negative change); no change (Score change=0); improvement (Positive change). |
| Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4 | Baseline, Week 4, Month 4 | Participant's response to the treatment was based on treatment satisfaction questionnaires (TSQ). TSQ was rated on a 5-point scale, participant was asked: overall how satisfied are you with your over active bladder (OAB) medication? 1=very satisfied, 2=somewhat satisfied, 3=neither dissatisfied nor satisfied, 4=somewhat dissatisfied, 5=very dissatisfied. Change from baseline results categorized as deterioration (Positive change from baseline);no change (scores change=0);minor improvement (negative score change in magnitude of 1);major improvement (negative score change in magnitude of \>=2). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fesoterodine With Educational Materials Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months. | 330 |
| Fesoterodine Without Educational Materials Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months. | 421 |
| Total | 751 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 12 | 16 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Lack of Efficacy | 16 | 19 |
| Overall Study | Lost to Follow-up | 14 | 24 |
| Overall Study | Other | 6 | 8 |
| Overall Study | Randomized not treated | 4 | 4 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Fesoterodine With Educational Materials | Total | Fesoterodine Without Educational Materials |
|---|---|---|---|
| Age, Customized 18 to 44 years | 20 participants | 39 participants | 19 participants |
| Age, Customized 45 to 64 years | 114 participants | 246 participants | 132 participants |
| Age, Customized Greater than or equal to (>=) 65 years | 196 participants | 466 participants | 270 participants |
| Age, Customized Less than (<) 18 years | 0 participants | 0 participants | 0 participants |
| Sex: Female, Male Female | 239 Participants | 502 Participants | 263 Participants |
| Sex: Female, Male Male | 91 Participants | 249 Participants | 158 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 25 / 342 | 36 / 431 |
| serious Total, serious adverse events | 2 / 342 | 1 / 431 |
Outcome results
Primary
Percentage of Participants Satisfied With Treatment at Month 4
Participant's response to treatment was based on treatment satisfaction questionnaires (TSQ). Participants answered: overall, how satisfied are you with your OAB medication? and were asked to rate this question on 5 point scale as 1=very satisfied, 2=somewhat satisfied, 3= neither dissatisfied nor satisfied, 4=somewhat dissatisfied and 5=very dissatisfied. Five categorical responses were grouped to satisfied (including very satisfied and somewhat satisfied) and dissatisfied (including very dissatisfied, somewhat dissatisfied, and neither dissatisfied nor satisfied).
Time frame: Month 4
Population: Full Analysis Set (FAS) included all participants who had received at least 1 dose of study medication and had provided at least 1 efficacy endpoint at baseline and during the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fesoterodine With Educational Materials | Percentage of Participants Satisfied With Treatment at Month 4 | 79.6 percentage of participants |
| Fesoterodine Without Educational Materials | Percentage of Participants Satisfied With Treatment at Month 4 | 76.1 percentage of participants |
Secondary
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4
PPBC: single-item, self-administered validated questionnaire. Rated on a 6-point scale: participant was asked: Which of the following statements describes your bladder condition best at the moment? 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. Change from baseline results categorized as deterioration (Positive change from baseline); no Change (scores change=0); minor Improvement (negative score change in magnitude of 1); major improvement (negative score change in magnitude of \>=2).
Time frame: Baseline, Week 4, Month 4
Population: FAS included all participants who had received at least 1 dose of study medication and had provided at least 1 efficacy endpoint at baseline and during the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | Baseline: Some minor problems (n=266, 368) | 15 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | Change at Week 4: Minor improvement (n=266, 368) | 90 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | Baseline: Severe problems (n=266, 368) | 145 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | Change at Week 4: Major improvement (n=266, 368) | 107 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | Baseline: Some very minor problems (n=266, 368) | 2 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | Change at Month 4: Deterioration (n=252, 330) | 7 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | Baseline: Many severe problems (n=266, 368) | 28 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | Change at Month 4: No change (n=252, 330) | 32 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | Change at Week 4: Deterioration (n=266, 368) | 12 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | Change at Month 4: Minor improvement (n=252, 330) | 49 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | Baseline: Some moderate problems (n=266, 368) | 75 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | Change at Month 4: Major improvement (n=252, 330) | 164 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | Change at Week 4: No change (n=266, 368) | 57 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | Baseline: No problem at all (n=266, 368) | 1 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | Baseline: Many severe problems (n=266, 368) | 48 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | Baseline: No problem at all (n=266, 368) | 0 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | Baseline: Some very minor problems (n=266, 368) | 3 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | Baseline: Some minor problems (n=266, 368) | 16 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | Baseline: Some moderate problems (n=266, 368) | 122 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | Baseline: Severe problems (n=266, 368) | 179 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | Change at Week 4: Deterioration (n=266, 368) | 14 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | Change at Week 4: No change (n=266, 368) | 93 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | Change at Week 4: Minor improvement (n=266, 368) | 107 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | Change at Week 4: Major improvement (n=266, 368) | 154 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | Change at Month 4: Deterioration (n=252, 330) | 4 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | Change at Month 4: No change (n=252, 330) | 43 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | Change at Month 4: Minor improvement (n=252, 330) | 82 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | Change at Month 4: Major improvement (n=252, 330) | 201 participants |
Secondary
Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4
PPUS: single-item, self-administered validated questionnaire. Rated on a 3-point scale: participant was asked: Which of the following would typically describe your experience when you have a desire to urinate? 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change from baseline results categorized as deterioration (Negative change); no change (Score change=0); improvement (Positive change).
Time frame: Baseline, Week 4, Month 4
Population: FAS included all participants who had received at least 1 dose of study medication and had provided at least 1 efficacy endpoint at baseline and during the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4 | Baseline: Usually able to hold urine (n=252, 351) | 157 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4 | Change at Week 4: Improvement (n=252, 351) | 103 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4 | Change at Week 4: Deterioration (n=252, 351) | 19 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4 | Change at Month 4: Deterioration (n=238, 311) | 29 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4 | Baseline: Usually able to finish (n=252, 351) | 20 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4 | Change at Month 4: No Change (n=238, 311) | 85 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4 | Change at Week 4: No Change (n=252, 351) | 130 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4 | Change at Month 4: Improvement (n=238, 311) | 124 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4 | Baseline: Usually not able hold urine (n=252, 351) | 75 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4 | Change at Month 4: Improvement (n=238, 311) | 170 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4 | Baseline: Usually not able hold urine (n=252, 351) | 116 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4 | Baseline: Usually able to hold urine (n=252, 351) | 186 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4 | Baseline: Usually able to finish (n=252, 351) | 49 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4 | Change at Week 4: Deterioration (n=252, 351) | 28 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4 | Change at Week 4: No Change (n=252, 351) | 174 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4 | Change at Week 4: Improvement (n=252, 351) | 149 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4 | Change at Month 4: Deterioration (n=238, 311) | 32 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4 | Change at Month 4: No Change (n=238, 311) | 109 participants |
Secondary
Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4
Participant's response to the treatment was based on treatment satisfaction questionnaires (TSQ). TSQ was rated on a 5-point scale, participant was asked: overall how satisfied are you with your over active bladder (OAB) medication? 1=very satisfied, 2=somewhat satisfied, 3=neither dissatisfied nor satisfied, 4=somewhat dissatisfied, 5=very dissatisfied. Change from baseline results categorized as deterioration (Positive change from baseline);no change (scores change=0);minor improvement (negative score change in magnitude of 1);major improvement (negative score change in magnitude of \>=2).
Time frame: Baseline, Week 4, Month 4
Population: FAS included all participants who had received at least 1 dose of study medication and had provided at least 1 efficacy endpoint at baseline and during the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4 | Change at Month 4: Deterioration (n=143, 179) | 2 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4 | Change at Week 4: Deterioration (n=144, 203) | 6 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4 | Change at Week 4: Major Improvement (n=144, 203) | 51 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4 | Baseline: Somewhat Satisfied (n=144, 203) | 20 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4 | Change at Month 4: No Change (n=143, 179) | 33 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4 | Baseline:Neither Dissatisfied/Satisfied(n=144,203) | 47 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4 | Change at Month 4: Minor Improvement (n=143, 179) | 51 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4 | Change at Week 4: Minor Improvement (n=144, 203) | 42 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4 | Change at Month 4: Major Improvement (n=143, 179) | 57 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4 | Baseline: Somewhat Dissatisfied (n=144, 203) | 60 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4 | Baseline: Very Satisfied (n=144, 203) | 2 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4 | Baseline: Very Dissatisfied (n=144, 203) | 15 participants |
| Fesoterodine With Educational Materials | Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4 | Change at Week 4: No Change (n=144, 203) | 45 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4 | Baseline: Somewhat Dissatisfied (n=144, 203) | 95 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4 | Change at Week 4: No Change (n=144, 203) | 56 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4 | Change at Week 4: Minor Improvement (n=144, 203) | 56 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4 | Change at Week 4: Major Improvement (n=144, 203) | 75 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4 | Baseline: Very Satisfied (n=144, 203) | 4 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4 | Baseline:Neither Dissatisfied/Satisfied(n=144,203) | 54 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4 | Baseline: Very Dissatisfied (n=144, 203) | 21 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4 | Change at Week 4: Deterioration (n=144, 203) | 16 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4 | Change at Month 4: Deterioration (n=143, 179) | 10 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4 | Change at Month 4: No Change (n=143, 179) | 38 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4 | Change at Month 4: Minor Improvement (n=143, 179) | 48 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4 | Change at Month 4: Major Improvement (n=143, 179) | 83 participants |
| Fesoterodine Without Educational Materials | Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4 | Baseline: Somewhat Satisfied (n=144, 203) | 29 participants |