Urinary Bladder, Overactive
Conditions
Keywords
Fesoterodine, Open Label, Flexible Dose, OAB
Brief summary
To explore the effects of fesoterodine when used in a flexible dose manner
Interventions
DRUGFesoterodine
Fesoterodine 4mg for 4 weeks, escalating to fesoterodine 8mg if tolerated
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female \>18 years old * OAB for \>3 months
Exclusion criteria
* Patients with conditions that would contraindicate for fesoterodine use * Patients with significant hepatic and renal disease or other significant unstable diseases. * OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12 | Baseline, Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline in the Number of Micturitions Per 24 Hours at Weeks 4 and 12 | Baseline, Week 4 and Week 12 | 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. |
| Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12 | Baseline, Week 4 and Week 12 | 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. |
| Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12 | Baseline, Week 4 and Week 12 | 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. |
| Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4 and 12 | Baseline, Week 4 and Week 12 | 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. |
| Percentage Change From Baseline in UUI Episodes Per 24 Hours at Weeks 4 and 12 | Baseline, Week 4 and Week 12 | 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. |
| Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 4 and 12 | Baseline, Week 4 and Week 12 | 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. |
| Percentage Change From Baseline in Urgency Episodes Per 24 Hours at Weeks 4 and 12 | Baseline, Week 4 and Week 12 | 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. |
| Change From Baseline in Mean Number of Nocturnal Urgency Episodes (NUEs) Per 24 Hours at Weeks 4 and 12 | Baseline, Week 4 and Week 12 | 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. |
| Percentage Change From Baseline in NUEs Per 24 Hours at Weeks 4 and 12 | Baseline, Week 4 and Week 12 | 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. |
| Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 | Baseline, Week 4 | 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. |
| Percentage Change From Baseline in SUEs Per 24 Hours at Weeks 4 and 12 | Baseline, Week 4 and Week 12 | 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. |
| Change From Baseline in Mean Number of Incontinence Pads Used Per 24 Hours at Weeks 4 and 12 | Baseline, Week 4 and Week 12 | 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. |
| Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Weeks 4 and 12 | Baseline, Week 4 and Week 12 | 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. |
| Change From Baseline in Urgency Perception Scale (UPS) at Weeks 4 and 12 | Baseline, Week 4 and Week 12 | 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. |
| Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Weeks 4 and 12 | Baseline, Week 4 and Week 12 | 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. |
| Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score at Week 12 | Baseline, Week 12 | 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. |
| Number of Participants With Each Categorical Response at Week 12 for Benefit, Satisfaction and Willingness to Continue (BSW) Questionnaire | Week 12 (or Early Withdrawal) | 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). |
| Percentage of Participants Reporting Satisfaction on the Treatment Satisfaction Questionnaire (TSQ) at Week 12 | Week 12 (or Early Withdrawal) | 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'. |
| Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Baseline, Week 12 | 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. |
| Change From Baseline in Mean Number of Severe Urgency Episodes (SUEs) Per 24 Hours at Weeks 4 and 12 | Baseline, Week 4 and Week 12 | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fesoterodine 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. | 331 |
| Total | 331 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 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
| Characteristic | Fesoterodine |
|---|---|
| Age, Customized >= 65 Years | 131 Participants |
| Age, Customized Between 18 to 44 Years | 37 Participants |
| Age, Customized Between 45 to 64 Years | 163 Participants |
| Sex: Female, Male Female | 263 Participants |
| Sex: Female, Male Male | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 177 / 331 |
| serious Total, serious adverse events | 11 / 331 |
Outcome results
Primary
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12
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.
Time frame: Baseline, Week 12
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Fesoterodine | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12 | -3.26 Number of Episodes |
Secondary
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12
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.
Time frame: Baseline, Week 12
Population: FAS. n=number of participants with analyzable data.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fesoterodine | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | General Health Perception (n=311) | -2.57 Score on Scale |
| Fesoterodine | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Incontinence Impact (n=309) | -29.69 Score on Scale |
| Fesoterodine | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Role Limitations (n=311) | -41.16 Score on Scale |
| Fesoterodine | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Physical Limitations (n=311) | -36.60 Score on Scale |
| Fesoterodine | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Social Limitations (n=310) | -25.22 Score on Scale |
| Fesoterodine | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Personal Relationships (n=220) | -15.23 Score on Scale |
| Fesoterodine | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Emotions (n=308) | -25.78 Score on Scale |
| Fesoterodine | Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | Sleep/Energy (n=311) | -21.38 Score on Scale |
| Fesoterodine | 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 |
Secondary
Change From Baseline in Mean Number of Incontinence Pads Used Per 24 Hours at Weeks 4 and 12
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.
Time frame: Baseline, Week 4 and Week 12
Population: FAS. n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fesoterodine | 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 |
| Fesoterodine | 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 |
Secondary
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4
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.
Time frame: Baseline, Week 4
Population: FAS. N=number of participants with analyzable data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Fesoterodine | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 | -2.55 Number of Episodes |
Secondary
Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12
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.
Time frame: Baseline, Week 4 and Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fesoterodine | 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 |
| Fesoterodine | 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 |
Secondary
Change From Baseline in Mean Number of Nocturnal Urgency Episodes (NUEs) Per 24 Hours at Weeks 4 and 12
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.
Time frame: Baseline, Week 4 and Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fesoterodine | 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 |
| Fesoterodine | 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 |
Secondary
Change From Baseline in Mean Number of Severe Urgency Episodes (SUEs) Per 24 Hours at Weeks 4 and 12
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.
Time frame: Baseline, Week 4 and Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fesoterodine | 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 |
| Fesoterodine | 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 |
Secondary
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 4 and 12
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.
Time frame: Baseline, Week 4 and Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fesoterodine | 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 |
| Fesoterodine | 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 |
Secondary
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4 and 12
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.
Time frame: Baseline, Week 4 and Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fesoterodine | 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 |
| Fesoterodine | 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 |
Secondary
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Weeks 4 and 12
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.
Time frame: Baseline, Week 4 and Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fesoterodine | 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 |
| Fesoterodine | 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 |
Secondary
Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Weeks 4 and 12
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.
Time frame: Baseline, Week 4 and Week 12
Population: FAS; n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fesoterodine | Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Weeks 4 and 12 | Major Improvement (Week 4), n=307 | 86 Participants |
| Fesoterodine | Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Weeks 4 and 12 | Minor Improvement (Week 4), n=307 | 121 Participants |
| Fesoterodine | Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Weeks 4 and 12 | No Change (Week 4), n=307 | 93 Participants |
| Fesoterodine | Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Weeks 4 and 12 | Deterioration (Week 4), n=307 | 7 Participants |
| Fesoterodine | Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Weeks 4 and 12 | Major Improvement (Week 12), n=322 | 160 Participants |
| Fesoterodine | Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Weeks 4 and 12 | Minor Improvement (Week 12), n=322 | 94 Participants |
| Fesoterodine | Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Weeks 4 and 12 | No Change (Week 12), n=322 | 64 Participants |
| Fesoterodine | Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Weeks 4 and 12 | Deterioration (Week 12), n=322 | 4 Participants |
Secondary
Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score at Week 12
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.
Time frame: Baseline, Week 12
Population: FAS. N=number of participants with analyzable data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Fesoterodine | Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score at Week 12 | -5.13 Score on Scale |
Secondary
Change From Baseline in Urgency Perception Scale (UPS) at Weeks 4 and 12
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.
Time frame: Baseline, Week 4 and Week 12
Population: FAS; n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fesoterodine | Change From Baseline in Urgency Perception Scale (UPS) at Weeks 4 and 12 | Improvement (Week 4), n=307 | 105 Participants |
| Fesoterodine | Change From Baseline in Urgency Perception Scale (UPS) at Weeks 4 and 12 | No Change (Week 4), n=307 | 189 Participants |
| Fesoterodine | Change From Baseline in Urgency Perception Scale (UPS) at Weeks 4 and 12 | Deterioration (Week 4), n=307 | 13 Participants |
| Fesoterodine | Change From Baseline in Urgency Perception Scale (UPS) at Weeks 4 and 12 | Improvement (Week 12), n=321 | 154 Participants |
| Fesoterodine | Change From Baseline in Urgency Perception Scale (UPS) at Weeks 4 and 12 | No Change (Week 12), n=321 | 159 Participants |
| Fesoterodine | Change From Baseline in Urgency Perception Scale (UPS) at Weeks 4 and 12 | Deterioration (Week 12), n=321 | 8 Participants |
Secondary
Number of Participants With Each Categorical Response at Week 12 for Benefit, Satisfaction and Willingness to Continue (BSW) Questionnaire
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).
Time frame: Week 12 (or Early Withdrawal)
Population: FAS, LOCF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fesoterodine | 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 |
| Fesoterodine | 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 |
| Fesoterodine | 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 |
| Fesoterodine | 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 |
| Fesoterodine | 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 |
| Fesoterodine | 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 |
| Fesoterodine | 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 |
| Fesoterodine | 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 |
| Fesoterodine | 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 |
| Fesoterodine | 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 |
| Fesoterodine | 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 |
| Fesoterodine | 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 |
| Fesoterodine | 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 |
| Fesoterodine | 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 |
| Fesoterodine | 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
Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12
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.
Time frame: Baseline, Week 4 and Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fesoterodine | Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12 | Week 4 (n=297) | -15.18 Percentage Change |
| Fesoterodine | Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12 | Week 12 (n=309) | -23.35 Percentage Change |
Secondary
Percentage Change From Baseline in NUEs Per 24 Hours at Weeks 4 and 12
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.
Time frame: Baseline, Week 4 and Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fesoterodine | Percentage Change From Baseline in NUEs Per 24 Hours at Weeks 4 and 12 | Week 4 (n=284) | -38.71 Percentage Change |
| Fesoterodine | Percentage Change From Baseline in NUEs Per 24 Hours at Weeks 4 and 12 | Week 12 (n=297) | -44.78 Percentage Change |
Secondary
Percentage Change From Baseline in SUEs Per 24 Hours at Weeks 4 and 12
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.
Time frame: Baseline, Week 4 and Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fesoterodine | Percentage Change From Baseline in SUEs Per 24 Hours at Weeks 4 and 12 | Week 4 (n=268) | -57.37 Percentage Change |
| Fesoterodine | Percentage Change From Baseline in SUEs Per 24 Hours at Weeks 4 and 12 | Week 12 (n=278) | -69.14 Percentage Change |
Secondary
Percentage Change From Baseline in the Number of Micturitions Per 24 Hours at Weeks 4 and 12
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.
Time frame: Baseline, Week 4 and Week 12
Population: FAS. n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fesoterodine | 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 |
| Fesoterodine | 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 |
Secondary
Percentage Change From Baseline in Urgency Episodes Per 24 Hours at Weeks 4 and 12
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.
Time frame: Baseline, Week 4 and Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fesoterodine | Percentage Change From Baseline in Urgency Episodes Per 24 Hours at Weeks 4 and 12 | Week 4 (n=303) | -40.69 Percentage Change |
| Fesoterodine | Percentage Change From Baseline in Urgency Episodes Per 24 Hours at Weeks 4 and 12 | Week 12 (n=317) | -51.75 Percentage Change |
Secondary
Percentage Change From Baseline in UUI Episodes Per 24 Hours at Weeks 4 and 12
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.
Time frame: Baseline, Week 4 and Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fesoterodine | Percentage Change From Baseline in UUI Episodes Per 24 Hours at Weeks 4 and 12 | Week 4 (n=125) | -59.11 Percentage Change |
| Fesoterodine | Percentage Change From Baseline in UUI Episodes Per 24 Hours at Weeks 4 and 12 | Week 12 (n=127) | -79.30 Percentage Change |
Secondary
Percentage of Participants Reporting Satisfaction on the Treatment Satisfaction Questionnaire (TSQ) at Week 12
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'.
Time frame: Week 12 (or Early Withdrawal)
Population: FAS. N=number of participants with analyzable data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fesoterodine | Percentage of Participants Reporting Satisfaction on the Treatment Satisfaction Questionnaire (TSQ) at Week 12 | 73.6 Percentage of Participants |