Overactive Bladder, Urinary Incontinence
Conditions
Keywords
observational
Brief summary
This is a observational study in patients treated with fesoterodine (Toviaz), who have failed on previous treatment for overactive bladder. It will collect epidemiological data and investigate the efficacy and tolerability of fesoterodine.
Detailed description
patients older than 18 years with overactive bladder after failure of previous antimuscarinic therapy (due to lack of efficacy or intolerance)
Interventions
DRUGfesoterodine
4 mg per 24 hours, possibility to increase to 8 mg depending on efficacy chronic treatment
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients older than 18 years * Patients with OAB after failure of previous antimuscarinic therapy - due to lack of efficacy: persistence of storage symptoms. * Required symptoms: micturition frequency 8 and more / 24 hours and urgency episodes ≥2 per day subjectively perceived as bothersome * Due to intolerance: persistent and/or unacceptable adverse events
Exclusion criteria
* Hypersensitivity to the active substance or to peanut or soya or any of the excipients. * History of acute urinary retention (requiring catheterisation) * Gastric retention * Uncontrolled narrow angle glaucoma * Myasthenia gravis * Severe hepatic impairment (Child Pugh C) * Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe hepatic or renal impairment * Severe ulcerative colitis * Toxic megacolon.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit | Baseline, Month 1, Month 2, Month 3 or Early Termination (ET) | Micturition frequency: mean number of 'day time' (i.e., the time the participant was awake) micturitions per 24 hours and calculated as the total number of 'day time' urinations, divided by the total diary days collected at that visit. |
| Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Baseline, Month 1, Month 2, Month 3 or ET | Nocturnal frequency: mean number of 'night time' (the time the participant was asleep and the urge to urinate woke him/her up) micturitions and calculated as the total number of 'night time' urinations, divided by the total diary days collected at that visit. |
| Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Baseline, Month 1, Month 2, Month 3 or ET | UEF: mean number of micturition related urgency episodes per 24 hours and calculated as the total number of 'urgency' urinations (i.e., sudden urges to urinate and problems to delay micturition) divided by 3 (or if data for 3 days were not available, over the total number of diary days collected at that visit). |
| Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Baseline, Month 1, Month 2, Month 3 or ET | The mean number of UUI episodes: total number of UUI episodes, divided by the total diary days collected at that visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overactive Bladder Questionnaire (OAB-q): Symptom Severity/Bother Scale | Baseline, Month 3 or ET | Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=\[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range\] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity. |
| Change From Baseline in Total Scores of OAB-q at Visit 4 | Baseline, Month 3 or ET | Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=\[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range\] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity. |
| Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4 | Baseline, Month 1, Month 2, Month 3 or ET | The PVR urine volume: measured by an ultrasound scan. |
| Study Doses | Month 3 or ET | Number of subjects that changed doses throughout the study period. |
| Reasons for Study Treatment Dose Changes | Month 3 or ET | Possible change in the dose and the reasons for the change were collected and documented. |
| Time To Onset Of Treatment Response | Month 1, Month 2, Month 3 or ET | Participant's perception of treatment response assessment since the previous visit was noted at each visit. Time to onset of response was calculated in weeks from start of treatment. |
| Patient's Global Evaluation of Fesoterodine | Baseline, Month 3 or ET | The patients global evaluation of study medication was assessed via the question 'how would you rate your overall response to the study medication?' and was assessed on the four point categorical scale, ranging from 'Poor' to 'Excellent'. |
| Clinical Global Evaluation of Fesoterodine | 12 weeks | Clinical global evaluation of study medication was assessed via the question 'how would you rate the study medication the patient received for overactive bladder?,' and was assessed on the four point categorical scale, ranging from 'Poor' to 'Excellent.' |
| Efficacy and Tolerability Compared to Previous Medication (Overall Treatment Effect Scale) at Visit 4 | Month 3 or ET | Overall Treatment Effect Scale: 3 questions from which a numeric score was derived. If a subject answered '(2) About the same' to question 1 then a score of 0 was given. If a subject answered '(1) Worse' to question 1, then a score between -7=a very great deal worse to -1=Almost the same, hardly worse at all was given depending on severity of their symptoms (determined from answer to question 2). If a subject answered '(3) Better' to question 1, then a score ranging from 1=Almost the same, hardly better at all to 7=A very great deal better, depending on their answer to question 3, was given. |
Countries
Slovakia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fesoterodine 4 mg The recommended starting dose was 4 mg once daily. Based upon individual response, the dose was increased to 8 mg once daily. | 823 |
| Total | 823 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Ongoing at Date of Cut-Off | 4 |
Baseline characteristics
| Characteristic | Fesoterodine 4 mg |
|---|---|
| Age, Customized 18-44 years | 102 participants |
| Age, Customized <18 years | 11 participants |
| Age, Customized 44-64 | 497 participants |
| Age, Customized >=65 years | 213 participants |
| Sex: Female, Male Female | 574 Participants |
| Sex: Female, Male Male | 249 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 78 / 823 |
| serious Total, serious adverse events | 0 / 823 |
Outcome results
Primary
Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit
Micturition frequency: mean number of 'day time' (i.e., the time the participant was awake) micturitions per 24 hours and calculated as the total number of 'day time' urinations, divided by the total diary days collected at that visit.
Time frame: Baseline, Month 1, Month 2, Month 3 or Early Termination (ET)
Population: The full analysis set (FAS) included all patients who received at least one dose of the study medication and who had at least one post baseline efficacy measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine 4 mg | Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit | Baseline | 11.661 episodes | Standard Deviation 2.8565 |
| Fesoterodine 4 mg | Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit | Visit 2 (Month 1) | -2.306 episodes | Standard Deviation 1.5773 |
| Fesoterodine 4 mg | Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit | Visit 3 (Month 2) | -3.482 episodes | Standard Deviation 1.9022 |
| Fesoterodine 4 mg | Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit | Visit 4 (Month 3 or ET) | -4.180 episodes | Standard Deviation 2.1018 |
| Fesoterodine 8 mg | Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit | Visit 4 (Month 3 or ET) | -4.000 episodes | Standard Deviation 1.2293 |
| Fesoterodine 8 mg | Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit | Baseline | 10.636 episodes | Standard Deviation 3.4269 |
| Fesoterodine 8 mg | Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit | Visit 3 (Month 2) | -2.848 episodes | Standard Deviation 1.1772 |
| Fesoterodine 8 mg | Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit | Visit 2 (Month 1) | -2.303 episodes | Standard Deviation 1.2863 |
| Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy | Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit | Visit 4 (Month 3 or ET) | -4.031 episodes | Standard Deviation 1.8995 |
| Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy | Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit | Visit 2 (Month 1) | -1.566 episodes | Standard Deviation 1.4241 |
| Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy | Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit | Visit 3 (Month 2) | -3.160 episodes | Standard Deviation 1.7571 |
| Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy | Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit | Baseline | 12.664 episodes | Standard Deviation 2.7612 |
Primary
Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4
Nocturnal frequency: mean number of 'night time' (the time the participant was asleep and the urge to urinate woke him/her up) micturitions and calculated as the total number of 'night time' urinations, divided by the total diary days collected at that visit.
Time frame: Baseline, Month 1, Month 2, Month 3 or ET
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine 4 mg | Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Visit 3 (Month 2) | -1.621 episodes | Standard Deviation 0.9281 |
| Fesoterodine 4 mg | Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Visit 4 (Month 3 or ET) | -1.914 episodes | Standard Deviation 1.082 |
| Fesoterodine 4 mg | Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Visit 2 (Month 1) | -1.104 episodes | Standard Deviation 0.796 |
| Fesoterodine 4 mg | Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Baseline | 3.027 episodes | Standard Deviation 1.2593 |
| Fesoterodine 8 mg | Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Baseline | 4.000 episodes | Standard Deviation 1.422 |
| Fesoterodine 8 mg | Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Visit 2 (Month 1) | -1.212 episodes | Standard Deviation 0.8065 |
| Fesoterodine 8 mg | Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Visit 4 (Month 3 or ET) | -2.030 episodes | Standard Deviation 1.3035 |
| Fesoterodine 8 mg | Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Visit 3 (Month 2) | -1.848 episodes | Standard Deviation 1.129 |
| Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy | Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Visit 4 (Month 3 or ET) | -2.072 episodes | Standard Deviation 1.0907 |
| Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy | Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Baseline | 3.528 episodes | Standard Deviation 1.3452 |
| Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy | Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Visit 2 (Month 1) | -0.915 episodes | Standard Deviation 0.9115 |
| Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy | Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Visit 3 (Month 2) | -1.613 episodes | Standard Deviation 1.0928 |
Primary
Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4
UEF: mean number of micturition related urgency episodes per 24 hours and calculated as the total number of 'urgency' urinations (i.e., sudden urges to urinate and problems to delay micturition) divided by 3 (or if data for 3 days were not available, over the total number of diary days collected at that visit).
Time frame: Baseline, Month 1, Month 2, Month 3 or ET
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine 4 mg | Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Baseline | 4.412 episodes | Standard Deviation 2.4355 |
| Fesoterodine 4 mg | Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Visit 2 (Month 1) | -1.890 episodes | Standard Deviation 1.5967 |
| Fesoterodine 4 mg | Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Visit 3 (Month 2) | -2.736 episodes | Standard Deviation 1.9249 |
| Fesoterodine 4 mg | Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Visit 4 (Month 3 or ET) | -3.127 episodes | Standard Deviation 2.021 |
| Fesoterodine 8 mg | Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Visit 4 (Month 3 or ET) | -2.636 episodes | Standard Deviation 1.7221 |
| Fesoterodine 8 mg | Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Baseline | 4.697 episodes | Standard Deviation 1.9914 |
| Fesoterodine 8 mg | Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Visit 3 (Month 2) | -2.182 episodes | Standard Deviation 1.4557 |
| Fesoterodine 8 mg | Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Visit 2 (Month 1) | -1.697 episodes | Standard Deviation 0.9827 |
| Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy | Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Visit 4 (Month 3 or ET) | -3.814 episodes | Standard Deviation 3.069 |
| Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy | Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Visit 2 (Month 1) | -1.650 episodes | Standard Deviation 1.3065 |
| Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy | Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Visit 3 (Month 2) | -2.895 episodes | Standard Deviation 2.6468 |
| Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy | Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Baseline | 5.587 episodes | Standard Deviation 3.7759 |
Primary
Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4
The mean number of UUI episodes: total number of UUI episodes, divided by the total diary days collected at that visit.
Time frame: Baseline, Month 1, Month 2, Month 3 or ET
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine 4 mg | Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Baseline | 2.601 episodes | Standard Deviation 1.7127 |
| Fesoterodine 4 mg | Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Visit 2 (Month 1) | -1.209 episodes | Standard Deviation 1.0891 |
| Fesoterodine 4 mg | Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Visit 3 (Month 2) | -1.806 episodes | Standard Deviation 1.3107 |
| Fesoterodine 4 mg | Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Visit 4 (Month 3 or ET) | -2.065 episodes | Standard Deviation 1.4582 |
| Fesoterodine 8 mg | Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Visit 4 (Month 3 or ET) | -1.733 episodes | Standard Deviation 1.6836 |
| Fesoterodine 8 mg | Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Baseline | 2.933 episodes | Standard Deviation 1.2551 |
| Fesoterodine 8 mg | Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Visit 3 (Month 2) | -1.583 episodes | Standard Deviation 1.4974 |
| Fesoterodine 8 mg | Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Visit 2 (Month 1) | -1.067 episodes | Standard Deviation 1.1738 |
| Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy | Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Visit 4 (Month 3 or ET) | -2.362 episodes | Standard Deviation 1.6477 |
| Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy | Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Visit 2 (Month 1) | -1.190 episodes | Standard Deviation 1.2532 |
| Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy | Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Visit 3 (Month 2) | -1.781 episodes | Standard Deviation 1.4729 |
| Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy | Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4 | Baseline | 3.467 episodes | Standard Deviation 2.4484 |
Secondary
Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4
The PVR urine volume: measured by an ultrasound scan.
Time frame: Baseline, Month 1, Month 2, Month 3 or ET
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine 4 mg | Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4 | Visit 2 (Month 1) | -6.650 ml | Standard Deviation 16.4784 |
| Fesoterodine 4 mg | Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4 | Visit 3 (Month 2) | -9.864 ml | Standard Deviation 20.2348 |
| Fesoterodine 4 mg | Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4 | Baseline | 27.932 ml | Standard Deviation 27.6079 |
| Fesoterodine 4 mg | Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4 | Visit 4 (Month 3 or ET) | -12.800 ml | Standard Deviation 23.9575 |
| Fesoterodine 8 mg | Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4 | Visit 2 (Month 1) | -12.800 ml | Standard Deviation 13.2313 |
| Fesoterodine 8 mg | Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4 | Baseline | 42.000 ml | Standard Deviation 35.6059 |
| Fesoterodine 8 mg | Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4 | Visit 3 (Month 2) | -18.700 ml | Standard Deviation 22.2663 |
| Fesoterodine 8 mg | Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4 | Visit 4 (Month 3 or ET) | -21.000 ml | Standard Deviation 24.3584 |
| Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy | Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4 | Visit 3 (Month 2) | -5.791 ml | Standard Deviation 17.8493 |
| Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy | Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4 | Baseline | 24.867 ml | Standard Deviation 27.7108 |
| Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy | Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4 | Visit 2 (Month 1) | -2.364 ml | Standard Deviation 11.25 |
| Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy | Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4 | Visit 4 (Month 3 or ET) | -7.415 ml | Standard Deviation 21.7658 |
Secondary
Change From Baseline in Total Scores of OAB-q at Visit 4
Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=\[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range\] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity.
Time frame: Baseline, Month 3 or ET
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fesoterodine 4 mg | Change From Baseline in Total Scores of OAB-q at Visit 4 | -34.101 scores on a scale | Standard Deviation 16.0799 |
| Fesoterodine 8 mg | Change From Baseline in Total Scores of OAB-q at Visit 4 | -34.318 scores on a scale | Standard Deviation 9.4928 |
| Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy | Change From Baseline in Total Scores of OAB-q at Visit 4 | -32.018 scores on a scale | Standard Deviation 17.7183 |
Secondary
Clinical Global Evaluation of Fesoterodine
Clinical global evaluation of study medication was assessed via the question 'how would you rate the study medication the patient received for overactive bladder?,' and was assessed on the four point categorical scale, ranging from 'Poor' to 'Excellent.'
Time frame: 12 weeks
Population: SAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fesoterodine 4 mg | Clinical Global Evaluation of Fesoterodine | Excellent | 513 participants |
| Fesoterodine 4 mg | Clinical Global Evaluation of Fesoterodine | Good | 274 participants |
| Fesoterodine 4 mg | Clinical Global Evaluation of Fesoterodine | Fair | 24 participants |
| Fesoterodine 4 mg | Clinical Global Evaluation of Fesoterodine | Poor | 9 participants |
| Fesoterodine 4 mg | Clinical Global Evaluation of Fesoterodine | Missing | 3 participants |
Secondary
Efficacy and Tolerability Compared to Previous Medication (Overall Treatment Effect Scale) at Visit 4
Overall Treatment Effect Scale: 3 questions from which a numeric score was derived. If a subject answered '(2) About the same' to question 1 then a score of 0 was given. If a subject answered '(1) Worse' to question 1, then a score between -7=a very great deal worse to -1=Almost the same, hardly worse at all was given depending on severity of their symptoms (determined from answer to question 2). If a subject answered '(3) Better' to question 1, then a score ranging from 1=Almost the same, hardly better at all to 7=A very great deal better, depending on their answer to question 3, was given.
Time frame: Month 3 or ET
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fesoterodine 4 mg | Efficacy and Tolerability Compared to Previous Medication (Overall Treatment Effect Scale) at Visit 4 | 5.661 scores on a scale | Standard Deviation 1.1663 |
| Fesoterodine 8 mg | Efficacy and Tolerability Compared to Previous Medication (Overall Treatment Effect Scale) at Visit 4 | 5.818 scores on a scale | Standard Deviation 0.9816 |
| Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy | Efficacy and Tolerability Compared to Previous Medication (Overall Treatment Effect Scale) at Visit 4 | 4.702 scores on a scale | Standard Deviation 1.7925 |
Secondary
Overactive Bladder Questionnaire (OAB-q): Symptom Severity/Bother Scale
Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=\[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range\] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity.
Time frame: Baseline, Month 3 or ET
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine 4 mg | Overactive Bladder Questionnaire (OAB-q): Symptom Severity/Bother Scale | Baseline | 59.263 scores on a scale | Standard Deviation 17.5239 |
| Fesoterodine 4 mg | Overactive Bladder Questionnaire (OAB-q): Symptom Severity/Bother Scale | Visit 4 (Month 3 or ET) | 25.147 scores on a scale | Standard Deviation 14.369 |
| Fesoterodine 8 mg | Overactive Bladder Questionnaire (OAB-q): Symptom Severity/Bother Scale | Visit 4 (Month 3 or ET) | 35.682 scores on a scale | Standard Deviation 12.752 |
| Fesoterodine 8 mg | Overactive Bladder Questionnaire (OAB-q): Symptom Severity/Bother Scale | Baseline | 70.000 scores on a scale | Standard Deviation 10.1242 |
| Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy | Overactive Bladder Questionnaire (OAB-q): Symptom Severity/Bother Scale | Baseline | 64.737 scores on a scale | Standard Deviation 17.1696 |
| Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy | Overactive Bladder Questionnaire (OAB-q): Symptom Severity/Bother Scale | Visit 4 (Month 3 or ET) | 32.719 scores on a scale | Standard Deviation 17.9115 |
Secondary
Patient's Global Evaluation of Fesoterodine
The patients global evaluation of study medication was assessed via the question 'how would you rate your overall response to the study medication?' and was assessed on the four point categorical scale, ranging from 'Poor' to 'Excellent'.
Time frame: Baseline, Month 3 or ET
Population: The safety analysis set (SAS) included all subjects who enrolled in the study, signed informed consent and received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fesoterodine 4 mg | Patient's Global Evaluation of Fesoterodine | Excellent | 536 participants |
| Fesoterodine 4 mg | Patient's Global Evaluation of Fesoterodine | Good | 252 participants |
| Fesoterodine 4 mg | Patient's Global Evaluation of Fesoterodine | Fair | 22 participants |
| Fesoterodine 4 mg | Patient's Global Evaluation of Fesoterodine | Poor | 10 participants |
| Fesoterodine 4 mg | Patient's Global Evaluation of Fesoterodine | Missing | 3 participants |
Secondary
Reasons for Study Treatment Dose Changes
Possible change in the dose and the reasons for the change were collected and documented.
Time frame: Month 3 or ET
Population: SAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fesoterodine 4 mg | Reasons for Study Treatment Dose Changes | Inefectivity, Not Sufficient Effectivity | 22 participants |
| Fesoterodine 4 mg | Reasons for Study Treatment Dose Changes | Infectivity | 29 participants |
| Fesoterodine 4 mg | Reasons for Study Treatment Dose Changes | Insufficient (efficiency) effect | 1 participants |
| Fesoterodine 4 mg | Reasons for Study Treatment Dose Changes | Insufficient response | 1 participants |
| Fesoterodine 4 mg | Reasons for Study Treatment Dose Changes | Poor overall response | 1 participants |
| Fesoterodine 4 mg | Reasons for Study Treatment Dose Changes | Missing | 4 participants |
Secondary
Study Doses
Number of subjects that changed doses throughout the study period.
Time frame: Month 3 or ET
Population: SAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fesoterodine 4 mg | Study Doses | Increased | 57 participants |
| Fesoterodine 4 mg | Study Doses | Stayed the same | 766 participants |
| Fesoterodine 4 mg | Study Doses | Decreased | 0 participants |
| Fesoterodine 4 mg | Study Doses | Fluctuated | 0 participants |
Secondary
Time To Onset Of Treatment Response
Participant's perception of treatment response assessment since the previous visit was noted at each visit. Time to onset of response was calculated in weeks from start of treatment.
Time frame: Month 1, Month 2, Month 3 or ET
Population: FAS
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Fesoterodine 4 mg | Time To Onset Of Treatment Response | 3.0 weeks | Full Range 1.27 |
| Fesoterodine 8 mg | Time To Onset Of Treatment Response | 3.0 weeks | Full Range 1.1 |
| Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy | Time To Onset Of Treatment Response | 3.0 weeks | Full Range 2.72 |