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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.
patients older than 18 years with overactive bladder after failure of previous antimuscarinic therapy (due to lack of efficacy or intolerance)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fesoterodine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fesoterodine | Drug | 4 mg per 24 hours, possibility to increase to 8 mg depending on efficacy chronic treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Month 1, Month 2, Month 3 or Early Termination (ET) |
| 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. | Baseline, Month 1, Month 2, Month 3 or ET |
| 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). | Baseline, Month 1, Month 2, Month 3 or ET |
| 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. | Baseline, Month 1, Month 2, Month 3 or ET |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Month 1, Month 2, Month 3 or ET |
| Patient's Global Evaluation of Fesoterodine |
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Inclusion Criteria:
Exclusion Criteria:
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patients older than 18 years with overactive bladder after failure of previous antimuscarinic therapy (due to lack of efficacy or intolerance)
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | ?a?a | Slovakia | ||||
| Pfizer Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fesoterodine 4 mg or 8 mg | The recommended starting dose was 4 mg once daily. Based upon individual response, the dose was increased to 8 mg once daily. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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'.
| Baseline, Month 3 or ET |
| 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.' | 12 weeks |
| 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. | Month 3 or ET |
| 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. | Baseline, Month 3 or ET |
| 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. | Baseline, Month 3 or ET |
| 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. | Month 1, Month 2, Month 3 or ET |
| Study Doses | Number of subjects that changed doses throughout the study period. | Month 3 or ET |
| Reasons for Study Treatment Dose Changes | Possible change in the dose and the reasons for the change were collected and documented. | Month 3 or ET |
| Aa |
| Slovakia |
| Pfizer Investigational Site | Adca | Slovakia |
| Pfizer Investigational Site | B.Bystrica | Slovakia |
| Pfizer Investigational Site | Banská Bystrica | 974 01 | Slovakia |
| Pfizer Investigational Site | Bardejov | Slovakia |
| Pfizer Investigational Site | Bratislava | 82109 | Slovakia |
| Pfizer Investigational Site | Bratislava | 82606 | Slovakia |
| Pfizer Investigational Site | Bratislava | 833 05 | Slovakia |
| Pfizer Investigational Site | Bratislava | 851 01 | Slovakia |
| Pfizer Investigational Site | Bratislava | 851 05 | Slovakia |
| Pfizer Investigational Site | Bratislava | 85104 | Slovakia |
| Pfizer Investigational Site | Bratislava | 85107 | Slovakia |
| Pfizer Investigational Site | Bratislava | Slovakia |
| Pfizer Investigational Site | Dolný Kubín | Slovakia |
| Pfizer Investigational Site | Dunajská Streda | Slovakia |
| Pfizer Investigational Site | Hlohovec | Slovakia |
| Pfizer Investigational Site | Humenné | Slovakia |
| Pfizer Investigational Site | Ilina | Slovakia |
| Pfizer Investigational Site | Koice-aca | Slovakia |
| Pfizer Investigational Site | Koice | Slovakia |
| Pfizer Investigational Site | Komárno | Slovakia |
| Pfizer Investigational Site | Košice | 041 90 | Slovakia |
| Pfizer Investigational Site | Košice | Slovakia |
| Pfizer Investigational Site | Kraovsky Chlmec | Slovakia |
| Pfizer Investigational Site | Liptovský Hrádok | Slovakia |
| Pfizer Investigational Site | Liptovský Mikuláš | Slovakia |
| Pfizer Investigational Site | Luenec | Slovakia |
| Pfizer Investigational Site | Malacky | 901 01 | Slovakia |
| Pfizer Investigational Site | Malacky | 90122 | Slovakia |
| Pfizer Investigational Site | Martin | Slovakia |
| Pfizer Investigational Site | Michalovce | Slovakia |
| Pfizer Investigational Site | Myjava | Slovakia |
| Pfizer Investigational Site | Námestovo | Slovakia |
| Pfizer Investigational Site | Nitra | 949 01 | Slovakia |
| Pfizer Investigational Site | Nitra | 951 01 | Slovakia |
| Pfizer Investigational Site | Nitra | Slovakia |
| Pfizer Investigational Site | Nové Zámky | Slovakia |
| Pfizer Investigational Site | Piešťany | 921 01 | Slovakia |
| Pfizer Investigational Site | Poprad | Slovakia |
| Pfizer Investigational Site | Povaska Bystrica | Slovakia |
| Pfizer Investigational Site | Považská Bystrica | 017 01 | Slovakia |
| Pfizer Investigational Site | Preov | Slovakia |
| Pfizer Investigational Site | Prievidza | Slovakia |
| Pfizer Investigational Site | Púchov | Slovakia |
| Pfizer Investigational Site | Revúca | Slovakia |
| Pfizer Investigational Site | Rimavská Sobota | Slovakia |
| Pfizer Investigational Site | Ruomberok | Slovakia |
| Pfizer Investigational Site | Ružomberok | Slovakia |
| Pfizer Investigational Site | Senica | 90501 | Slovakia |
| Pfizer Investigational Site | Skalica | 90901 | Slovakia |
| Pfizer Investigational Site | Sobrance | Slovakia |
| Pfizer Investigational Site | SpisskaNova Ves | Slovakia |
| Pfizer Investigational Site | Stropkov | Slovakia |
| Pfizer Investigational Site | Svidník | Slovakia |
| Pfizer Investigational Site | Topoany | Slovakia |
| Pfizer Investigational Site | Trebišov | Slovakia |
| Pfizer Investigational Site | Trenčín | 911 01 | Slovakia |
| Pfizer Investigational Site | Trenin | Slovakia |
| Pfizer Investigational Site | Trnava | Slovakia |
| Pfizer Investigational Site | Turianske Teplice | Slovakia |
| Pfizer Investigational Site | Urany | Slovakia |
| Pfizer Investigational Site | Vranov n/Topou | Slovakia |
| Pfizer Investigational Site | Vráble | Slovakia |
| Pfizer Investigational Site | Zvolen | Slovakia |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | episodes | Baseline, Month 1, Month 2, Month 3 or Early Termination (ET) |
|
|
| ||||||||||||||||||||||||||||||||
| 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. | FAS | Posted | Mean | Standard Deviation | ml | Baseline, Month 1, Month 2, Month 3 or ET |
|
| |||||||||||||||||||||||||||||||||
| 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'. | 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. | Posted | Number | participants | Baseline, Month 3 or ET |
|
| ||||||||||||||||||||||||||||||||||
| 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.' | SAS | Posted | Number | participants | 12 weeks |
|
| ||||||||||||||||||||||||||||||||||
| 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. | FAS | Posted | Mean | Standard Deviation | scores on a scale | Month 3 or ET |
|
| |||||||||||||||||||||||||||||||||
| 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. | FAS | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Month 3 or ET |
|
| |||||||||||||||||||||||||||||||||
| 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. | FAS | Posted | Mean | Standard Deviation | episodes | Baseline, Month 1, Month 2, Month 3 or ET |
|
| |||||||||||||||||||||||||||||||||
| 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). | FAS | Posted | Mean | Standard Deviation | episodes | Baseline, Month 1, Month 2, Month 3 or ET |
|
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| 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. | FAS | Posted | Mean | Standard Deviation | episodes | Baseline, Month 1, Month 2, Month 3 or ET |
|
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| 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. | FAS | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Month 3 or ET |
|
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| 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. | FAS | Posted | Median | Full Range | weeks | Month 1, Month 2, Month 3 or ET |
|
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| Secondary | Study Doses | Number of subjects that changed doses throughout the study period. | SAS | Posted | Number | participants | Month 3 or ET |
|
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| |||||||||||||||||||||||||||||||||
| Secondary | Reasons for Study Treatment Dose Changes | Possible change in the dose and the reasons for the change were collected and documented. | SAS | Posted | Number | participants | Month 3 or ET |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fesoterodine 4 mg or 8 mg | All Subjects | 0 | 823 | 78 | 823 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Adverse event | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014555 | Urination Disorders |
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| ID | Term |
|---|---|
| C526675 | fesoterodine |
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| Title | Measurements |
|---|
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| >=65 years |
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| Visit 3 (Month 2) |
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| Visit 4 (Month 3 or ET) |
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| Increased |
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| Stayed the same |
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| Decreased |
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| Fluctuated |
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| Inefectivity, Not Sufficient Effectivity |
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| Infectivity |
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| Insufficient (efficiency) effect |
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| Insufficient response |
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| Poor overall response |
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| Missing |
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