Over Active Bladder
Conditions
Keywords
Observational
Brief summary
This is an observational study and will determine the safety profile of fesoterodine in Filipino patients prescribed the drug. This is in compliance with the requirements of the Philippine Food and Drug Administration.
Detailed description
Sampling method is not applicable in this study. Only patients prescribed Fesoterodine will be enrolled.
Interventions
DRUGFesoterodine
Any dose of Fesoterodine
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Over-active bladder * Prescribed with Fesoterodine
Exclusion criteria
* Hypersensitivity * Urinary retention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment | Baseline up to 28 days after last dose | Counts of participants who had treatment-emergent AEs (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to fesoterodine fumarate (Toviaz) was assessed by the investigator. Participants with multiple occurrences of an AE within a category were counted once within the category. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to AE) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to AE). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Micturitions Per 24 Hours at Week 4 and Week 8 | Week 4 and Week 8 | Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with Urinary Sensation Scale (USS) rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine. |
| Number of Urgency Episodes Per 24 Hours at Week 4 and Week 8 | Week 4 and Week 8 | Urgency episodes were defined as micturitions with USS rating of greater than or equal to (\>=) 3. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. |
| Number of UUI Episodes Per 24 Hours at Week 4 and Week 8 | Week 4 and Week 8 | UUI episodes were defined as those with USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. |
| Patient Perception of Bladder Condition (PPBC) at Week 4 and Week 8 | Week 4 and Week 8 | PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Improvement is defined as negative change from baseline. |
Countries
Philippines
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fesoterodine Fumarate Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity. | 508 |
| Total | 508 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 11 |
| Overall Study | Fesoterodine Started Before Enrollment | 1 |
| Overall Study | Financial Constraints | 77 |
| Overall Study | Gone to Province | 2 |
| Overall Study | Lack of Efficacy | 4 |
| Overall Study | Lost to Follow-up | 25 |
| Overall Study | Medication Stopped | 1 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Fesoterodine Fumarate |
|---|---|
| Age, Continuous | 54.5 years STANDARD_DEVIATION 15 |
| Body Mass Index | 24.1 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 4.1 |
| Height | 163.2 centimeter (cm) STANDARD_DEVIATION 10.1 |
| Sex: Female, Male Female | 199 Participants |
| Sex: Female, Male Male | 309 Participants |
| Weight | 64.1 kilogram (kg) STANDARD_DEVIATION 11.4 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 21 / 508 |
| serious Total, serious adverse events | 0 / 508 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment
Counts of participants who had treatment-emergent AEs (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to fesoterodine fumarate (Toviaz) was assessed by the investigator. Participants with multiple occurrences of an AE within a category were counted once within the category. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to AE) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to AE).
Time frame: Baseline up to 28 days after last dose
Population: Safety population defined as all participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fesoterodine Fumarate | Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment | Participants with AEs, all-causality | 21 participants |
| Fesoterodine Fumarate | Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment | Participants with AEs, treatment-related | 19 participants |
| Fesoterodine Fumarate | Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment | Participants with serious AEs, all-causality | 0 participants |
| Fesoterodine Fumarate | Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment | Participants with serious AEs, treatment-related | 0 participants |
| Fesoterodine Fumarate | Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment | Participants with severe AEs, all-causality | 2 participants |
| Fesoterodine Fumarate | Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment | Participants with severe AEs, treatment-related | 2 participants |
Other Pre-specified
Number of Micturitions Per 24 Hours at Week 4 and Week 8
Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with Urinary Sensation Scale (USS) rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.
Time frame: Week 4 and Week 8
Population: This efficacy outcome measure was removed in Protocol Amendment 1 and thus data was not collected.
Other Pre-specified
Number of Urgency Episodes Per 24 Hours at Week 4 and Week 8
Urgency episodes were defined as micturitions with USS rating of greater than or equal to (\>=) 3. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Time frame: Week 4 and Week 8
Population: This efficacy outcome measure was removed in Protocol Amendment 1 and thus data was not collected.
Other Pre-specified
Number of UUI Episodes Per 24 Hours at Week 4 and Week 8
UUI episodes were defined as those with USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Time frame: Week 4 and Week 8
Population: This efficacy outcome measure was removed in Protocol Amendment 1 and thus data was not collected.
Other Pre-specified
Patient Perception of Bladder Condition (PPBC) at Week 4 and Week 8
PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Improvement is defined as negative change from baseline.
Time frame: Week 4 and Week 8
Population: This efficacy outcome measure was removed in Protocol Amendment 1 and thus data was not collected.