An observational study in Overactive Bladder (OAB), sponsored by Pfizer. Completed. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-06-11.
Sponsored by Pfizer · Observational
The purpose of this study is to collect effectiveness and safety information of fesoterodine related to their appropriate use in daily practice.
864 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.
This study's enrollment of 2,521 is above the median of 109 across 167 observational studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.
Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients prescribed fesoterodine (Toviaz) by investigators involved in protocol A0221096.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Drug: Fesoterodine (Toviaz)
Fesoterodine 4 mg or 8 mg orally. Toviaz will be dosed according to labeling. The administration and duration of therapy will be determined by the treating physician to meet the patient's needs for treatment.
Number of Participants With Treatment-Related Adverse Events
A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Relatedness to fesoterodine fumarate was assessed by the investigator.
Time frame: 12 Weeks
Clinical Efficacy Rate
Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Overall effectiveness of fesoterodine fumarate was determined by the investigator based on clinical symptoms and examinations. Clinical effectiveness was assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable at week 12 of the treatment.
Time frame: 12 Weeks
Number of Participants With Treatment-Related Serious Adverse Events
A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to fesoterodine fumarate was assessed by the investigator.
Time frame: 12 Weeks
Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to fesoterodine fumarate was assessed by the investigator.
Time frame: 12 Weeks
Number of Participants With Adverse Events Related to Cognitive Function Disorder
An adverse event was any untoward medical occurrence in a participant who received fesoterodine fumarate without regard to possibility of causal relationship. Adverse events related to cognitive function disorder were identified by broad searches on the Standard MedDRA Queries (SMQ).
Time frame: 12 Weeks
Change From Baseline in the Mini-Mental State Examination (MMSE) Score at 12 Weeks
Mini-Mental State Examination (MMSE) measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state. Mean change from baseline in the MMSE score at 12 weeks was presented along with the corresponding standard deviation.
Time frame: Baseline, 12 Weeks
Number of Participants With Treatment-Related Adverse Events Among Whom Received Concomitant CYP3A4 Inhibitors
Cytochrome P450 3A4 (CYP3A4) inhibitors included atazanavir, clarithromycin, indinavir, itraconazole, nelfinavir, ritonavir, saquinavir, and telithromycin.
Time frame: 12 Weeks
Number of Participants With Treatment-Related Adverse Events Among Whom Received Concomitant CYP2D6 Inhibitors
Cytochrome P450 2D6 (CYP2D6) inhibitors included quinidine and paroxetine. A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Relatedness to fesoterodine fumarate was assessed by the investigator.
Time frame: 12 Weeks
Number of Participants With Treatment-Related Adverse Events Among Whose Dose Was Increased From 4 mg to 8 mg
A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Relatedness to fesoterodine fumarate was assessed by the investigator.
Time frame: 12 Weeks
Satisfaction Rate
Satisfaction rate, which was defined as the percentage of participants who were satisfied by fesoterodine fumarate treatment over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Satisfaction scale was assessed by the participants according to the following categories: (1) satisfied, (2) unsatisfied, (3) uncertain, or (4) unconfirmed.
Time frame: 12 Weeks
Change From Baseline in the Overactive Bladder Symptom Score (OABSS) at 12 Weeks
Overactive Bladder Symptom Score (OABSS) was defined as the sum score (0 to 15) of the following four OAB symptoms: daytime frequency (2 at maximum), nighttime frequency (3 at maximum), urgency (5 at maximum), and urgency incontinence (5 at maximum). Higher score indicates worse symptoms. Mean change from baseline in the OABSS at 12 weeks was presented along with the corresponding standard deviation.
Time frame: Baseline, 12 Weeks
| Milestone | Fesoterodine Fumarate |
|---|---|
| Started | 2492 |
| Completed | 2303 |
| Not completed | 189 |
| Withdrew: No visit after treatment | 176 |
| Withdrew: Protocol violation | 12 |
| Withdrew: No drug administration | 1 |
A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Relatedness to fesoterodine fumarate was assessed by the investigator.
| Participants | Fesoterodine Fumarate |
|---|---|
| Number of Participants With Treatment-Related Adverse Events | 415 |
Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Overall effectiveness of fesoterodine fumarate was determined by the investigator based on clinical symptoms and examinations. Clinical effectiveness was assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable at week 12 of the treatment.
| Percentage of participants | Fesoterodine Fumarate |
|---|---|
| Clinical Efficacy Rate | 74.8 (73.0 to 76.5) |
A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to fesoterodine fumarate was assessed by the investigator.
| Participants | Fesoterodine Fumarate |
|---|---|
| Number of Participants With Treatment-Related Serious Adverse Events | 8 |
A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to fesoterodine fumarate was assessed by the investigator.
| Participants | Fesoterodine Fumarate |
|---|---|
| Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | 27 |
An adverse event was any untoward medical occurrence in a participant who received fesoterodine fumarate without regard to possibility of causal relationship. Adverse events related to cognitive function disorder were identified by broad searches on the Standard MedDRA Queries (SMQ).
| Participants | Fesoterodine Fumarate |
|---|---|
| Number of Participants With Adverse Events Related to Cognitive Function Disorder | 2 |
Mini-Mental State Examination (MMSE) measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state. Mean change from baseline in the MMSE score at 12 weeks was presented along with the corresponding standard deviation.
| Scale | Fesoterodine Fumarate |
|---|---|
| Change From Baseline in the Mini-Mental State Examination (MMSE) Score at 12 Weeks | 0.4 ± 1.29 |
Cytochrome P450 3A4 (CYP3A4) inhibitors included atazanavir, clarithromycin, indinavir, itraconazole, nelfinavir, ritonavir, saquinavir, and telithromycin.
| Participants | Fesoterodine Fumarate |
|---|---|
| Received Concomitant CYP3A4 Inhibitors | 6 |
| Not Received Concomitant CYP3A4 Inhibitors | 409 |
Cytochrome P450 2D6 (CYP2D6) inhibitors included quinidine and paroxetine. A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Relatedness to fesoterodine fumarate was assessed by the investigator.
| Participants | Fesoterodine Fumarate |
|---|---|
| Received Concomitant CYP2D6 Inhibitors | 11 |
| Not Received Concomitant CYP2D6 Inhibitors | 404 |
A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Relatedness to fesoterodine fumarate was assessed by the investigator.
| Participants | Fesoterodine Fumarate |
|---|---|
| From 4 mg to 8 mg | 53 |
| 4 mg | 330 |
| 8 mg | 32 |
Satisfaction rate, which was defined as the percentage of participants who were satisfied by fesoterodine fumarate treatment over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Satisfaction scale was assessed by the participants according to the following categories: (1) satisfied, (2) unsatisfied, (3) uncertain, or (4) unconfirmed.
| Percentage of participants | Fesoterodine Fumarate |
|---|---|
| Satisfaction Rate | 59.0 (57.0 to 61.0) |
Overactive Bladder Symptom Score (OABSS) was defined as the sum score (0 to 15) of the following four OAB symptoms: daytime frequency (2 at maximum), nighttime frequency (3 at maximum), urgency (5 at maximum), and urgency incontinence (5 at maximum). Higher score indicates worse symptoms. Mean change from baseline in the OABSS at 12 weeks was presented along with the corresponding standard deviation.
| Scale | Fesoterodine Fumarate |
|---|---|
| Change From Baseline in the Overactive Bladder Symptom Score (OABSS) at 12 Weeks | -3.4 ± 3.04 |
Non-serious events are listed at a 1.0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fesoterodine Fumarate | — | 12/2,303 (0.5%) | 361/2,303 (15.7%) |
| Event | Fesoterodine Fumarate |
|---|---|
| Urinary retentionRenal and urinary disorders | 3/2303 |
| PneumoniaInfections and infestations | 1/2303 |
| Loss of consciousnessNervous system disorders | 1/2303 |
| Cerebral infarctionNervous system disorders | 1/2303 |
| Respiratory arrestRespiratory, thoracic and mediastinal disorders | 1/2303 |
| Pneumonia aspirationRespiratory, thoracic and mediastinal disorders | 1/2303 |
| Acute abdomenGastrointestinal disorders | 1/2303 |
| ConstipationGastrointestinal disorders | 1/2303 |
| Cholecystitis acuteHepatobiliary disorders | 1/2303 |
| DysuriaRenal and urinary disorders | 1/2303 |
| Event | Fesoterodine Fumarate |
|---|---|
| ThirstGeneral disorders | 166/2303 |
| ConstipationGastrointestinal disorders | 72/2303 |
| DysuriaRenal and urinary disorders | 63/2303 |
| Dry mouthGastrointestinal disorders | 36/2303 |
| Urinary retentionRenal and urinary disorders | 24/2303 |
A total of 2492 participants completed this study. Of the 2492 participants, 189 participants were excluded from the baseline analysis due to following reasons: no visit after treatment (176 participants), protocol violation (12 participants), and no drug administration (1 participant).
| Age, Customized(Participants) | Fesoterodine Fumarate |
|---|---|
| <15 years | 1 |
| >=15 and <65 years | 529 |
| ˃=65 years | 1773 |
| Sex: Female, Male(Participants) | Fesoterodine Fumarate |
|---|---|
| Female | 1228 |
| Male | 1075 |
No study locations are listed for this record.
Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Ran from Oct 2013 to primary completion in May 2016, 31 months.
Results were first posted in Apr 2017, 10 months after primary completion.
Of 56 observational studies under Urinary Bladder, Overactive, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 53. This study's 31 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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