Overactive Bladder
Conditions
Keywords
Overactive Bladder, Japanese, Tolterodine, Detrusitol, Detrol, Postmarketing commitment plan.
Brief summary
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the Package Insert (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug.
Detailed description
All the subjects whom an investigator prescribes the first Detrusitol Capsule should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Interventions
Detrusitol Capsule 2mg and 4mg, depending on the Investigator prescription.Frequency and duration are according to Package Insert as follows.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Male or female subjects intend to treat their overactive bladder who are prescribed Detrusitol Capsule by their physicians.
Exclusion criteria
* Subjects who have been prescribed Detrusitol Capsule before.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs). | 12 weeks | All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. |
| Number of Participants Which Was Evaluated as Degree of Satisfaction. | 12 week | Participant satisfaction was evaluated by investigators based on questioning the participants at the end of observation period using choices: Satisfied, Dissatisfied, Neither of the above. |
| Number of Participants With an Investigator's Assessment of Clinical Outcome at End of the Study. | 12 week | Clinical overall effectiveness was evaluated by investigators based on clinical symptoms, etc, at the end of observation period. |
| Confirmation of Frequent Treatment Related Adverse Events (TRAEs) at the End of Observation Period. | 12 week | The Treatment Related Adverse Events (TRAEs) at the end of observation period with an incidence of 1% or higher. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk Factors for the Proportion of Responders of Tolterodine-Age | 12 week | Number of participants with responders of tolterodine to determine whether \<65 years or \>=65 years is significant risk factor. |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Tolterodine - Comorbidity of Prostatic Hypertrophy | 12 week | Number of participants with Treatment Related Adverse Events (TRAEs) of tolterodine to determine whether with or without comorbidity of benign prostatic hypertrophy (BPH) is significant risk factor. |
| Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants | 12 week | All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert. |
| Risk Factors for the Proportion of Responders of Tolterodine-Severity of Overactive Bladder | 12 week | Number of participants with responders of tolterodine to determine whether mild, moderate or severe is significant risk factor. |
| Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs | 12 week | Number of participants with responders of tolterodine to determine whether with or without concomitant drugs is significant risk factor. |
| Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinations Per Day (During Sleep) | 12 week | Number of participants with responders of tolterodine to determine the Number of urinations per day (during sleep) is significant risk factor. |
| Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinary Incontinence Episodes Per Day | 12 week | Number of participants with responders of tolterodine to determine the Number of urinary incontinence episodes per day is significant risk factor. |
| Risk Factors for the Proportion of Responders of Tolterodine-Previous Treatment | 12 week | Number of participants with response to tolterodine to determine whether with or without previous treatment is significant risk factor. |
| Risk Factors for the Proportion of Responders of Tolterodine-Urinary Urgency | 12 week | Number of participants with responders of tolterodine to determine whether with or without Urinary urgency is significant risk factor. |
| Risk Factors for the Proportion of Responders of Tolterodine-Non-drug Therapies | 12 week | Number of participants with responders of tolterodine to determine whether with or without Non-drug therapies is significant risk factor. |
| Risk Factors for the Proportion of Responders of Tolterodine-Gender | 12 week | Number of participants with responders of tolterodine to determine whether male or female is significant risk factor. |
| Risk Factors for the Proportion of Responders of Tolterodine-Complications | 12 week | Number of participants with responders of tolterodine to determine whether with or without complications is significant risk factor. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tolterodine Tartrate Participants taking Tolterodine tartrate according to Japanese Package Insert. | 9,321 |
| Total | 9,321 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1,836 |
Baseline characteristics
| Characteristic | Tolterodine Tartrate |
|---|---|
| Age, Customized <65 years | 2848 participants |
| Age, Customized >=65 years | 6473 participants |
| Complications Absent | 3484 participants |
| Complications Present | 5837 participants |
| Concomitant drug Absent | 4246 participants |
| Concomitant drug Present | 5057 participants |
| Sex: Female, Male Female | 5263 Participants |
| Sex: Female, Male Male | 4058 Participants |
| Starting dose 2 mg | 1813 participants |
| Starting dose 4 mg | 7506 participants |
| Starting dose 8 mg | 2 participants |
| Target disease severity Mild | 3530 participants |
| Target disease severity Moderate | 5185 participants |
| Target disease severity Severe | 606 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 703 / 9,321 |
| serious Total, serious adverse events | 12 / 9,321 |
Outcome results
Primary
Confirmation of Frequent Treatment Related Adverse Events (TRAEs) at the End of Observation Period.
The Treatment Related Adverse Events (TRAEs) at the end of observation period with an incidence of 1% or higher.
Time frame: 12 week
Population: Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of Detrusitol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tolterodine Tartrate | Confirmation of Frequent Treatment Related Adverse Events (TRAEs) at the End of Observation Period. | Thirst | 344 events |
| Tolterodine Tartrate | Confirmation of Frequent Treatment Related Adverse Events (TRAEs) at the End of Observation Period. | Constipation | 194 events |
| Tolterodine Tartrate | Confirmation of Frequent Treatment Related Adverse Events (TRAEs) at the End of Observation Period. | Dysuria | 166 events |
Primary
Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs).
All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.
Time frame: 12 weeks
Population: Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of Detrusitol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tolterodine Tartrate | Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs). | 984 participants |
Primary
Number of Participants Which Was Evaluated as Degree of Satisfaction.
Participant satisfaction was evaluated by investigators based on questioning the participants at the end of observation period using choices: Satisfied, Dissatisfied, Neither of the above.
Time frame: 12 week
Population: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tolterodine Tartrate | Number of Participants Which Was Evaluated as Degree of Satisfaction. | Satisfied | 5609 participants |
| Tolterodine Tartrate | Number of Participants Which Was Evaluated as Degree of Satisfaction. | Dissatisfied | 1033 participants |
| Tolterodine Tartrate | Number of Participants Which Was Evaluated as Degree of Satisfaction. | Neither of the above | 963 participants |
| Tolterodine Tartrate | Number of Participants Which Was Evaluated as Degree of Satisfaction. | Unknown | 175 participants |
Primary
Number of Participants With an Investigator's Assessment of Clinical Outcome at End of the Study.
Clinical overall effectiveness was evaluated by investigators based on clinical symptoms, etc, at the end of observation period.
Time frame: 12 week
Population: The efficacy analysis population included all subjects from the safety analysis population in whom the efficacy of this drug could be evaluated.~Number of participants evaluable for which was evaluated effect.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tolterodine Tartrate | Number of Participants With an Investigator's Assessment of Clinical Outcome at End of the Study. | Effective | 6536 participants |
| Tolterodine Tartrate | Number of Participants With an Investigator's Assessment of Clinical Outcome at End of the Study. | Not effective | 1244 participants |
Secondary
Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants
All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.
Time frame: 12 week
Population: Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of Detrusitol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tolterodine Tartrate | Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants | Abdominal discomfort | 18 events |
| Tolterodine Tartrate | Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants | Pollakiuria | 11 events |
| Tolterodine Tartrate | Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants | Cystitis | 10 events |
| Tolterodine Tartrate | Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants | Abdominal distension | 10 events |
| Tolterodine Tartrate | Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants | Pruritus | 6 events |
| Tolterodine Tartrate | Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants | Stomatitis | 5 events |
| Tolterodine Tartrate | Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants | Malaise | 5 events |
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Tolterodine - Comorbidity of Prostatic Hypertrophy
Number of participants with Treatment Related Adverse Events (TRAEs) of tolterodine to determine whether with or without comorbidity of benign prostatic hypertrophy (BPH) is significant risk factor.
Time frame: 12 week
Population: The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tolterodine Tartrate | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Tolterodine - Comorbidity of Prostatic Hypertrophy | 319 participants |
| Without Concomitant Drugs | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Tolterodine - Comorbidity of Prostatic Hypertrophy | 130 participants |
p-value: <0.001The Hosmer-Lemeshow Goodness-of-Fit TEST
Secondary
Risk Factors for the Proportion of Responders of Tolterodine-Age
Number of participants with responders of tolterodine to determine whether \<65 years or \>=65 years is significant risk factor.
Time frame: 12 week
Population: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tolterodine Tartrate | Risk Factors for the Proportion of Responders of Tolterodine-Age | 2060 participants |
| Without Concomitant Drugs | Risk Factors for the Proportion of Responders of Tolterodine-Age | 4476 participants |
p-value: <0.001Chi-squared
Secondary
Risk Factors for the Proportion of Responders of Tolterodine-Complications
Number of participants with responders of tolterodine to determine whether with or without complications is significant risk factor.
Time frame: 12 week
Population: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tolterodine Tartrate | Risk Factors for the Proportion of Responders of Tolterodine-Complications | 3960 participants |
| Without Concomitant Drugs | Risk Factors for the Proportion of Responders of Tolterodine-Complications | 2576 participants |
p-value: <0.001Chi-squared
Secondary
Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs
Number of participants with responders of tolterodine to determine whether with or without concomitant drugs is significant risk factor.
Time frame: 12 week
Population: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tolterodine Tartrate | Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs | 3483 participants |
| Without Concomitant Drugs | Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs | 3053 participants |
p-value: <0.001Chi-squared
Secondary
Risk Factors for the Proportion of Responders of Tolterodine-Gender
Number of participants with responders of tolterodine to determine whether male or female is significant risk factor.
Time frame: 12 week
Population: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tolterodine Tartrate | Risk Factors for the Proportion of Responders of Tolterodine-Gender | 2745 participants |
| Without Concomitant Drugs | Risk Factors for the Proportion of Responders of Tolterodine-Gender | 3791 participants |
p-value: <0.001Chi-squared
Secondary
Risk Factors for the Proportion of Responders of Tolterodine-Non-drug Therapies
Number of participants with responders of tolterodine to determine whether with or without Non-drug therapies is significant risk factor.
Time frame: 12 week
Population: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tolterodine Tartrate | Risk Factors for the Proportion of Responders of Tolterodine-Non-drug Therapies | 317 participants |
| Without Concomitant Drugs | Risk Factors for the Proportion of Responders of Tolterodine-Non-drug Therapies | 6219 participants |
p-value: =0.032Chi-squared
Secondary
Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinary Incontinence Episodes Per Day
Number of participants with responders of tolterodine to determine the Number of urinary incontinence episodes per day is significant risk factor.
Time frame: 12 week
Population: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tolterodine Tartrate | Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinary Incontinence Episodes Per Day | 1670 participants |
| Without Concomitant Drugs | Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinary Incontinence Episodes Per Day | 710 participants |
| Severe | Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinary Incontinence Episodes Per Day | 254 participants |
p-value: <0.001Chi-squared
Secondary
Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinations Per Day (During Sleep)
Number of participants with responders of tolterodine to determine the Number of urinations per day (during sleep) is significant risk factor.
Time frame: 12 week
Population: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tolterodine Tartrate | Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinations Per Day (During Sleep) | 370 participants |
| Without Concomitant Drugs | Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinations Per Day (During Sleep) | 882 participants |
| Severe | Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinations Per Day (During Sleep) | 1380 participants |
| >= 3 Urinations | Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinations Per Day (During Sleep) | 3523 participants |
p-value: =0.015Chi-squared
Secondary
Risk Factors for the Proportion of Responders of Tolterodine-Previous Treatment
Number of participants with response to tolterodine to determine whether with or without previous treatment is significant risk factor.
Time frame: 12 week
Population: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tolterodine Tartrate | Risk Factors for the Proportion of Responders of Tolterodine-Previous Treatment | 698 participants |
| Without Concomitant Drugs | Risk Factors for the Proportion of Responders of Tolterodine-Previous Treatment | 5753 participants |
p-value: <0.001Chi-squared
Secondary
Risk Factors for the Proportion of Responders of Tolterodine-Severity of Overactive Bladder
Number of participants with responders of tolterodine to determine whether mild, moderate or severe is significant risk factor.
Time frame: 12 week
Population: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tolterodine Tartrate | Risk Factors for the Proportion of Responders of Tolterodine-Severity of Overactive Bladder | 2426 participants |
| Without Concomitant Drugs | Risk Factors for the Proportion of Responders of Tolterodine-Severity of Overactive Bladder | 3709 participants |
| Severe | Risk Factors for the Proportion of Responders of Tolterodine-Severity of Overactive Bladder | 401 participants |
p-value: =0.006Chi-squared
Secondary
Risk Factors for the Proportion of Responders of Tolterodine-Urinary Urgency
Number of participants with responders of tolterodine to determine whether with or without Urinary urgency is significant risk factor.
Time frame: 12 week
Population: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tolterodine Tartrate | Risk Factors for the Proportion of Responders of Tolterodine-Urinary Urgency | 5529 participants |
| Without Concomitant Drugs | Risk Factors for the Proportion of Responders of Tolterodine-Urinary Urgency | 829 participants |
p-value: <0.001Chi-squared