Tolterodine Drug Use Investigation.(Post Marketing Commitment Plan)

An observational study of Overactive Bladder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Overactive Bladder
What is being tested?: Tolterodine tartrate
Type of treatment: Pill or oral medicine
How many people: 11,157 participants
Where: No sites listed yet
Study dates: Dec 2006to Mar 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: The subjects whom an investigator involving A6121186 prescribes the Tolterodine tartrate (Detrusitol Capsule).

Who may be able to join

Male or female subjects intend to treat their overactive bladder who are prescribed Detrusitol Capsule by their physicians.

Who cannot join

Subjects who have been prescribed Detrusitol Capsule before.

About this study

Official title: Postmarketing Observational Study of Tolterodine Treatment on Overactive Bladder in Real Life Setting

Read the 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.

Conditions: Overactive Bladder
Being tested: Tolterodine tartrate
Keywords: Overactive Bladder, Japanese, Tolterodine, Detrusitol, Detrol, Postmarketing commitment plan.
Medical subject headings: Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tolterodine tartrateDrug
Also called Detrusitol Capsule,Tolterodine tartrate.
Detrusitol Capsule 2mg and 4mg, depending on the Investigator prescription.Frequency and duration are according to Package Insert as follows.

Study groups in NCT01488578
Study group	Role	What they receive
Tolterodine tartrate.		Subjects taking Tolterodine tartrate. Receives: Drug: Tolterodine tartrate

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 weeks
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.
Measured: 12 week
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.
Measured: 12 week
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.
Measured: 12 week

Secondary outcomes (12)

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.
Measured: 12 week
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.
Measured: 12 week
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.
Measured: 12 week
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.
Measured: 12 week
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.
Measured: 12 week
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.
Measured: 12 week
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.
Measured: 12 week
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.
Measured: 12 week
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.
Measured: 12 week
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.
Measured: 12 week
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.
Measured: 12 week
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.
Measured: 12 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2006Mar 2011

First posted8 Dec 2011 (estimated)
Study startDec 2006
Primary completionMar 2011
Study completionMar 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Overactive BladderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 11,157 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01488578
Sponsor's protocol ID: A6121186
Acronym: POTTOR
Status last verified: Jan 2021
First submitted: 27 Apr 2011
Last updated: 28 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
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All Overactive Bladder trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Postmarketing Observational Study of Tolterodine Treatment on Overactive Bladder in Real Life Setting
ClinicalTrials.gov ID: NCT01488578
Acronym / sponsor ID: POTTOR / A6121186
Conditions: Overactive Bladder
Keywords: Overactive Bladder, Japanese, Tolterodine, Detrusitol, Detrol, Postmarketing commitment plan.
Study type: Observational
Recruitment status: Completed
Enrolment: 11,157 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Dec 2006
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 8 Dec 2011 (estimated)
Results: Posted 14 Jun 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Tolterodine tartrate.	–	Drug: Tolterodine tartrateSubjects taking Tolterodine tartrate.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: The subjects whom an investigator involving A6121186 prescribes the Tolterodine tartrate (Detrusitol Capsule).

Key inclusion criteria (1 listed)

Male or female subjects intend to treat their overactive bladder who are prescribed Detrusitol Capsule by their physicians.

Key exclusion criteria (1 listed)

Subjects who have been prescribed Detrusitol Capsule before.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tolterodine tartrateAlso: Detrusitol Capsule,Tolterodine tartrate.Detrusitol Capsule 2mg and 4mg, depending on the Investigator prescription.Frequency and duration are according to Package Insert as follows.	Drug	Tolterodine tartrate.

Primary outcome

Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs).
Time frame: 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".
Time frame: 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.
Time frame: 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.
Time frame: 12 week
The Treatment Related Adverse Events (TRAEs) at the end of observation period with an incidence of 1% or higher.

12 secondary outcomes

Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs
Time frame: 12 week
Risk Factors for the Proportion of Responders of Tolterodine-Non-drug Therapies
Time frame: 12 week
Risk Factors for the Proportion of Responders of Tolterodine-Gender
Time frame: 12 week
Risk Factors for the Proportion of Responders of Tolterodine-Complications
Time frame: 12 week
Risk Factors for the Proportion of Responders of Tolterodine-Age
Time frame: 12 week
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Tolterodine - Comorbidity of Prostatic Hypertrophy
Time frame: 12 week
Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants
Time frame: 12 week
Risk Factors for the Proportion of Responders of Tolterodine-Severity of Overactive Bladder
Time frame: 12 week
Risk Factors for the Proportion of Responders of Tolterodine-Urinary Urgency
Time frame: 12 week
Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinations Per Day (During Sleep)
Time frame: 12 week
Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinary Incontinence Episodes Per Day
Time frame: 12 week
Risk Factors for the Proportion of Responders of Tolterodine-Previous Treatment
Time frame: 12 week

Results and safety

Results posted to the registry on 14 Jun 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tolterodine Tartrate	11,157	9,321

Primary outcome: Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs).

Time frame: 12 weeks. Number. Unit: participants

Measure	Tolterodine Tartrate n = 9321
Value	984

Population analysed: Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of Detrusitol.

Primary outcome: Number of Participants Which Was Evaluated as "Degree of Satisfaction".

Time frame: 12 week. Number. Unit: participants

Measure	Tolterodine Tartrate n = 7780
Satisfied	5609
Dissatisfied	1033
Neither of the above	963
Unknown	175

Population analysed: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).

Primary outcome: Number of Participants With an Investigator's Assessment of Clinical Outcome at End of the Study.

Time frame: 12 week. Number. Unit: participants

Measure	Tolterodine Tartrate n = 7780
Effective	6536
Not effective	1244

Population analysed: 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".

Primary outcome: Confirmation of Frequent Treatment Related Adverse Events (TRAEs) at the End of Observation Period.

Time frame: 12 week. Number. Unit: events

Measure	Tolterodine Tartrate n = 9321
Thirst	344
Constipation	194
Dysuria	166

Population analysed: Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of Detrusitol.

12 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tolterodine Tartrate	12 of 9,321 (0.1%)	703 of 9,321 (7.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Overactive Bladder

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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

Questions about this trial

What is this clinical trial studying?

An observational study of Overactive Bladder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs). (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01488578.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.