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Completed

NCT Number: NCT01488578

Tolterodine Drug Use Investigation.(Post Marketing Commitment Plan)

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.

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tolterodine tartrate

Drug

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

Other names: Detrusitol Capsule,Tolterodine tartrate.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs

    Time frame: 12 week

    Number of participants with responders of tolterodine to determine whether with or without concomitant drugs is significant risk factor.

  2. Risk Factors for the Proportion of Responders of Tolterodine-Non-drug Therapies

    Time frame: 12 week

    Number of participants with responders of tolterodine to determine whether with or without Non-drug therapies is significant risk factor.

  3. Risk Factors for the Proportion of Responders of Tolterodine-Gender

    Time frame: 12 week

    Number of participants with responders of tolterodine to determine whether male or female is significant risk factor.

  4. Risk Factors for the Proportion of Responders of Tolterodine-Complications

    Time frame: 12 week

    Number of participants with responders of tolterodine to determine whether with or without complications is significant risk factor.

  5. Risk Factors for the Proportion of Responders of Tolterodine-Age

    Time frame: 12 week

    Number of participants with responders of tolterodine to determine whether <65 years or >=65 years is significant risk factor.

  6. Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Tolterodine - Comorbidity of Prostatic Hypertrophy

    Time frame: 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.

  7. Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants

    Time frame: 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.

  8. Risk Factors for the Proportion of Responders of Tolterodine-Severity of Overactive Bladder

    Time frame: 12 week

    Number of participants with responders of tolterodine to determine whether mild, moderate or severe is significant risk factor.

  9. Risk Factors for the Proportion of Responders of Tolterodine-Urinary Urgency

    Time frame: 12 week

    Number of participants with responders of tolterodine to determine whether with or without Urinary urgency is significant risk factor.

  10. Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinations Per Day (During Sleep)

    Time frame: 12 week

    Number of participants with responders of tolterodine to determine the Number of urinations per day (during sleep) is significant risk factor.

  11. Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinary Incontinence Episodes Per Day

    Time frame: 12 week

    Number of participants with responders of tolterodine to determine the Number of urinary incontinence episodes per day is significant risk factor.

  12. Risk Factors for the Proportion of Responders of Tolterodine-Previous Treatment

    Time frame: 12 week

    Number of participants with response to tolterodine to determine whether with or without previous treatment is significant risk factor.

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study title

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

Acronym: POTTOR

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Dec 8, 2011
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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