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Completed

NCT Number: NCT01260311

Post Marketing Surveillance Of Fesoterodine In Filipino Patients With Over Active Bladder

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.

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Key information

Conditions

Over Active Bladder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mary Johnston Hospital, Inc., Tondo, Manila, Philippines

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About this study

Sampling method is not applicable in this study. Only patients prescribed Fesoterodine will be enrolled.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Over-active bladder
  • Prescribed with Fesoterodine

Exclusion criteria

  • Hypersensitivity
  • Urinary retention

Treatment and study plan

Fesoterodine

Drug

Any dose of Fesoterodine

Other names: Toviaz

Primary outcomes

  1. Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment

    Time frame: 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 outcomes

  1. Number of Micturitions Per 24 Hours at Week 4 and Week 8

    Time frame: 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.

  2. Number of Urgency Episodes Per 24 Hours at Week 4 and Week 8

    Time frame: 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.

  3. Number of UUI Episodes Per 24 Hours at Week 4 and Week 8

    Time frame: 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.

  4. Patient Perception of Bladder Condition (PPBC) at Week 4 and Week 8

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Post Marketing Surveillance To Assess The Safety And Efficacy Of Fesoterodine (Toviaz) On Filipino Patients Diagnosed With Over-Active Bladder

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 15, 2010
Registry last updated
Sep 11, 2014

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

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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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