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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01260311
First received: November 22, 2010
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Over Active Bladder
Drug: Fesoterodine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Marketing Surveillance To Assess The Safety And Efficacy Of Fesoterodine (Toviaz) On Filipino Patients Diagnosed With Over-Active Bladder

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment [ Time Frame: Baseline up to 28 days after last dose ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Number of Micturitions Per 24 Hours at Week 4 and Week 8 [ Time Frame: Week 4 and Week 8 ] [ Designated as safety issue: No ]
    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.

  • Number of Urgency Episodes Per 24 Hours at Week 4 and Week 8 [ Time Frame: Week 4 and Week 8 ] [ Designated as safety issue: No ]
    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.

  • Number of UUI Episodes Per 24 Hours at Week 4 and Week 8 [ Time Frame: Week 4 and Week 8 ] [ Designated as safety issue: No ]
    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.

  • Patient Perception of Bladder Condition (PPBC) at Week 4 and Week 8 [ Time Frame: Week 4 and Week 8 ] [ Designated as safety issue: No ]
    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.


Enrollment: 508
Study Start Date: February 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients prescribed with Fesoterodine
Patients diagnosed with Over-active bladder and prescribed with fesoterodine.
Drug: Fesoterodine
Any dose of Fesoterodine
Other Name: Toviaz

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed with Over-active bladder

Criteria

Inclusion Criteria:

  • Over-active bladder
  • Prescribed with Fesoterodine

Exclusion Criteria:

  • Hypersensitivity
  • Urinary retention
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01260311

Locations
Philippines
Mary Johnston Hospital, Inc.
Tondo, Manila, Philippines, 1000
East Avenue Medical Center
Diliman, Quezon City, Metro Manila, Philippines, 1101
The Medical City
Pasig City, Metro Manila, Philippines, 1605
St. Luke's Medical Center
Quezon City, Metro Manila, Philippines, 1102
Private Clinic
Baguio City, Philippines
Private Clinic
Batangas, Philippines
Cebu Doctors Hospital, Osmena Blvd.,
Cebu, Philippines
Davao Doctors Hospital
Davao, Philippines
Davao Medical School Foundation Hospital
Davao, Philippines
Private Clinic
Davao City, Philippines
Room 120, Davao Medical School Foundation Hospital
Davao City, Philippines
Davao Doctors Tower
Davao City, Philippines
Private Clinic
Ilocos Norte, Philippines
Private Clinic
La Union, Philippines
Private Clinic
Laguna, Philippines
Lucena United Doctors Hospital
Lucena City, Philippines, 4301
Private Clinic
Makati City, Philippines
Room 314 Main Building
Makati City, Philippines
Makati Medical Center
Makati City, Philippines, 1200
VRPMC
Mandaluyong, Philippines
Medical Center Manila
Manila, Philippines, 1000
Private Clinic
Manila, Philippines
Santo Tomas University Hospital
Manila, Philippines
University of Sto. Tomas Hospital
Manila, Philippines, 1000
Ospital ng Maynila Medical Center
Manila, Philippines
Private Clinic
Muntinlupa City, Philippines
Private Clinic
Nueva Ecija, Philippines
Healthway Medical, The Block
Philippines, Philippines
Private Clinic
Quezon, Philippines
East Avenue Medical Center
Quezon, Philippines
Private Clinic
Quezon City, Philippines
St. Luke's Medical Center, North Tower, CHBC
Quezon City, Philippines, 1100
Private Clinic
South Luzon, Philippines
Central Luzon Doctor's Hospital
Tarlac City, Philippines
Fatima Medical Center, Inc.
Valenzuela, Philippines
F.E.U. - Nicanor Reyes Medical Foundation Medical Center
West Fairview, Quezon City, Philippines, 1100
Urology Clinic
Zamboanga City, Philippines
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01260311     History of Changes
Other Study ID Numbers: A0221085
Study First Received: November 22, 2010
Results First Received: September 4, 2014
Last Updated: September 4, 2014
Health Authority: Philippines : Food and Drug Administration

Keywords provided by Pfizer:
Observational

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Fesoterodine
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on October 23, 2014