Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Non-Interventional Study To Investigate Whether Information Provided To Patients Influences Their Satisfaction With Toviaz Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01091519
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : March 24, 2010
Results First Posted : March 7, 2013
Last Update Posted : March 7, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Collect information on treatment with Toviaz (fesoterodine) under ordinary prescribing conditions, and to investigate whether additional educational information affects satisfaction with treatment as perceived by the patient.

Condition or disease Intervention/treatment
Urinary Bladder, Overactive Other: Toviaz(fesoterodine) plus educational materials Other: Toviaz(fesoterodine) without educational materials

Detailed Description:
Patients will be identified and monitored during routine clinical practice visits, and will not be specifically selected as this would interfere with the representativeness of the results. The study will be conducted with office-based urologists and office-based general physicians, practitioners and internists (GPs) in Germany, thus representing a wide range of practices and populations. Each urologist or GP may invite patients to participate who have already been diagnosed with overactive bladder and prescribed Toviaz according to their usual standard of care. Study enrollment stopped on December 31, 2011 due to difficulty in recruiting patients. No safety issues were related to the decision to stop patient enrollment.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 781 participants
Time Perspective: Prospective
Official Title: Facts Study (Fakten-studie): Non-interventional Study to Investigate Whether Information Provided to Patients Influences Satisfaction With Toviaz Therapy As Perceived by the Patient
Study Start Date : December 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Toviaz(fesoterodine) plus educational materials Other: Toviaz(fesoterodine) plus educational materials
Educational materials including the Self-Assessment Goal Achievement (SAGA) tool to support dialogue.
Toviaz(fesoterodine) alone
Toviaz(fesoterodine) without additional educational materials
 Other: Toviaz(fesoterodine) without educational materials
No educational materials


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Percentage of Participants Satisfied With Treatment at Month 4 [ Time Frame: Month 4 ]
    Participant's response to treatment was based on treatment satisfaction questionnaires (TSQ). Participants answered: "overall, how satisfied are you with your OAB medication?" and were asked to rate this question on 5 point scale as 1=very satisfied, 2=somewhat satisfied, 3= neither dissatisfied nor satisfied, 4=somewhat dissatisfied and 5=very dissatisfied. Five categorical responses were grouped to satisfied (including "very satisfied" and "somewhat satisfied") and dissatisfied (including "very dissatisfied", "somewhat dissatisfied", and "neither dissatisfied nor satisfied").


Secondary Outcome Measures :
  1. Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 [ Time Frame: Baseline, Week 4, Month 4 ]
    PPBC: single-item, self-administered validated questionnaire. Rated on a 6-point scale: participant was asked: "Which of the following statements describes your bladder condition best at the moment?" 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. Change from baseline results categorized as deterioration (Positive change from baseline); no Change (scores change=0); minor Improvement (negative score change in magnitude of 1); major improvement (negative score change in magnitude of >=2).

  2. Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4 [ Time Frame: Baseline, Week 4, Month 4 ]
    PPUS: single-item, self-administered validated questionnaire. Rated on a 3-point scale: participant was asked: "Which of the following would typically describe your experience when you have a desire to urinate?" 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change from baseline results categorized as deterioration (Negative change); no change (Score change=0); improvement (Positive change).

  3. Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4 [ Time Frame: Baseline, Week 4, Month 4 ]
    Participant's response to the treatment was based on treatment satisfaction questionnaires (TSQ). TSQ was rated on a 5-point scale, participant was asked: "overall how satisfied are you with your over active bladder (OAB) medication?" 1=very satisfied, 2=somewhat satisfied, 3=neither dissatisfied nor satisfied, 4=somewhat dissatisfied, 5=very dissatisfied. Change from baseline results categorized as deterioration (Positive change from baseline);no change (scores change=0);minor improvement (negative score change in magnitude of 1);major improvement (negative score change in magnitude of >=2).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with overactive bladder symptoms presenting during routine clinical practice visits
Criteria

Inclusion Criteria:

Patients with increased urinary frequency and/or imperative urgency and/or urge incontinence, as can occur in patients with overactive bladder syndrome, for whom Toviaz was prescribed for treatment of the symptoms.

Patients will complete the OABv8 questionnaire and will need to meet a minimum score in order to be eligible for the study.

Exclusion Criteria:

Patients who meet the contraindications in the Toviaz prescribing information (active ingredient fesoterodine) will be excluded.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01091519


Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01091519    
Other Study ID Numbers: A0221073
FACTS (FAKTEN) study
First Posted: March 24, 2010    Key Record Dates
Results First Posted: March 7, 2013
Last Update Posted: March 7, 2013
Last Verified: January 2013
Keywords provided by Pfizer:
Non-interventional study fesoterodine educational materials
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Fesoterodine
Muscarinic Antagonists
 Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents