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A Clinical Trial To Assess Fesoterodine On Treatment Satisfaction And Symptom Improvement In Overactive Bladder Patients

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00425100
First received: January 19, 2007
Last updated: February 24, 2009
Last verified: February 2009
History of Changes
Results First Received: October 10, 2008  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Overactive Bladder
Intervention: Drug: fesoterodine fumarate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled at 59 centers (Belgium 5 centers, Costa Rica 2, Czech Republic 4, Germany 7, Republic of Korea 6, Poland 2, Slovakia 5, Ukraine 5, United States 23). Two centers in the United States did not randomize subjects.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
595 subjects were screened. Responses to a 5-day bladder diary (during a 2-week screening period) identified subjects who met all other entry criteria for enrollment for study treatment.

Reporting Groups
  Description
Open Label-fesoterodine All enrolled subjects were treated with fesoterodine 4 mg once daily (QD) for 4 weeks followed by either 4 mg QD or 8 mg QD for the remaining 8 weeks of the study.

Participant Flow:   Overall Study
    Open Label-fesoterodine  
STARTED     516  
COMPLETED     463  
NOT COMPLETED     53  
Adverse Event                 36  
Lack of Efficacy                 4  
Lost to Follow-up                 2  
Protocol Violation                 4  
Withdrawal by Subject                 7  



  Baseline Characteristics
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Reporting Groups
  Description
Open Label-fesoterodine All enrolled subjects were treated with fesoterodine 4 mg once daily (QD) for 4 weeks followed by either 4 mg QD or 8 mg QD for the remaining 8 weeks of the study.

Baseline Measures
    Open Label-fesoterodine  
Number of Participants  
[units: participants]
 		  516  
Age  
[units: years]
Mean ± Standard Deviation 		  59.6  ± 13.6  
Gender  
[units: participants]
 		 
Female     398  
Male     118  



  Outcome Measures
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1.  Primary:   Mean Number of Micturition Episodes Per 24 Hours   [ Time Frame: Baseline and Week 12 ]
  Show Outcome Measure 1

2.  Primary:   Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours   [ Time Frame: Baseline and Week 12 ]
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3.  Primary:   Mean Number of Urgency Episodes Per 24 Hours   [ Time Frame: Baseline and Week 12 ]
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4.  Primary:   Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment   [ Time Frame: Week 12 ]
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5.  Secondary:   Nocturnal Micturitions Per 24 Hours   [ Time Frame: Baseline and Week 12 ]
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6.  Secondary:   Severe Urgency Episodes Per 24 Hours   [ Time Frame: Baseline and Week 12 ]
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7.  Secondary:   Mean Rating on the Urinary Sensation Scale   [ Time Frame: Baseline and Week 12 ]
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8.  Secondary:   Patient Perception of Bladder Condition (PPBC) Score   [ Time Frame: Baseline and Week 12 ]
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9.  Secondary:   Patient Perception of Bladder Condition (PPBC) Score at Week 12 Relative to Baseline (Categorical Change)   [ Time Frame: Baseline and Week 12 ]
  Show Outcome Measure 9

10.  Secondary:   Urgency Perception Scale (UPS)   [ Time Frame: Baseline and Week 12 ]
  Hide Outcome Measure 10

Measure Type Secondary
Measure Title Urgency Perception Scale (UPS)
Measure Description UPS scores range from 0 (“I am usually not able to hold urine”) to 2 (“I am usually able to finish what I am doing before going to the toilet [without leaking]”).
Time Frame Baseline and Week 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.

Reporting Groups
  Description
Open Label Baseline No text entered.
Open Label Week 12 No text entered.

Measured Values
    Open Label Baseline     Open Label Week 12  
Number of Participants Analyzed  
[units: participants]
 		  485     485  
Urgency Perception Scale (UPS)  
[units: scores on a scale]
Mean ± Standard Deviation 		  0.8  ± 0.5     1.4  ± 0.6  


Statistical Analysis 1 for Urgency Perception Scale (UPS)
Groups [1] All groups
Method [2] 2-sided paired t-test
P Value [3] <0.0001
Mean Difference (Net) [4] 0.5
Standard Deviation ± 0.7
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is an open-label study with statistical comparison between baseline and Week 12.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.
[4] Other relevant estimation information:
  No text entered.



11.  Secondary:   Urgency Perception Scale (UPS) at Week 12 Relative to Baseline (Categorical Change)   [ Time Frame: Baseline and Week 12 ]
  Show Outcome Measure 11

12.  Secondary:   Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Concern Domain   [ Time Frame: Baseline and Week 12 ]
  Show Outcome Measure 12

13.  Secondary:   Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Coping Domain   [ Time Frame: Baseline and Week 12 ]
  Show Outcome Measure 13

14.  Secondary:   Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Sleep Domain   [ Time Frame: Baseline and Week 12 ]
  Show Outcome Measure 14

15.  Secondary:   Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Social Interaction Domain   [ Time Frame: Baseline and Week 12 ]
  Show Outcome Measure 15

16.  Secondary:   Overactive Bladder Questionnaire (OAB-q) - Total Health Related Quality of Life (HRQL) Scale   [ Time Frame: Baseline and Week 12 ]
  Show Outcome Measure 16

17.  Secondary:   Overactive Bladder Questionnaire (OAB-q) - Symptom Bother Scale   [ Time Frame: Baseline and Week 12 ]
  Show Outcome Measure 17

18.  Secondary:   "Satisfaction With OAB Control" Module of Overactive Bladder (OAB) Treatment Satisfaction Questionnaire (TSQ) (OAB-S)   [ Time Frame: Week 12 ]
  Show Outcome Measure 18

19.  Secondary:   Sum Rating on the Urinary Sensation Scale   [ Time Frame: Baseline and Week 12 ]
  Show Outcome Measure 19

20.  Secondary:   Treated Subjects Reporting Satisfaction With Their Current OAB Treatment (Supportive Analysis)   [ Time Frame: Week 12 ]
  Show Outcome Measure 20


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
None.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com


No publications provided by Pfizer

Publications automatically indexed to this study:


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00425100     History of Changes
Other Study ID Numbers: A0221007
Study First Received: January 19, 2007
Results First Received: October 10, 2008
Last Updated: February 24, 2009
Health Authority: United States: Food and Drug Administration