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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:
ClinicalTrials.gov Identifier:
NCT00425100
First Posted: January 22, 2007
Last Update Posted: March 23, 2009
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.
Information provided by:
Pfizer
Results First Submitted: October 10, 2008  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (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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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.
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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 
Overall Participants Analyzed 
[Units: Participants]
 516 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.6  (13.6) 
Gender 
[Units: Participants]
 
Female   398 
Male   118 


  Outcome Measures
  Show All Outcome Measures

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

2.  Primary:   Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours   [ Time Frame: Baseline and Week 12 ]

3.  Primary:   Mean Number of Urgency Episodes Per 24 Hours   [ Time Frame: Baseline and Week 12 ]

4.  Primary:   Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment   [ Time Frame: Week 12 ]

5.  Secondary:   Nocturnal Micturitions Per 24 Hours   [ Time Frame: Baseline and Week 12 ]

6.  Secondary:   Severe Urgency Episodes Per 24 Hours   [ Time Frame: Baseline and Week 12 ]

7.  Secondary:   Mean Rating on the Urinary Sensation Scale   [ Time Frame: Baseline and Week 12 ]

8.  Secondary:   Patient Perception of Bladder Condition (PPBC) Score   [ Time Frame: Baseline and Week 12 ]

9.  Secondary:   Patient Perception of Bladder Condition (PPBC) Score at Week 12 Relative to Baseline (Categorical Change)   [ Time Frame: Baseline and Week 12 ]

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

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

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

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

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

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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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.


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


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

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00425100     History of Changes
Other Study ID Numbers: A0221007
First Submitted: January 19, 2007
First Posted: January 22, 2007
Results First Submitted: October 10, 2008
Results First Posted: February 10, 2009
Last Update Posted: March 23, 2009