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Comparative Urine Proteomic Studies of Overactive Bladder in Humans

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01367886
First Posted: June 7, 2011
Last Update Posted: February 27, 2015
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 (Responsible Party):
Washington University School of Medicine
Results First Submitted: July 9, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition: Overactive Bladder
Intervention: Drug: fesoterodine

  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 with overactive bladder were recruited from principal investigator's clinic practice.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Overactive bladder subjects completed a 3-day bladder diary and the Overactive Bladder questionnaire (OAB-q) prior to starting Toviaz (Fesoterodine) 4 mg daily. Another 3-day bladder diary and Overactive Bladder questionnaire (OAB-q) was completed by each subject at the end of a 6-week treatment with Toviaz.

No washout period.


Reporting Groups
  Description
Fesoterodine

Females with overactive bladder symptoms were given Fesoterodine 4 mg. daily for six weeks.

Fesoterodine : Fesoterodine 4 mg. tablet by mouth daily for six weeks


Participant Flow:   Overall Study
    Fesoterodine
STARTED   21 
COMPLETED   14 
NOT COMPLETED   7 
Lost to Follow-up                4 
Lack of Efficacy                2 
Death                1 



  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.
The overall number of participants is 21. The 21 participants that took Fesoterodine were the basis for analysis.

Reporting Groups
  Description
Fesoterodine Overactive bladder subjects took Fesoterodine 4 mg daily for 6 weeks.

Baseline Measures
   Fesoterodine 
Overall Participants Analyzed 
[Units: Participants]
 21 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   19 
>=65 years   2 
Gender 
[Units: Participants]
 
Female   21 
Male   0 
Region of Enrollment 
[Units: Participants]
 
United States   21 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Bladder Diary to Assess Urinary Frequency at Baseline and at End of 6-week Treatment   [ Time Frame: Outcome measure was assessed at baseline and at the end of the 6-week treatment ]

2.  Primary:   Bladder Diary (Using Urinary Sensation Scale Found in Bladder Diary) to Assess Urinary Urgency at Baseline and at 6-week Treatment   [ Time Frame: Outcome measure was assesses at baseline and at the end of the 6-week treatment period. ]

3.  Secondary:   Overactive Bladder Questionnaire (OAB-q) to Assess Bother From Urinary Frequency at Baseline and at 6 Weeks.   [ Time Frame: Outcome measure was assessed at baseline and after the 6 week visit. ]

4.  Secondary:   Overactive Bladder Questionnaire (OAB-q) Will be Used to Assess Bother From Urinary Urgency at Baseline and at 6 Weeks..   [ Time Frame: Outcome measures were assessed at baseline and after the 6 week visit. ]


  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
No serious adverse events.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: H. Henry Lai, MD
Organization: Washington University School of Medicine
phone: 314-362-8295
e-mail: laih@wudosis.wustl.edu



Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01367886     History of Changes
Other Study ID Numbers: WS473527
First Submitted: May 19, 2011
First Posted: June 7, 2011
Results First Submitted: July 9, 2013
Results First Posted: January 12, 2015
Last Update Posted: February 27, 2015