Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Comparative Urine Proteomic Studies of Overactive Bladder in Humans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01367886
First received: May 19, 2011
Last updated: February 10, 2015
Last verified: February 2015
Results First Received: July 9, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Overactive Bladder
Intervention: Drug: fesoterodine

  Participant Flow
  Hide Participant Flow

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
  Hide Baseline Characteristics

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  
Number of Participants  
[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
  Hide 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
No serious adverse events.


  More Information
  Hide More Information

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
Study First Received: May 19, 2011
Results First Received: July 9, 2013
Last Updated: February 10, 2015
Health Authority: United States: Institutional Review Board