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Validation of a Real-time Urodynamic Measure of Urinary Urgency

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00909428
First Posted: May 28, 2009
Last Update Posted: May 24, 2017
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.
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Loyola University
Results First Submitted: August 21, 2009  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Overactive Bladder Syndrome
Intervention: Drug: Solifenacin Succinate

  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
Fifty-one individuals were consented and 42 women with overactive bladder (OAB) received study drug between January 2007 and February 2009. Participants were recruited using physician solicitation.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Following informed consent, nine women were negative for OAB and did not receive solifenacin succinate

Reporting Groups
  Description
Detrusor Overactivity Incontinence (DOI) Patients in this cohort were diagnosed with detrusor overactivity incontinence (DOI).
Urodynamic Stress Incontinence (USI) Patients in this cohort were diagnosed with urodynamic stress incontinence (USI)
Mixed Incontinence (DOI-USI) Patients in this cohort were diagnosed with both detrusor overactivity incontinence (DOI) and urodynamic stress incontinence (USI)

Participant Flow:   Overall Study
    Detrusor Overactivity Incontinence (DOI)   Urodynamic Stress Incontinence (USI)   Mixed Incontinence (DOI-USI)
STARTED   18   15   9 
COMPLETED   5   5   0 
NOT COMPLETED   13   10   9 
Lost to Follow-up                13                10                9 



  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 baseline analysis population comprises all women who signed informed consent and have a valid diagnosis of OAB

Reporting Groups
  Description
Detrusor Overactivity Incontinence (DOI) Patients in this cohort were diagnosed with detrusor overactivity incontinence (DOI)
Urodynamic Stress Incontinence (USI) Patients in this cohort were diagnosed with urodynamic stress incontinence (USI)
Mixed Incontinence (DOI-USI) Patients in this cohort were diagnosed with both detrusor overactivity incontinence (DOI) and urodynamic stress incontinence (USI)
Total Total of all reporting groups

Baseline Measures
   Detrusor Overactivity Incontinence (DOI)   Urodynamic Stress Incontinence (USI)   Mixed Incontinence (DOI-USI)   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   15   9   42 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      14  77.8%      11  73.3%      9 100.0%      34  81.0% 
>=65 years      4  22.2%      4  26.7%      0   0.0%      8  19.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      18 100.0%      15 100.0%      9 100.0%      42 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   Change in Maximal Cystometric Capacity (mL)   [ Time Frame: 30 Days ]


  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
The trial experienced significant attrition. Otherwise, there are no limitations or caveats to report.


  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: Mary P FitzGerald
Organization: Loyola University Chicago
phone: 708-216-2170
e-mail: mfitzg8@lumc.edu


Publications:

Responsible Party: Loyola University
ClinicalTrials.gov Identifier: NCT00909428     History of Changes
Other Study ID Numbers: 109248
First Submitted: May 26, 2009
First Posted: May 28, 2009
Results First Submitted: August 21, 2009
Results First Posted: May 24, 2017
Last Update Posted: May 24, 2017