Validation of a Real-Time Urodynamic Measure of Urinary Urgency

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by:
Loyola University
ClinicalTrials.gov Identifier:
NCT00909428
First received: May 26, 2009
Last updated: May 27, 2009
Last verified: May 2009

May 26, 2009
May 27, 2009
January 2007
July 2008   (final data collection date for primary outcome measure)
Urgency as measured continuously during filling cystometry [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00909428 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Validation of a Real-Time Urodynamic Measure of Urinary Urgency
Validation of a Real-Time Urodynamic Measure of Urinary Urgency as a Measure of the Success of Drug Treatment

Evaluating the effect of VesicareR 10 mg (Solifenacin, Astellas Inc) QD, on the urgency level as recorded by the filling phase of urodynamic testing, in patients with overactive bladder. In this pilot study, 10 patients with overactive bladder syndrome (OAB) symptoms and who have previously undergone urodynamic testing which demonstrated detrusor overactivity and who are not currently receiving an anticholinergic drug, will be recruited from our clinic. Patients will take Vesicare 10 mg daily for 1 month, then undergo repeat urodynamic testing for repeat evaluation of the urgency level during the filling phase.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Overactive Bladder Syndrome
Drug: Solifenacin 10mg
Daily for one month
Other Name: Vesicare 10mg po daily
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
February 2009
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have symptoms of urge or mixed incontinence (urge predominant) and desire treatment with anticholinergic medication. Symptoms are established by responses to the MESA questionnaire, already completed as part of routine clinical care.
  • Demonstrated detrusor overactivity with or without incontinence during urodynamic testing, during routine clinical care.
  • Are able to consent and fill out study documents, complete repeated urodynamic testing and follow up in 4 weeks.

Exclusion Criteria:

  • Have been treated with any anticholinergic medication in the previous month.
  • Have an elevated post -void residual volume as determined during their routine clinical care.
  • Have had a urinary tract infection in the last month, as determined by history.
  • Have untreated narrow angle glaucoma, by patient history.
  • Have a known allergy or intolerance to VesicareR, as determined by patient history.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00909428
109248
No
Mary Pat Fitzgerald, Loyola University Chicago
Loyola University
Astellas Pharma Inc
Not Provided
Loyola University
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP