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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Overactive Bladder Syndrome
 Drug: Solifenacin 10mg
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Validation of a Real-Time Urodynamic Measure of Urinary Urgency as a Measure of the Success of Drug Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Loyola University:

Primary Outcome Measures:
  • Urgency as measured continuously during filling cystometry [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: January 2007
Study Completion Date: February 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Solifenacin 10mg
    Daily for one month
    Other Name: Vesicare 10mg po daily
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909428

Locations
United States, Illinois
Loyola University Health System
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
Loyola University
Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Mary Pat Fitzgerald, Loyola University Chicago
ClinicalTrials.gov Identifier: NCT00909428     History of Changes
Other Study ID Numbers: 109248
Study First Received: May 26, 2009
Last Updated: May 27, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Loyola University:
overactive bladder syndrome
lower urinary tract
urgency
 solifenacin
pharmacotherapy
urodynamic testing

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Muscarinic Antagonists
 Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013