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Validation of a Real-Time Urodynamic Measure of Urinary Urgency

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

Further study details as provided by Loyola University:

Primary Outcome Measures:
  • Urgency as measured continuously during filling cystometry [ Time Frame: 1 month ]

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00909428

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

Responsible Party: Mary Pat Fitzgerald, Loyola University Chicago Identifier: NCT00909428     History of Changes
Other Study ID Numbers: 109248
Study First Received: May 26, 2009
Last Updated: May 27, 2009

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

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solifenacin Succinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents processed this record on April 28, 2017