Validation of a Real-Time Urodynamic Measure of Urinary Urgency

Overactive Bladder Syndrome Clinical Trial

Official title:

Validation of a Real-Time Urodynamic Measure of Urinary Urgency as a Measure of the Success of Drug Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00909428
• Other study ID #: 109248
• Status: Completed
• Phase: Phase 4
• First received: May 26, 2009
• Last updated: May 27, 2009
• Start date: January 2007
• Est. completion date: February 2009

Study information

• Verified date: May 2009
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder Syndrome
• Urinary Bladder, Overactive

Intervention

Drug:
• Solifenacin 10mg
Daily for one month

Locations

Country	Name	City	State
United States	Loyola University Health System	Maywood	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Loyola University	Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urgency as measured continuously during filling cystometry		1 month	No