Status:
COMPLETED
Validation of a Real-time Urodynamic Measure of Urinary Urgency
Lead Sponsor:
Loyola University
Collaborating Sponsors:
Astellas Pharma Inc
Conditions:
Overactive Bladder Syndrome
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
Urinary urgency is a key symptom of overactive bladder syndrome (OAB) and may be more bothersome to a patient than the symptom of urinary frequency. Unfortunately, controversy continues to surround th...
Detailed Description
At baseline, a small catheter is placed inside the participant's bladder. The bladder is filled with sterile water through the catheter. As the bladder is filled, the participant is asked to rate thei...
Eligibility Criteria
Inclusion
- Have symptoms of urge or mixed incontinence (urge predominant) and desire treatment with anticholinergic medication.
- Demonstrated detrusor overactivity with or without incontinence during urodynamic testing.
- Are able to consent and fill out study documents, complete repeated urodynamic testing, and follow-up in 4 weeks.
Exclusion
- 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 solifenacin, as determined by patient history.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00909428
Start Date
January 1 2007
End Date
February 1 2009
Last Update
May 24 2017
Active Locations (1)
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1
Loyola University Medical Center
Maywood, Illinois, United States, 60153