Validation of a Real-time Urodynamic Measure of Urinary Urgency

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: Female

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 the term 'urgency' and there is no good tool to evaluate the severity of urgency. This fact has constrained the performance of clinical research in this field. The cause of urinary urgency is not fully understood and may vary from patient to patient.

Although clinicians regularly obtain measures of bladder sensation during cystometry, little attention has been paid to the patient experience of urinary urgency. In this study, the researchers will use a non-significant risk device (i.e., an Urgeometer) to measure urinary urgency in women with overactive bladder.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Loyola University
• Collaborator: Astellas Pharma Inc
• Treatments: Solifenacin Succinate

Criteria

Inclusion Criteria:

• 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 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 solifenacin, as determined by patient history.