NCT00909428

Validation of a Real-time Urodynamic Measure of Urinary Urgency

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Loyola University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 their urinary urgency using the Urgeometer. The Urgeometer lever marks a continuous scale from 0 'no urge at all' to 100 'maximum urge which you can tolerate'. The testing is stopped once the bladder is filled. To minimize the chance of infection, participants receive one dose of oral antibiotics prior to the bladder testing. Following completion of the bladder test, participants will take 10mg solifenacin succinate (VesicareR) daily for 30 days. Afterward, participants repeat the bladder test. The change in participants' maximal tolerated cystometric capacity (MCC) will be measured in milliliters and used to evaluate the effectiveness of the drug.

Conditions

• Overactive Bladder Syndrome

Interventions

Type	Name	Description
DRUG	Solifenacin Succinate	Participants take 10mg daily solifenacin succinate for 30 days

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-07-01
• Completion: 2009-02-01
• First posted: 2009-05-28
• Last updated: 2017-05-24
• Results posted: 2017-05-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study