drugset / Trial / NCT00909428

Validation of a Real-time Urodynamic Measure of Urinary Urgency

NCT00909428 ↗

Phase 4 Completed 51 enrolled Loyola University Astellas Pharma Inc · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2007-01
Primary completion
2008-07
Completion
2009-02

Outcome

Met primary endpoint

registry analysis (superiority test); Baseline Maximal Cystometric Capacity vs One Month Maximal Cystometric Capacity; p = .005; Z-Score 2.803; Wilcoxon signed rank test NCT00909428 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Solifenacin Small molecule 10 mg —

Indications