Urinary Urgency Outcomes Following Propiverine Treatment for an Overactive Bladder
Status:
Completed
Trial end date:
2006-08-01
Target enrollment:
Participant gender:
Summary
Overactive bladder (OAB) is defined as "urgency, with or without urge incontinence, usually
with frequency and nocturia" in the absence of local pathological or endocrine factors.
Urgency is defined as "the complaint of a sudden compelling desire to pass urine that is
difficult to defer" and an abnormal sensation that is distinctly different from the normal
physiologic feeling of 'urge to void' that occurs during typical bladder-filling cycles.
Because up to 50% of patients with OAB experience urgency without incontinence, and because
urgency is the most bothersome symptom that drives behavioral adaptations such as frequent
voiding because of the very fear of urgency, this is the cornerstone symptom of OAB that
indicates the diagnosis of OAB.
Even though any effective treatment for OAB must reduce the patient's sense of urgency, its
subjective nature makes it difficult to measure. Therefore, the clinical efficacy of OAB
treatment was traditionally measured in terms of objective surrogate parameters instead of
urgency itself: for example, change in urinary frequency, incontinent episodes, number of
pads and urodynamically proven detrusor overactivity, which could be measured easily and
quantifiably.
Recently, several methods that measure urgency have been developed and used in clinical
practice. However, the analysis questioned the clinical significance of the results; a
possible reason for this being the lack of data based on urinary urgency and the use of
sensitive patient-driven criteria.
Propiverine hydrochloride (1-methyl-4-piperidyl diphenylpropoxyacetate hydrochloride) is a
drug with combined antimuscarinic and calcium antagonistic actions. Previous trials on the
clinical efficacy and safety of propiverine for treating patients with OAB have reported
improvements in urinary frequency and incontinence, but not in urgency.
The aim of this study was to explore the efficacy of a daily regimen of propiverine at 20 mg
(immediate release formulation) in improving urgency from baseline to 12 weeks of treatment
in patients with OAB.