Urinary Urgency Outcomes Following Propiverine Treatment for an Overactive Bladder
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.
Drug: Propiverine hydrochloride
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Urinary Urgency Outcomes Following Propiverine Treatment for an Overactive Bladder: PRopiverine Study on Overactive Bladder Including Urgency Data (PROUD)|
- Percent change in mean number of urgency episode [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]
- Change in the patients' perception of urgency [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: Yes ]
- Change in urgency severity/voids [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: Yes ]
- Change in sum of urgency severity/24 hours [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: Yes ]
- Changes in voiding frequency/24hrs, daytime and nocturnal voiding frequency/24 hours [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2005|
|Study Completion Date:||August 2006|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
Drug: Propiverine hydrochloride
Propiverine hydrochloride 20mg twice a day
Other Name: BUP-4
|Placebo Comparator: 2||
Identical placebo twice a day
Other Name: Placebo
12-week multi-center, prospective, parallel, double-blind, placebo-controlled trial