A Phase 4 interventional study of Propiverine hydrochloride and Placebo in Overactive Bladder, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-05-15.
Sponsored by Samsung Medical Center · Phase 4, Interventional, and Treatment
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.
12-week multi-center, prospective, parallel, double-blind, placebo-controlled trial
855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.
This study's enrollment of 264 is above the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
3 day- voiding diary
Exclusion Criteria:
Drug: Propiverine hydrochloride
Drug: Placebo
Propiverine hydrochloride 20mg twice a day
Also known as: BUP-4
Identical placebo twice a day
Percent change in mean number of urgency episode
Time frame: 12 weeks of treatment
Change in the patients' perception of urgency
Time frame: 12 weeks of treatment
Change in urgency severity/voids
Time frame: 12 weeks of treatment
Change in sum of urgency severity/24 hours
Time frame: 12 weeks of treatment
Changes in voiding frequency/24hrs, daytime and nocturnal voiding frequency/24 hours
Time frame: 12 weeks of treatment
This study is completed, as verified in May 2009. You cannot join it, but the record below documents what was studied.
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Samsung Medical Center