Urinary Urgency Outcomes Following Propiverine Treatment for an Overactive Bladder

Study Overview
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Brief Summary
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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.

Detailed Description
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12-week multi-center, prospective, parallel, double-blind, placebo-controlled trial

Official Title
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Urinary Urgency Outcomes Following Propiverine Treatment for an Overactive Bladder: PRopiverine Study on Overactive Bladder Including Urgency Data (PROUD)

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: Propiverine hydrochloride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 18 years Overactive bladder for at least 3 months 3 day- voiding diary average urinary frequency ≥ 10 voids/24hrs urgency ≥ 2 episodes/24hrs moderate to severe in the Indevus Urgency Severity Scale (IUSS) Exclusion Criteria: clinically significant stress urinary incontinence polyuria of more than 3000 ml/24 hrs severe hepatic or renal diseases contraindications to the use of antimuscarinic drugs genitourinary conditions that could cause OAB symptoms such as urinary tract infection, genitourinary malignancy or interstitial cystitis uninvestigated hematuria clinically significant bladder outlet obstruction clinically significant pelvic organ prolapse being on a bladder-training program or having been on electrostimulation therapy two weeks before randomization or intention to start unstable dosages of drugs with anticholinergic side effects any other investigational drug taken up to 2 months prior to randomization pregnancy or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Propiverine hydrochloride<br>* Propiverine hydrochloride 20mg twice a day<br>* Other names: BUP-4;|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Identical placebo twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in mean number of urgency episode |  | 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the patients' perception of urgency |  | 12 weeks of treatment | 
| Change in urgency severity/voids |  | 12 weeks of treatment | 
| Change in sum of urgency severity/24 hours |  | 12 weeks of treatment | 
| Changes in voiding frequency/24hrs, daytime and nocturnal voiding frequency/24 hours |  | 12 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overactive bladder, Propiverin