Urinary Urgency Outcomes Following Propiverine Treatment for an Overactive Bladder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00903045
Recruitment Status : Completed
First Posted : May 15, 2009
Last Update Posted : May 15, 2009
Information provided by:
Samsung Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: Propiverine hydrochloride Drug: Placebo Phase 4

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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)
Study Start Date : January 2005
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Propiverine hydrochloride
Propiverine hydrochloride 20mg twice a day
Other Name: BUP-4
Placebo Comparator: 2 Drug: Placebo
Identical placebo twice a day

Primary Outcome Measures :
  1. Percent change in mean number of urgency episode [ Time Frame: 12 weeks of treatment ]

Secondary Outcome Measures :
  1. Change in the patients' perception of urgency [ Time Frame: 12 weeks of treatment ]
  2. Change in urgency severity/voids [ Time Frame: 12 weeks of treatment ]
  3. Change in sum of urgency severity/24 hours [ Time Frame: 12 weeks of treatment ]
  4. Changes in voiding frequency/24hrs, daytime and nocturnal voiding frequency/24 hours [ Time Frame: 12 weeks of treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00903045

Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Principal Investigator: Kyu-Sung Lee, Ph.D Samsung Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kyu-Sung Lee/Professor, Samsung Medical Center Identifier: NCT00903045     History of Changes
Other Study ID Numbers: 2005-01-08
First Posted: May 15, 2009    Key Record Dates
Last Update Posted: May 15, 2009
Last Verified: May 2009

Keywords provided by Samsung Medical Center:
Overactive bladder

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents