Urinary Urgency Outcomes Following Propiverine Treatment for an Overactive Bladder

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00903045
First received: May 14, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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 Intervention Phase
Overactive Bladder
Drug: Propiverine hydrochloride
Drug: Placebo
Phase 4

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Percent change in mean number of urgency episode [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 264
Study Start Date: January 2005
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Placebo

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00903045

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

No publications provided by Samsung Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kyu-Sung Lee/Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00903045     History of Changes
Other Study ID Numbers: 2005-01-08
Study First Received: May 14, 2009
Last Updated: May 14, 2009
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Samsung Medical Center:
Overactive bladder
Propiverin

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

ClinicalTrials.gov processed this record on October 22, 2014