Urinary Urgency Outcomes Following Propiverine Treatment for an Overactive Bladder

May 14, 2009 updated by: Samsung Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

264

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Propiverine hydrochloride
Propiverine hydrochloride 20mg twice a day
Other Names:
  • BUP-4
Placebo Comparator: 2
Drug: Placebo
Identical placebo twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change in mean number of urgency episode
Time Frame: 12 weeks of treatment
12 weeks of treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

May 14, 2009

First Submitted That Met QC Criteria

May 14, 2009

First Posted (Estimate)

May 15, 2009

Study Record Updates

Last Update Posted (Estimate)

May 15, 2009

Last Update Submitted That Met QC Criteria

May 14, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-01-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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