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OpenTrials
Completed

NCT Number: NCT00903045

Urinary Urgency Outcomes Following Propiverine Treatment for an Overactive Bladder

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propiverine hydrochloride

Drug

Propiverine hydrochloride 20mg twice a day

Other names: BUP-4

Placebo

Drug

Identical placebo twice a day

Primary outcomes

  1. Percent change in mean number of urgency episode

    Time frame: 12 weeks of treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
May 15, 2009
Registry last updated
May 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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