Urinary Urgency Outcomes Following Propiverine Treatment for an Overactive Bladder

NCT00903045 | Completed Phase 4 DMC

• 1 other identifier: 2005-01-08
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder

Keywords

Overactive bladder; Propiverin

Outcome Measures

Primary Outcomes (1)

• Percent change in mean number of urgency episode

  12 weeks of treatment

Secondary Outcomes (4)

• 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

Study Arms (2)

1

EXPERIMENTAL

Drug: Propiverine hydrochloride

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Propiverine hydrochloride DRUG

Propiverine hydrochloride 20mg twice a day

Also known as: BUP-4

1

Placebo DRUG

Identical placebo twice a day

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years
• Overactive bladder for at least 3 months
• day- voiding diary
• average urinary frequency ≥ 10 voids/24hrs
• urgency ≥ 2 episodes/24hrs
• "moderate to severe" in the Indevus Urgency Severity Scale (IUSS)

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (2)

• Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.

  PMID: 37160401 DERIVED

• Lee KS, Lee HW, Choo MS, Paick JS, Lee JG, Seo JT, Lee JZ, Lee YS, Yoon H, Park CH, Na YG, Jeong YB, Lee JB, Park WH. Urinary urgency outcomes after propiverine treatment for an overactive bladder: the 'Propiverine study on overactive bladder including urgency data'. BJU Int. 2010 Jun;105(11):1565-70. doi: 10.1111/j.1464-410X.2009.09050.x. Epub 2009 Nov 12.

  PMID: 19912183 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

propiverine

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kyu-Sung Lee, Ph.D

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 14, 2009
• First Posted: May 15, 2009
• Study Start: January 1, 2005
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: May 15, 2009

Record last verified: 2009-05

Locations

KR (1)