Efficacy and Tolerability of Propiverine Hydrochloride in Patients With Neurogenic Detrusor Overactivity

Efficacy and Tolerability of Propiverine Hydrochloride Extended Release (ER) Compared to Immediate Release (IR) in Patients With Neurogenic Detrusor Overactivity. A Randomized, Double Blind, Parallel Group, Multicenter Clinical Trial

The purpose of this clinical study is to compare efficacy and safety of propiverine hydrochloride extended and immediate release formulations in patients suffering from neurogenic detrusor overactivity.

Study Overview

• Status: Completed
• Conditions: Urologic Diseases; Urinary Incontinence; Urinary Bladder, Neurogenic; Neurogenic Urinary Bladder Disorder; Bladder Disorder, Neurogenic; Urinary Bladder Disorder, Neurogenic; Neurogenic Bladder Disorder; Urinary Bladder Neurogenic Dysfunction; Overactive Detrusor Function
• Intervention / Treatment: Drug: Propiverine hydrochloride ER (extended release); Drug: Propiverine hydrochloride IR (immediate release)

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
• Germany
  • Hagenow, Germany
• Romania
  • Bucharest, Romania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female Caucasian patients aged ≥18 and ≤70 years
• Voluntarily signed informed consent
• Neurogenic detrusor overactivity with occurrence of reflex detrusor contractions
• Reflex volume of ≤250 mL
• Intact reflex arcs in the area of segments S2-S4

Exclusion Criteria:

• Patients suffering from multiple sclerosis under unstable conditions
• Augmented reflex bladder
• Patients with increased residual urine (≥20 % of the maximum bladder capacity), in whom catheterization is not possible
• Acute urinary tract infection
• Electrostimulation therapy (within 4 weeks propir to Visit 1)
• Anomalies of the lower genitourinary tract (e.g. ectopic ureters, fistulas, urethral stenosis)
• Radiation bladder, interstitial cystitis, bladder calculi, bladder carcinoma
• Surgery of the lower genitourinary tract within the last 6 months (e.g. prostatectomy, hysterectomy, tumor surgery)
• Pre-existing medical contraindications for anticholinergics
• Cardiac insufficiency (NYHA stage III/ IV)
• Therapy with botulinum toxin within the last 12 months
• Evidence of severe renal, hepatic or metabolic disorders
• History of drug or alcohol abuse
• Concomitant medication known to have a potential to interfere with the trial medication
• Known hypersensitivity to Propiverine hydrochloride or excipients contained in the trial medication, respectively
• Pregnant or breast-feeding women, or women of childbearing potential without using any reliable contraceptive method
• Patients with impaired co-operation or who are unable to understand the nature, scope and possible consequences of the study

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Propiverine hydrochloride ER; 45 mg	Drug: Propiverine hydrochloride ER (extended release); 45 mg capsule (1x1/d); Other Names: Mictonorm UNO 45; Detrunorm XL 45
Active Comparator: Propiverine hydrochloride IR; 15 mg	Drug: Propiverine hydrochloride IR (immediate release); 15 mg tablet (3x1/d); Other Names: Mictonorm; Detrunorm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reflex volume (cystometry)	Change in reflex volume compared to baseline and compared between the two treatment arms	three weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leak point pressure	Change in LPP compared to baseline and compared between the two treatment arms	three weeks
Leak point volume	Change in LPV compared to baseline and compared between the two treatment arms	three weeks
Maximum detrusor pressure	Change in maximum p det compared to baseline and compared between the two treatment arms	three weeks
Maximum cystometric capacity	Change in maximum cystometric capacity compared to baseline and compared between the two treatment arms	three weeks
Bladder compliance	Change in compliance compared to baseline and compared between the two treatment arms	three weeks
Change in number of incontinence episodes	Change of incontinence episodes compared to baseline and compared between the two treatment arms	three weeks
State of Well-Being Questionnaire	Change of well-beeing compared to baseline and compared between the two treatment arms	three weeks
Post void residual volume	Change in PVR compared to baseline and compared between the two treatment arms	three weeks
Incidence and severity of adverse events	occurrences and intensity of adverse events or withdrawals over the whole treatment period	three weeks

Collaborators and Investigators

• Sponsor: APOGEPHA Arzneimittel GmbH

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): June 1, 2005
• Study Completion (Actual): July 1, 2006

Study Registration Dates

• First Submitted: February 2, 2012
• First Submitted That Met QC Criteria: February 9, 2012
• First Posted (Estimate): February 10, 2012

Study Record Updates

• Last Update Posted (Estimate): February 10, 2012
• Last Update Submitted That Met QC Criteria: February 9, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Urodynamics; Antimuscarinics; Neurogenic bladder; Propiverine
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Neurologic Manifestations; Urination Disorders; Urinary Bladder, Overactive; Disease; Urinary Incontinence; Urinary Bladder, Neurogenic; Urologic Diseases; Urinary Bladder Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Propiverine
• Other Study ID Numbers: 8405010