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

NCT ID: NCT01530620

Last Updated: 2012-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2006-07-31

Brief Summary

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.

Conditions

Neurogenic Urinary Bladder Disorder; Urinary Bladder, Neurogenic; Bladder Disorder, Neurogenic; Urinary Bladder Disorder, Neurogenic; Neurogenic Bladder Disorder; Urinary Bladder Neurogenic Dysfunction; Urologic Diseases; Overactive Detrusor Function; Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Propiverine hydrochloride ER

45 mg

Group Type: EXPERIMENTAL

Propiverine hydrochloride ER (extended release)

Intervention Type: DRUG

45 mg capsule (1x1/d)

Propiverine hydrochloride IR

15 mg

Group Type: ACTIVE_COMPARATOR

Propiverine hydrochloride IR (immediate release)

Intervention Type: DRUG

15 mg tablet (3x1/d)

Interventions

Propiverine hydrochloride ER (extended release)

45 mg capsule (1x1/d)

Intervention Type: DRUG

Propiverine hydrochloride IR (immediate release)

15 mg tablet (3x1/d)

Intervention Type: DRUG

Other Intervention Names

Mictonorm UNO 45; Detrunorm XL 45; Mictonorm; Detrunorm

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

APOGEPHA Arzneimittel GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Graz, , Austria

Hagenow, , Germany

Bucharest, , Romania

Countries

Austria; Germany; Romania

Other Identifiers

8405010

Identifier Type: -

Identifier Source: org_study_id