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

Phase 3

Completed

• 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
• Interventions: Drug: Propiverine hydrochloride ER (extended release); Drug: Propiverine hydrochloride IR (immediate release)

• Registration Number: NCT01530620
• Lead Sponsor: APOGEPHA Arzneimittel GmbH

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2005-06
• Study Completion: 2006-07
• Status Verified: 2012-02
• Study First Submitted: 2012-02-02
• Study First Submitted QC: 2012-02-09
• Last Update Submitted: 2012-02-09
• Study First Posted: 2012-02-10
• Last Update Posted: 2012-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propiverine hydrochloride ER	Propiverine hydrochloride ER (extended release)	45 mg
Propiverine hydrochloride IR	Propiverine hydrochloride IR (immediate release)	15 mg

Primary Outcome Measures

Name	Time	Method
Reflex volume (cystometry)	three weeks	Change in reflex volume compared to baseline and compared between the two treatment arms

Secondary Outcome Measures

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