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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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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

Intervention / Treatment
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* Drug: Propiverine hydrochloride ER (extended release)
* Drug: Propiverine hydrochloride IR (immediate release)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propiverine hydrochloride ER<br>45 mg | Drug: Propiverine hydrochloride ER (extended release)<br>* 45 mg capsule (1x1/d)<br>* Other names: Detrunorm XL 45;|
| Active Comparator: Propiverine hydrochloride IR<br>15 mg | Drug: Propiverine hydrochloride IR (immediate release)<br>* 15 mg tablet (3x1/d)<br>* Other names: Detrunorm;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antimuscarinics, Neurogenic bladder, Propiverine, Urodynamics