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

Apogepha

Status and phase

Completed

Phase 3

Conditions

Urinary Bladder Neurogenic Dysfunction

Urinary Bladder Disorder, Neurogenic

Urinary Bladder, Neurogenic

Bladder Disorder, Neurogenic

Neurogenic Urinary Bladder Disorder

Urinary Incontinence

Neurogenic Bladder Disorder

Urologic Diseases

Overactive Detrusor Function

Treatments

Drug: Propiverine hydrochloride ER (extended release)

Drug: Propiverine hydrochloride IR (immediate release)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01530620

8405010

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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