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

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