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

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: APOGEPHA Arzneimittel GmbH
• Treatments: Propiverine

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