Efficacy and Tolerability of Propiverine Hydrochloride in Patients With Neurogenic Detrusor Overactivity
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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.
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
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Ages Eligible for Study:
18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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)