NCT01530620CompletedPhase 3
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
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- APOGEPHA Arzneimittel GmbH
- Enrollment
- 66
- Primary Endpoint
- Reflex volume (cystometry)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Propiverine hydrochloride ER
Experimental
45 mg
Intervention: Propiverine hydrochloride ER (extended release) (Drug)
Propiverine hydrochloride IR
Active Comparator
15 mg
Intervention: Propiverine hydrochloride IR (immediate release) (Drug)
Outcomes
Primary Outcomes
Reflex volume (cystometry)
Time Frame: three weeks
Change in reflex volume compared to baseline and compared between the two treatment arms
Secondary Outcomes
- Maximum cystometric capacity(three weeks)
- Leak point pressure(three weeks)
- Leak point volume(three weeks)
- Maximum detrusor pressure(three weeks)
- Bladder compliance(three weeks)
- Change in number of incontinence episodes(three weeks)
- State of Well-Being Questionnaire(three weeks)
- Post void residual volume(three weeks)
- Incidence and severity of adverse events(three weeks)
Investigators
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