Bladder Disorder, Neurogenic, Neurogenic Bladder Disorder, Neurogenic Urinary Bladder Disorder, Overactive Detrusor Function, Urinary Bladder Disorder, Neurogenic, Urinary Bladder, Neurogenic, Urinary Bladder Neurogenic Dysfunction, Urinary Incontinence, Urologic Diseases
Conditions
Keywords
Antimuscarinics, Neurogenic bladder, Propiverine, Urodynamics
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.
Interventions
DRUGPropiverine hydrochloride ER (extended release)
45 mg capsule (1x1/d)
DRUGPropiverine hydrochloride IR (immediate release)
15 mg tablet (3x1/d)
Sponsors
APOGEPHA Arzneimittel GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reflex volume (cystometry) | three weeks | Change in reflex volume compared to baseline and compared between the two treatment arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Leak point volume | three weeks | Change in LPV compared to baseline and compared between the two treatment arms |
| Maximum detrusor pressure | three weeks | Change in maximum p det compared to baseline and compared between the two treatment arms |
| Maximum cystometric capacity | three weeks | Change in maximum cystometric capacity compared to baseline and compared between the two treatment arms |
| Bladder compliance | three weeks | Change in compliance compared to baseline and compared between the two treatment arms |
| Leak point pressure | three weeks | Change in LPP compared to baseline and compared between the two treatment arms |
| State of Well-Being Questionnaire | three weeks | Change of well-beeing compared to baseline and compared between the two treatment arms |
| Post void residual volume | three weeks | Change in PVR compared to baseline and compared between the two treatment arms |
| Incidence and severity of adverse events | three weeks | occurrences and intensity of adverse events or withdrawals over the whole treatment period |
| Change in number of incontinence episodes | three weeks | Change of incontinence episodes compared to baseline and compared between the two treatment arms |
Countries
Austria, Germany, Romania
Outcome results
None listed