Clinical trial NCT01530620: Efficacy and Tolerability of Propiverine Hydrochloride in Patients With Neurogenic Detrusor Overactivity
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neurogenic Urinary Bladder Disorder
Urinary Bladder, Neurogenic
Bladder Disorder, Neurogenic
Urinary Bladder Disorder, Neurogenic
Neurogenic Bladder Disorder
Urinary Bladder Neurogenic Dysfunction
Urologic Diseases
Overactive Detrusor Function
Urinary Incontinence
Keywords: Antimuscarinics
Neurogenic bladder
Propiverine
Urodynamics
Lead sponsor: APOGEPHA Arzneimittel GmbH
Sponsor class: INDUSTRY
First posted: 2012-02-10
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Reflex volume (cystometry)
timeFrame: three weeks
Secondary outcomes:
measure: Leak point pressure
timeFrame: three weeks
measure: Leak point volume
timeFrame: three weeks
measure: Maximum detrusor pressure
timeFrame: three weeks
measure: Maximum cystometric capacity
timeFrame: three weeks
measure: Bladder compliance
timeFrame: three weeks
measure: Change in number of incontinence episodes
timeFrame: three weeks
measure: State of Well-Being Questionnaire
timeFrame: three weeks
measure: Post void residual volume
timeFrame: three weeks
measure: Incidence and severity of adverse events
timeFrame: three weeks
Other outcomes:
Locations:
city: Graz
country: Austria
city: Hagenow
country: Germany
city: Bucharest
country: Romania
Study officials:
References: