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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
APOGEPHA Arzneimittel GmbH
ClinicalTrials.gov Identifier:
NCT01530620
First received: February 2, 2012
Last updated: February 9, 2012
Last verified: February 2012

February 2, 2012
February 9, 2012
December 2004
June 2005   (final data collection date for primary outcome measure)
Reflex volume (cystometry) [ Time Frame: three weeks ] [ Designated as safety issue: No ]
Change in reflex volume compared to baseline and compared between the two treatment arms
Same as current
Complete list of historical versions of study NCT01530620 on ClinicalTrials.gov Archive Site
  • Leak point pressure [ Time Frame: three weeks ] [ Designated as safety issue: No ]
    Change in LPP compared to baseline and compared between the two treatment arms
  • Leak point volume [ Time Frame: three weeks ] [ Designated as safety issue: No ]
    Change in LPV compared to baseline and compared between the two treatment arms
  • Maximum detrusor pressure [ Time Frame: three weeks ] [ Designated as safety issue: No ]
    Change in maximum p det compared to baseline and compared between the two treatment arms
  • Maximum cystometric capacity [ Time Frame: three weeks ] [ Designated as safety issue: No ]
    Change in maximum cystometric capacity compared to baseline and compared between the two treatment arms
  • Bladder compliance [ Time Frame: three weeks ] [ Designated as safety issue: No ]
    Change in compliance compared to baseline and compared between the two treatment arms
  • Change in number of incontinence episodes [ Time Frame: three weeks ] [ Designated as safety issue: No ]
    Change of incontinence episodes compared to baseline and compared between the two treatment arms
  • State of Well-Being Questionnaire [ Time Frame: three weeks ] [ Designated as safety issue: No ]
    Change of well-beeing compared to baseline and compared between the two treatment arms
  • Post void residual volume [ Time Frame: three weeks ] [ Designated as safety issue: Yes ]
    Change in PVR compared to baseline and compared between the two treatment arms
  • Incidence and severity of adverse events [ Time Frame: three weeks ] [ Designated as safety issue: Yes ]
    occurrences and intensity of adverse events or withdrawals over the whole treatment period
Same as current
Not Provided
Not Provided
 
Efficacy and Tolerability of Propiverine Hydrochloride in Patients With Neurogenic Detrusor Overactivity
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • 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
  • Drug: Propiverine hydrochloride ER (extended release)
    45 mg capsule (1x1/d)
    Other Names:
    • Mictonorm UNO 45
    • Detrunorm XL 45
  • Drug: Propiverine hydrochloride IR (immediate release)
    15 mg tablet (3x1/d)
    Other Names:
    • Mictonorm
    • Detrunorm
  • Experimental: Propiverine hydrochloride ER
    45 mg
    Intervention: Drug: Propiverine hydrochloride ER (extended release)
  • Active Comparator: Propiverine hydrochloride IR
    15 mg
    Intervention: Drug: Propiverine hydrochloride IR (immediate release)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
July 2006
June 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany,   Romania
 
NCT01530620
8405010
No
APOGEPHA Arzneimittel GmbH
APOGEPHA Arzneimittel GmbH
Not Provided
Not Provided
APOGEPHA Arzneimittel GmbH
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP