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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
History of Changes
  Purpose

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.


Condition Intervention Phase
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)
Drug: Propiverine hydrochloride IR (immediate release)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by APOGEPHA Arzneimittel GmbH:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 66
Study Start Date: December 2004
Study Completion Date: July 2006
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Propiverine hydrochloride ER
45 mg
 Drug: Propiverine hydrochloride ER (extended release)
45 mg capsule (1x1/d)
Other Names:
  • Mictonorm UNO 45
  • Detrunorm XL 45
Active Comparator: Propiverine hydrochloride IR
15 mg
 Drug: Propiverine hydrochloride IR (immediate release)
15 mg tablet (3x1/d)
Other Names:
  • Mictonorm
  • Detrunorm

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01530620

Locations
Austria
Graz, Austria
Germany
Hagenow, Germany
Romania
Bucharest, Romania
Sponsors and Collaborators
APOGEPHA Arzneimittel GmbH
  More Information

No publications provided

Responsible Party: APOGEPHA Arzneimittel GmbH
ClinicalTrials.gov Identifier: NCT01530620     History of Changes
Other Study ID Numbers: 8405010
Study First Received: February 2, 2012
Last Updated: February 9, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Agency for Health and Food Safety
Romania: National Medicines Agency

Keywords provided by APOGEPHA Arzneimittel GmbH:
Antimuscarinics
Neurogenic bladder
Propiverine
Urodynamics

Additional relevant MeSH terms:
Urinary Bladder Diseases
Urinary Bladder, Neurogenic
Urinary Incontinence
Urologic Diseases
Urinary Bladder, Overactive
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Urination Disorders
Urological Manifestations
 Propiverine
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013