Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01530620
Recruitment Status : Completed
First Posted : February 10, 2012
Last Update Posted : February 10, 2012
Sponsor:
Information provided by (Responsible Party):
APOGEPHA Arzneimittel GmbH

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment 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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2004
Actual Primary Completion Date : June 2005
Actual Study Completion Date : July 2006
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Reflex volume (cystometry) [ Time Frame: three weeks ]
    Change in reflex volume compared to baseline and compared between the two treatment arms


Secondary Outcome Measures :
  1. Leak point pressure [ Time Frame: three weeks ]
    Change in LPP compared to baseline and compared between the two treatment arms

  2. Leak point volume [ Time Frame: three weeks ]
    Change in LPV compared to baseline and compared between the two treatment arms

  3. Maximum detrusor pressure [ Time Frame: three weeks ]
    Change in maximum p det compared to baseline and compared between the two treatment arms

  4. Maximum cystometric capacity [ Time Frame: three weeks ]
    Change in maximum cystometric capacity compared to baseline and compared between the two treatment arms

  5. Bladder compliance [ Time Frame: three weeks ]
    Change in compliance compared to baseline and compared between the two treatment arms

  6. Change in number of incontinence episodes [ Time Frame: three weeks ]
    Change of incontinence episodes compared to baseline and compared between the two treatment arms

  7. State of Well-Being Questionnaire [ Time Frame: three weeks ]
    Change of well-beeing compared to baseline and compared between the two treatment arms

  8. Post void residual volume [ Time Frame: three weeks ]
    Change in PVR compared to baseline and compared between the two treatment arms

  9. Incidence and severity of adverse events [ Time Frame: three weeks ]
    occurrences and intensity of adverse events or withdrawals over the whole treatment period


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530620


Locations
Layout table for location information
Austria
Graz, Austria
Germany
Hagenow, Germany
Romania
Bucharest, Romania
Sponsors and Collaborators
APOGEPHA Arzneimittel GmbH
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: APOGEPHA Arzneimittel GmbH
ClinicalTrials.gov Identifier: NCT01530620    
Other Study ID Numbers: 8405010
First Posted: February 10, 2012    Key Record Dates
Last Update Posted: February 10, 2012
Last Verified: February 2012
Keywords provided by APOGEPHA Arzneimittel GmbH:
Antimuscarinics
Neurogenic bladder
Propiverine
Urodynamics
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Bladder, Neurogenic
Urinary Incontinence
Urologic Diseases
Urinary Bladder, Overactive
Urinary Bladder Diseases
Disease
Pathologic Processes
Urination Disorders
Lower Urinary Tract Symptoms
Urological Manifestations
Neurologic Manifestations
Nervous System Diseases
 Propiverine
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents