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Clinical Value of Homeopathic Prophylaxis of Recurrent Urinary Tract Infections in Persons With Spinal Cord Injury

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: NCT01477502
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : October 13, 2016
Sponsor:
Information provided by (Responsible Party):
Clinical Trial Unit, Swiss Paraplegic Centre Nottwil

Tracking Information
First Submitted Date  ICMJE November 17, 2011
First Posted Date  ICMJE November 22, 2011
Last Update Posted Date October 13, 2016
Study Start Date  ICMJE November 2011
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2011)
number of symptomatic urinary tract infections [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2011)
number of symptomatic urinary tract infections compared to the previous year [ Time Frame: one year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Value of Homeopathic Prophylaxis of Recurrent Urinary Tract Infections in Persons With Spinal Cord Injury
Official Title  ICMJE Clinical Value of Homeopathic Assessment and Treatment for Prophylaxis of Recurrent Urinary Tract Infections in Persons With Spinal Cord Injury
Brief Summary

recurrent symptomatic urinary tracts infections (UTI) in persons with spinal cord injury are a frequent problem, leading to significant morbidity and to a decreased quality of life.

  • until today, there is no effective prophylaxis for UTI for patients with spinal cord injury.
  • homeopathy has been shown to be an effective treatment option in several chronic diseases
  • study hypothesis: the addition of homeopathic assessment and treatment to a standard prevention strategy for recurrent UTI will significantly reduce the number of symptomatic UTI per year in this group of patients compared to standard prevention alone
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Symptomatic Urinary Tract Infection
  • Spinal Cord Injury
Intervention  ICMJE
  • Other: individual homeopathic treatment
    participants are diagnosed by a trained homeopath and receive individualized homeopathic treatment in addition to standard UTI prophylaxis
  • Other: standard treatment without homeopathy
    participants receive standard UTI prophylaxis
Study Arms  ICMJE
  • Active Comparator: individual homeopathic treatment
    participants receive homeopathic treatment in addition to standard prevention measures for UTI
    Intervention: Other: individual homeopathic treatment
  • standard prophylaxis
    Intervention: Other: standard treatment without homeopathy
Publications * Pannek J, Pannek-Rademacher S, Jus MS, Wöllner J, Krebs J. Usefulness of classical homeopathy for the prophylaxis of recurrent urinary tract infections in individuals with chronic neurogenic lower urinary tract dysfunction. J Spinal Cord Med. 2019 Jul;42(4):453-459. doi: 10.1080/10790268.2018.1440692. Epub 2018 Feb 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 1, 2015)
46
Original Estimated Enrollment  ICMJE
 (submitted: November 21, 2011)
50
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • neurogenic bladder dysfunction treated by intermittent catheterization
  • recurrent (>3/year) symptomatic urinary tract infections

Exclusion Criteria:

  • inability to speak German
  • already under homeopathic treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01477502
Other Study ID Numbers  ICMJE 2011‐24
11050 ( Other Identifier: Ethical committe of the Kanton Lucerne, Switzerland )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clinical Trial Unit, Swiss Paraplegic Centre Nottwil
Study Sponsor  ICMJE Swiss Paraplegic Centre Nottwil
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jürgen Pannek, MD Swiss Paraplegic Center
PRS Account Swiss Paraplegic Centre Nottwil
Verification Date October 2016

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