Back to resultsClinical Value of Homeopathic Prophylaxis of Recurrent Urinary Tract Infections in Persons With Spinal Cord Injury
Primary Purpose
Symptomatic Urinary Tract Infection, Spinal Cord Injury
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
individual homeopathic treatment
standard treatment without homeopathy
Sponsored by
About this trial
This is an interventional prevention trial for Symptomatic Urinary Tract Infection focused on measuring urinary tract infection, spinal cord injury, homeopathy, prevention
Eligibility Criteria
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
Sites / Locations
- Swiss Paraplegic center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
individual homeopathic treatment
standard prophylaxis
Arm Description
participants receive homeopathic treatment in addition to standard prevention measures for UTI
Outcomes
Primary Outcome Measures
number of symptomatic urinary tract infections
Secondary Outcome Measures
number of symptomatic urinary tract infections compared to the previous year
Full Information
NCT ID
NCT01477502
First Posted
November 17, 2011
Last Updated
October 12, 2016
Sponsor
Swiss Paraplegic Research, Nottwil
1. Study Identification
Unique Protocol Identification Number
NCT01477502
Brief Title
Clinical Value of Homeopathic Prophylaxis of Recurrent Urinary Tract Infections in Persons With Spinal Cord Injury
Official Title
Clinical Value of Homeopathic Assessment and Treatment for Prophylaxis of Recurrent Urinary Tract Infections in Persons With Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Swiss Paraplegic Research, Nottwil
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Urinary Tract Infection, Spinal Cord Injury
Keywords
urinary tract infection, spinal cord injury, homeopathy, prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
individual homeopathic treatment
Arm Type
Active Comparator
Arm Description
participants receive homeopathic treatment in addition to standard prevention measures for UTI
Arm Title
standard prophylaxis
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
individual homeopathic treatment
Intervention Description
participants are diagnosed by a trained homeopath and receive individualized homeopathic treatment in addition to standard UTI prophylaxis
Intervention Type
Other
Intervention Name(s)
standard treatment without homeopathy
Intervention Description
participants receive standard UTI prophylaxis
Primary Outcome Measure Information:
Title
number of symptomatic urinary tract infections
Time Frame
one year
Secondary Outcome Measure Information:
Title
number of symptomatic urinary tract infections compared to the previous year
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jürgen Pannek, MD
Organizational Affiliation
Swiss Paraplegic Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swiss Paraplegic center
City
Nottwil
State/Province
Lucerne
ZIP/Postal Code
6207
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
29485355
Citation
Pannek J, Pannek-Rademacher S, Jus MS, Wollner 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.
Results Reference
derived
Learn more about this trial
Clinical Value of Homeopathic Prophylaxis of Recurrent Urinary Tract Infections in Persons With Spinal Cord Injury
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