- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01477502
Clinical Value of Homeopathic Prophylaxis of Recurrent Urinary Tract Infections in Persons With Spinal Cord Injury
February 9, 2024 updated by: Swiss Paraplegic Research, Nottwil
Clinical Value of Homeopathic Assessment and Treatment for Prophylaxis of Recurrent Urinary Tract Infections in Persons With Spinal Cord Injury
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
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Lucerne
-
Nottwil, Lucerne, Switzerland, 6207
- Swiss Paraplegic Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: individual homeopathic treatment
participants receive homeopathic treatment in addition to standard prevention measures for UTI
|
participants are diagnosed by a trained homeopath and receive individualized homeopathic treatment in addition to standard UTI prophylaxis
|
|
Other: standard prophylaxis
|
participants receive standard UTI prophylaxis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
number of symptomatic urinary tract infections
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
number of symptomatic urinary tract infections compared to the previous year
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jürgen Pannek, MD, Swiss Paraplegic Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
October 1, 2016
Study Registration Dates
First Submitted
November 17, 2011
First Submitted That Met QC Criteria
November 21, 2011
First Posted (Estimated)
November 22, 2011
Study Record Updates
Last Update Posted (Actual)
February 13, 2024
Last Update Submitted That Met QC Criteria
February 9, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Central Nervous System Diseases
- Nervous System Diseases
- Urologic Diseases
- Disease Attributes
- Trauma, Nervous System
- Spinal Cord Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Infections
- Communicable Diseases
- Wounds and Injuries
- Urinary Tract Infections
- Spinal Cord Injuries
Other Study ID Numbers
- 2011-24 (AP HM)
- 11050 (Other Identifier: Ethical committe of the Kanton Lucerne, Switzerland)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.