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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01477502
First Posted: November 22, 2011
Last Update Posted: October 13, 2016
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.
Information provided by (Responsible Party):
Clinical Trial Unit, Swiss Paraplegic Centre Nottwil
  Purpose

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

Condition Intervention
Symptomatic Urinary Tract Infection Spinal Cord Injury Other: individual homeopathic treatment Other: standard treatment without homeopathy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Clinical Value of Homeopathic Assessment and Treatment for Prophylaxis of Recurrent Urinary Tract Infections in Persons With Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Clinical Trial Unit, Swiss Paraplegic Centre Nottwil:

Primary Outcome Measures:
  • number of symptomatic urinary tract infections [ Time Frame: one year ]

Secondary Outcome Measures:
  • number of symptomatic urinary tract infections compared to the previous year [ Time Frame: one year ]

Enrollment: 46
Study Start Date: November 2011
Study Completion Date: October 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: individual homeopathic treatment
participants receive homeopathic treatment in addition to standard prevention measures for UTI
Other: individual homeopathic treatment
participants are diagnosed by a trained homeopath and receive individualized homeopathic treatment in addition to standard UTI prophylaxis
standard prophylaxis Other: standard treatment without homeopathy
participants receive standard UTI prophylaxis

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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): NCT01477502


Locations
Switzerland
Swiss Paraplegic center
Nottwil, Lucerne, Switzerland, 6207
Sponsors and Collaborators
Swiss Paraplegic Centre Nottwil
Investigators
Principal Investigator: Jürgen Pannek, MD Swiss Paraplegic Center
  More Information

Responsible Party: Clinical Trial Unit, Professor Jürgen Pannek, Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier: NCT01477502     History of Changes
Other Study ID Numbers: 2011‐24
11050 ( Other Identifier: Ethical committe of the Kanton Lucerne, Switzerland )
First Submitted: November 17, 2011
First Posted: November 22, 2011
Last Update Posted: October 13, 2016
Last Verified: October 2016

Keywords provided by Clinical Trial Unit, Swiss Paraplegic Centre Nottwil:
urinary tract infection
spinal cord injury
homeopathy
prevention

Additional relevant MeSH terms:
Infection
Communicable Diseases
Wounds and Injuries
Spinal Cord Injuries
Urinary Tract Infections
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Urologic Diseases