Trial record 10 of 92 for:    Open Studies | "Urinary Tract Infections"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Swiss Paraplegic Centre Nottwil
Sponsor:
Information provided by (Responsible Party):
Clinical Trial Unit, Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier:
NCT01477502
First received: November 17, 2011
Last updated: May 13, 2014
Last verified: May 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Swiss Paraplegic Centre Nottwil:

Primary Outcome Measures:
  • number of symptomatic urinary tract infections [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of symptomatic urinary tract infections compared to the previous year [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: November 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01477502

Contacts
Contact: Jürgen Pannek, MD 0041 41 939 5922 juergen.pannek@paranet.ch
Contact: Peter Bartel, MD 0041 41 939 5930 peter.bartel@paranet.ch

Locations
Switzerland
Swiss Paraplegic center Recruiting
Nottwil, Lucerne, Switzerland, 6207
Contact: Jürgen Pannek, MD    0041 41 939 ext 5922    juergen.pannek@paranet.ch   
Contact: Peter Bartel, MD    0041 41 939 ext 5930    peter.bartel@paranet.ch   
Principal Investigator: Jürgen Pannek, MD         
Sponsors and Collaborators
Swiss Paraplegic Centre Nottwil
Investigators
Principal Investigator: Jürgen Pannek, MD Swiss Paraplegic Center
  More Information

No publications provided

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
Study First Received: November 17, 2011
Last Updated: May 13, 2014
Health Authority: Switzerland: Ethikkommission

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

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

ClinicalTrials.gov processed this record on July 20, 2014