NCT01477502

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

4.8 years

First QC Date

November 17, 2011

Last Update Submit

February 9, 2024

Conditions

Keywords

urinary tract infectionspinal cord injuryhomeopathyprevention

Outcome Measures

Primary Outcomes (1)

  • number of symptomatic urinary tract infections

    one year

Secondary Outcomes (1)

  • number of symptomatic urinary tract infections compared to the previous year

    one year

Study Arms (2)

individual homeopathic treatment

ACTIVE COMPARATOR

participants receive homeopathic treatment in addition to standard prevention measures for UTI

Other: individual homeopathic treatment

standard prophylaxis

OTHER
Other: standard treatment without homeopathy

Interventions

participants are diagnosed by a trained homeopath and receive individualized homeopathic treatment in addition to standard UTI prophylaxis

individual homeopathic treatment

participants receive standard UTI prophylaxis

standard prophylaxis

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • inability to speak German
  • already under homeopathic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Paraplegic center

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Spinal Cord InjuriesUrinary Tract Infections

Interventions

Homeopathy

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesInfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Jürgen Pannek, MD

    Swiss Paraplegic Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2011

First Posted

November 22, 2011

Study Start

November 1, 2011

Primary Completion

August 1, 2016

Study Completion

October 1, 2016

Last Updated

February 13, 2024

Record last verified: 2024-02

Locations