Symptomatic Urinary Tract InfectionNCT01477502
Clinical Value of Homeopathic Prophylaxis of Recurrent Urinary Tract Infections in Persons With Spinal Cord Injury
A study testing individual homeopathic treatment and standard treatment without homeopathy in people with Symptomatic Urinary Tract Infection and Spinal Cord Injury, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Symptomatic Urinary Tract Infection, Spinal Cord Injury
- What is being tested?
- individual homeopathic treatment and standard treatment without homeopathy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2011to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- neurogenic bladder dysfunction treated by intermittent catheterization
- recurrent (>3/year) symptomatic urinary tract infections
Who cannot join
- inability to speak German
- already under homeopathic treatment
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic center
Nottwil, Canton of Lucerne, 6207
About this study
Official title: 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
- Being tested
- individual homeopathic treatment, standard treatment without homeopathy
- Keywords
- urinary tract infection, spinal cord injury, homeopathy, prevention
- Medical subject headings
- Spinal Cord Injuries, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individual homeopathic treatmentOther
participants are diagnosed by a trained homeopath and receive individualized homeopathic treatment in addition to standard UTI prophylaxis
standard treatment without homeopathyOther
participants receive standard UTI prophylaxis
| Study group | Role | What they receive |
|---|---|---|
| individual homeopathic treatment | Active comparator | participants receive homeopathic treatment in addition to standard prevention measures for UTI Receives: Other: individual homeopathic treatment |
| standard prophylaxis | Other | Not described Receives: Other: standard treatment without homeopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of symptomatic urinary tract infections
Measured: one year
Secondary outcomes (1)
number of symptomatic urinary tract infections compared to the previous year
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionAug 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jürgen Pannek, MD, Principal investigator, Swiss Paraplegic Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477502
- Sponsor's protocol ID
- 2011-24
- Other IDs
- 11050
- Status last verified
- Feb 2024
- First submitted
- 17 Nov 2011
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29485355
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Value of Homeopathic Assessment and Treatment for Prophylaxis of Recurrent Urinary Tract Infections in Persons With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01477502
- Acronym / sponsor ID
- 2011-24
- Keywords
- urinary tract infection, spinal cord injury, homeopathy, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- Nov 2011
- Primary completion
- Aug 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| individual homeopathic treatment | Active comparator | Other: individual homeopathic treatmentparticipants receive homeopathic treatment in addition to standard prevention measures for UTI |
| standard prophylaxis | Other | Other: standard treatment without homeopathy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- neurogenic bladder dysfunction treated by intermittent catheterization
- recurrent (>3/year) symptomatic urinary tract infections
Key exclusion criteria (2 listed)
- inability to speak German
- already under homeopathic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| individual homeopathic treatmentparticipants are diagnosed by a trained homeopath and receive individualized homeopathic treatment in addition to standard UTI prophylaxis | Other | individual homeopathic treatment |
| standard treatment without homeopathyparticipants receive standard UTI prophylaxis | Other | standard prophylaxis |
Primary outcome
number of symptomatic urinary tract infections
Time frame: one year
1 secondary outcome
number of symptomatic urinary tract infections compared to the previous year
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Derived from this study: PubMed 29485355Pannek 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.
Related trials for Symptomatic Urinary Tract Infection
Active, not recruitingObservational study
Bacteriuria and Indwelling Urinary Catheter.
Bacteriuria Asymptomatic, Urinary Tract Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jürgen Pannek, MD principal investigator
Swiss Paraplegic Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing individual homeopathic treatment and standard treatment without homeopathy in people with Symptomatic Urinary Tract Infection and Spinal Cord Injury, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of symptomatic urinary tract infections (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01477502, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.