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| Name | Class |
|---|---|
| Klinikum rechts der Isar, TUM Institute for AI and Informatics in Medicine (AIIM) | UNKNOWN |
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The aim of the study is to determine the efficacy of individualised homeopathic drug treatment (potency C200 and C1000) compared to placebo in females (age 18<65) with recurrent urinary tract infections, per definition ≥ 2 UTI in 6 months and/ or ≥ 3 UTI in 9 months.
The World Health Organization has declared the problem of antibiotic resistance to be a global crisis and the European Union has defined, among other things, the reduction of antibiotic use in its strategies to avoid the development of resistance. Recurrent UTIs are one of the most common infectious diseases contributing to a multiple of multidrug- resistant extra intestinal pathogenic E coli, increasing morbidity and mortality due to many treatment failures and hospital admissions, which leads to increased healthcare costs. There is, therefore, an urgent need to optimize appropriate usage, in order to minimize the burden of disease for the patients and the health care services, while maintaining treatment safety at the same time.
In Germany, it is currently recommended to treat uncomplicated UTIs symptomatically as long as no dangerous course of the disease can be expected, but different treatment options aiming to decrease the frequency of UTI treated with antibiotics have shown only limited success. Thus, the symptom load of the affected patients as well as prescription rates for antibiotics remain high and treatment options are warranted by patients and physicians.
Homeopathy has shown relevant clinical effects for other recurrent infectious diseases and a reduction of the frequency of recurrent UTIs with individualised homeopathic treatment (iHOM) has been observed in practice. In this study we therefore aim to test the efficacy of this treatment approach as an add-on therapy to the treatment standard in a double-blind, placebo-controlled randomised clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum | Experimental | Individualized homeopathy (iHOM): One out of 140 predefined homeopathic medical products (HMP) in potency C200 or C1000, individually selected as indicated per homeopathic treatment principles. The HMPs are sucrose pillules, impregnated with the specific homeopathic substance and potency and will be administered once at baseline: 5 pillules sublingually. The dosage of the HMP can be repeated or adapted according to the homeopathic treatment principles three times during the course of the study and, in addition, in the event of an acute UTI. |
|
| Placebo | Placebo Comparator | Non-impregnated sucrose pillules, identical to the HMP (verum) in appearance, taste and size. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One out of 140 predefined homeopathic medical products (HMP) in potency C200 or C1000, | Drug | To investigate the efficacy of individualised homeopathic treatment (potency C200 and/or C1000) in comparison to placebo regarding the number of UTI treated with antibiotic agents. |
| Measure | Description | Time Frame |
|---|---|---|
| ICIQ-FLUTS: | To compare the number of UTI treated with antibiotic agents, measured between Baseline and month 9 in both groups A UTI is defined by the criteria of the German S3-guideline for the diagnostic of uncomplicated lower UTI:
The criteria for a prescription of antibiotic agents to the patient are:
| Baseline to month 9 |
| Measure | Description | Time Frame |
|---|---|---|
| ICIQ-FLUTS and ACSS | Time until the first UTI after the start of the study treatment (regardless of treatment of the first UTI) | Baseline to 6 month |
| ICIQ-FLUTS and ACSS | The number of UTI treated with antibiotic agents |
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Inclusion Criteria:
This includes:
Exclusion Criteria:
1. Individual symptomatology of the patient indicates the prescription of a HMP which is not available within this clinical trial 2. Pregnancy or breast feeding after pregnancy 3. Women with a complicated urinary tract infection (including infections occurring due to anatomical abnormalities (e.g. an obstruction, renal tract calculi, hydro nephrosis), infections occurring due to an immune compromised state (e.g. HIV, immune suppressive therapy), and recurrent infections despite adequate treatment (multi-drug resistant organisms or atypical organisms)) 4. Surgery of the urinary tract or the pelvic floor 5. Known hypersensivity against the study medication or the recommended on demand medication (Ibuprofen) 6. Homoeopathic therapy for recurrent UTIs during the last 6 months before baseline 7. Postmenopausal woman WITHOUT previous attempt of a therapy with locally applicate (vaginal) oestrogen 8. Serious acute or chronic organic disease or serious mental disorder, including
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| Name | Affiliation | Role |
|---|---|---|
| Lutz Renders, Prof. Dr. med. | Klinikum rechts der Isar, TUM, Department Nephrology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum rechts der Isar, Department of Nephrology | München | Bavaria | 81675 | Germany |
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Phase IV, monocentric, randomised, double-blind, parallel-group, placebo-controlled clinical trial
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double-blind
|
| measured between Baseline and month 9 |
| ICIQ-FLUTS and ACCS | The number of UTI treated symptomatically | measured between Baseline and month 9 |
| SF 12 | Subjective symptom load and disease-specific quality of life over the last 3 months | measured at Baseline and month 9 per visual analogue scale (VAS) |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D009393 | Nephritis |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D007674 | Kidney Diseases |
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| ID | Term |
|---|---|
| D013649 | Taste |
| ID | Term |
|---|---|
| D012677 | Sensation |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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