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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
220
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.
Klinikum rechts der Isar, Department of Nephrology
München, Bavaria, Germany
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: 1. Clinical symptoms (either dysuria or increased urinary frequency or increased incontinence or pelvic pain) plus \> 103 bacteria as monoculture in the urine culture, or 2. Clinical symptoms plus urine test-strip with an evidence of nitrite and / or leukocyte-esterase and/ or blood The criteria for a prescription of antibiotic agents to the patient are: 1. Fever \> 38.0 degree Celsius, and / or 2. Persistent pain under symptomatic therapy with Ibuprofen, not tolerated by the patient, and / or 3. Clinical suspicion of pyelonephritis
Time frame: Baseline to month 9
ICIQ-FLUTS and ACSS
Time until the first UTI after the start of the study treatment (regardless of treatment of the first UTI)
Time frame: Baseline to 6 month
ICIQ-FLUTS and ACSS
The number of UTI treated with antibiotic agents
Time frame: measured between Baseline and month 9
ICIQ-FLUTS and ACCS
The number of UTI treated symptomatically
Time frame: measured between Baseline and month 9
SF 12
Subjective symptom load and disease-specific quality of life over the last 3 months
Time frame: measured at Baseline and month 9 per visual analogue scale (VAS)
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