Clinical trial NCT05545514: Individualized Homeopathy to Reduce the Use of Antibiotics in Women With Recurrent Uncomplicated Urinary Tract Infections
Official title: Individualized Homeopathy to Reduce the Use of Antibiotics in Women With Recurrent Uncomplicated Urinary Tract Infections
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Urinary Tract Infection Chronic
Keywords: Cystitis
Nephritis
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: School of Medicine, Technical University Munich, Münchner Studienzentrum
name: Klinikum rechts der Isar, TUM Institute for AI and Informatics in Medicine (AIIM)
First posted: 2022-09-19
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase IV, monocentric, randomised, double-blind, parallel-group, placebo-controlled clinical trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Females, age 18 \< 64 years
2. Signed informed consent
3. Documented recurrent UTI (i.e. ≥ 2 UTI in 6 months and/ or ≥ 3 UTI in 12 months)
4. No change of other prophylactic treatment (e.g. Urovaxom, oestrogen) for recurrent UTI for at least three months before baseline
5. No product or dosage change of systemic hormonal treatment (including oral anticonception) for at least three months before baseline
6. Female participants who are not capable of bearing children or who use a method of contraception that is medically approved by the health authority of the respective country.

This includes:

* A woman who is not capable of bearing a child is defined as follows: post-menopausal (12 months natural (spontaneous) amenorrhea or 6 months spontaneous amenorrhea with serum-FSH-values (follicle-stimulating hormone) of \>40 mIU/mL); 6 weeks after a bilateral ovariectomy with or without hysterectomy or sterilization by means of tubal ligation
* A woman capable of bearing child is defined as follows: a woman who is physiologically capable of becoming pregnant, including women whose occupation, lifestyle or sexual orientation exclude sexual intercourse with a male partner and women whose partners have been sterilized by vasectomy or other measures.
* Medically-approved methods of contraception can include the following: hormonal contraceptives, intrauterine device and double barrier method. Acceptable preventive measures can include total abstinence at the discretion of the investigator, in cases where compliance is ensured because of the study participant's age, occupation, lifestyle or sexual orientation. Periodical abstinence (e.g. calendar, ovulation, symptothermal methods or abstinence until the 4th day after the ovulation) as well as coitus interruptus are not acceptable methods of contraception.
* A reliable method of contraception must be used for the entire duration of the study.

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

* diseases requiring immune suppressive therapy
* diabetes mellitus type 1 or 2 with an HbA1c \> 7%
* any acute organic failure
* any advanced chronic organic failure (e.g. grade 3 or more)
* active cancer
* active (=clinically unstable) epileptic, cardiovascular or other organic pathology 9. Patients not able to declare meaningful informed consent on their own (e.g. with legal guardian), or other vulnerable patients (e.g. under arrest) 10. Simultaneous participation in any other clinical trial 11. Employees or family members of the sponsor or investigators

Primary outcomes:
measure: ICIQ-FLUTS:
timeFrame: Baseline to month 9
Secondary outcomes:
measure: ICIQ-FLUTS and ACSS
timeFrame: Baseline to 6 month
measure: ICIQ-FLUTS and ACSS
timeFrame: measured between Baseline and month 9
measure: ICIQ-FLUTS and ACCS
timeFrame: measured between Baseline and month 9
measure: SF 12
timeFrame: measured at Baseline and month 9 per visual analogue scale (VAS)
Other outcomes:
Locations:
city: München
country: Germany
facility: Klinikum rechts der Isar, Department of Nephrology
state: Bayern
Study officials:
affiliation: Klinikum rechts der Isar, TUM, Department Nephrology
name: Lutz Renders, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: