Individualized Homeopathy to Reduce the Use of Antibiotics in Women With Recurrent Uncomplicated Urinary Tract Infections

NCT05545514 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: IHO-0000-REN-0220-S
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infection Chronic

Keywords

Cystitis; Nephritis

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline to month 9

Secondary Outcomes (4)

• ICIQ-FLUTS and ACSS

  Baseline to 6 month

• ICIQ-FLUTS and ACSS

  measured between Baseline and month 9

• ICIQ-FLUTS and ACCS

  measured between Baseline and month 9

• SF 12

  measured at Baseline and month 9 per visual analogue scale (VAS)

Study Arms (2)

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.

Drug: One out of 140 predefined homeopathic medical products (HMP) in potency C200 or C1000,

Placebo

PLACEBO COMPARATOR

Non-impregnated sucrose pillules, identical to the HMP (verum) in appearance, taste and size.

Drug: One out of 140 predefined homeopathic medical products (HMP) in potency C200 or C1000,

Interventions

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.

Also known as: Placebo, Non-impregnated sucrose pillules, identical to the HMP (verum) in appearance, taste and size.

Placebo; Verum

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females, age 18 \< 64 years
• Signed informed consent
• Documented recurrent UTI (i.e. ≥ 2 UTI in 6 months and/ or ≥ 3 UTI in 12 months)
• No change of other prophylactic treatment (e.g. Urovaxom, oestrogen) for recurrent UTI for at least three months before baseline
• No product or dosage change of systemic hormonal treatment (including oral anticonception) for at least three months before baseline
• 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.

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Technical University of Munich: lead
• School of Medicine, Technical University Munich, Münchner Studienzentrum: collaborator
• Klinikum rechts der Isar, TUM Institute for AI and Informatics in Medicine (AIIM): collaborator

Study Sites (1)

Klinikum rechts der Isar, Department of Nephrology

München, Bavaria, 81675, Germany

Location

MeSH Terms

Conditions

Cystitis; Nephritis

Interventions

Taste

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases

Intervention Hierarchy (Ancestors)

Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lutz Renders, Prof. Dr. med.

  Klinikum rechts der Isar, TUM, Department Nephrology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase IV, monocentric, randomised, double-blind, parallel-group, placebo-controlled clinical trial

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 19, 2022
• Study Start: March 15, 2023
• Primary Completion: January 30, 2025
• Study Completion: January 31, 2026
• Last Updated: November 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)