Women with recurring uncomplicated urinary tract infections MedDRA version: 20.0 Level: LLT Classification code 10021872 Term: Infection urinary tract System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: homeopathic medical products
Pharmaceutical Form: Pillules in single-dose container
Pharmaceutical form of the placebo: Pillules in single-dose container
Route of administration of the pl
Sponsors
Klinikum rechts der Isar, Technische Universität München
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Females, age =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
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 3 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: To investigate the efficacy of prophylactic individualised homeopathic treatment (potency C200 and/or C1000), as a therapeutic principle, in comparison to placebo regarding the number of UTI treated with antibiotic agents. ;Secondary Objective: Seconary Objectives:To investigate the efficacy of individualised homeopathic treatment (potency C200 and/or C1000) in comparison to placebo regarding the number of UTI. To investigate the efficacy of individualised homeopathic treatment (potency C200 and/or C1000) in comparison to placebo regarding the disease-specific quality of life.;Primary end point(s): Primary Endpoint: 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;Timepoint(s) of evaluation of this end point: Measured between months 0-9 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints (comparisons between groups): 1.Time until the first UTI after the start of the study treatment (regardless of treatment of the first UTI) 2.The number of UTI treated symptomatically, measured between Baseline and month 9 3.Subjective symptom load and disease-specific quality of life over the last 3 months, measured at baseline and at month 9 per visual analogue scale (VAS) ;Timepoint(s) of evaluation of this end point: Measured between months 0-9 | — |
Countries
Germany
Contacts
Public ContactProf. Dr. med. Lutz Renders
Klinikum rechts der Isar, Technische Universität München, Abteilung für Nephrologie
Outcome results
None listed