Urinary Tract Infections
Conditions
Keywords
Uva Ursi, fosfomycin, uncomplicated urinary tract infection of women
Brief summary
It is well known that over-treatment of straightforward infections should be avoided as far as possible. Evidence-based data on non antibiotic treatment options for common conditions are therefore needed urgently. This randomised-controlled double blind trial examines whether initial herbal treatment with Uva Ursi, and antibiotic treatment only if symptoms persist, reduces antibiotic consumption in uncomplicated urinary tract infections (UTI) without a negative effect on symptom course and rate of recurrent UTIs. In total, 430 patients presenting with typical UTI symptoms will be included by their GPs and receive randomised either herbal treatment with uva ursi (antibiotics only if symptoms persist), or initial antibiotic treatment. Patients record symptom severity and drug intake in a diary and complete a final questionnaire after 28 days.
Interventions
DRUGArctuvan
application of a herbal drug
DRUGFosfomycin
application of an antibiotic drug
application of Placebo to Arctuvan
application of Placebo to Fosfomycin
Sponsors
University Medical Center Goettingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Women (18-75 years) with suspected UTI * at least two symptoms of UTI (dysuria, urgency of micturition, frequency, lower abdominal pain) * Written informed consent
Exclusion criteria
* signs of complicated UTI (e. g. temperature \> 38°C, loin tenderness) * conditions that may lead to complicated infections (i.e. renal diseases, patients with urinary catheter) * pregnancy/ breastfeeding * current self-medication with UU preparations e.g. z.B. Cystinol®, Uvalysat®, Arctuvan® * antibiotic use in the last 7 days * previous UTI in the past 2 weeks * history of pyelonephritis * contraindications for trial drugs * serious diseases * inability to understand trial Information * current participation in another clinical trial or participation in another clinical trial within the last 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| antibiotic courses | day 0-28 | number of antibiotic courses from day 0 to day 28 |
| symptom burden | day 0-7 | symptom burden (AUC) from day 0 to day 7 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| patients with poor outcome: worsening symptoms | day 28 | number of patients with worsening symptoms (impairment in symptom score) |
| early relapses | day 0-14 | number of early relapses until day 14 |
| recurrent UTI | day 15-28 | number of recurrent UTI day 15-28 |
| symptom resolution | day 4 and 7 | number of patients with symptom resolution on day 4/7 |
| symptom sum score by patients' questionnaire | day 0-7 | mean daily symptom sum scores from day 0 to day 7; Each of the symptoms dysuria, urgency, frequency and lower abdominal pain is scored daily on a five point scale from 0 none to 4 very strong in a patients' questionnaire. |
| symptom burden for dysuria | day 0-7 | symptom burden (AUC) for dysuria scored daily on a five point scale from 0 none to 4 very strong, from day 0 to day 7 |
| symptom burden positive urine culture | day 0-7 | symptom burden (AUC) day 0-7 of patients with positive urine culture |
| symptom burden negative urine culture | day 0-7 | symptom burden (AUC) day 0-7 of patients with negative urine culture |
| activity impairment by UTI symptoms, measured as AUC | day 0-7 | activity impairment by UTI symptoms (days 0-7), measured as AUC. Impairment by each UTI symptom is scored daily on a five point scale from 0 none to 4 very strong. |
| painkillers | day 0-7 | use of painkillers (Defined Daily Dose (DDD) day 0-7) |
| UTI related sick leave | day 0-28 | number of days of UTI related sick leave day 0-28 |
| antibiotic use | day 0-28 | antibiotic use (defined daily dose (DDD) day 0-28) |
| UTI related visits | day 0-28 | number of UTI related visits day 0-28 |
| patients with poor outcome: prolonged symptoms | day 0-28 | number of patients with prolonged symptoms (\> 7 days), day 0-28. Patients will be followed up until symptom resolution, defined as max. 1 score point on each symptom scale. |
| pyelonephritis | day 0-28 | number of pyelonephritis day 0-28, according to GP´s diagnosis |
| AE and SAE | day 0-28 | number of AE and SAE by system organ class day 0-28 |
| patients with at least 1 AE/ 2 AE | day 28 | proportion of patients with at least 1 AE/ 2 AE |
| symptom burden for urgency | day 0-7 | symptom burden (AUC) for urgency scored daily on a five point scale from 0 none to 4 very strong, from day 0 to day 7 |
| symptom burden for frequency | day 0-7 | symptom burden (AUC) for frequency scored daily on a five point scale from 0 none to 4 very strong, from day 0 to day 7 |
| symptom burden for lower abdominal pain | day 0-7 | symptom burden (AUC) for lower abdominal pain scored daily on a five point scale from 0 none to 4 very strong, from day 0 to day 7 |
| patients taking painkillers | day 28 | number of patients taking painkillers |
| patients with poor outcome: temperature | day 0-7 | number of patients with temperature \>38°C, day 0-7, according to patients´ statement |
Countries
Germany
Outcome results
None listed