Overview

Reducing Antibiotic Use for Uncomplicated Urinary Tract Infection in General Practice by Treatment With Uva Ursi (UU)- a Comparative Effectiveness Trial

Status:
Completed
Trial end date:
2019-06-20
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Medical Center Goettingen
Treatments:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Fosfomycin
Criteria
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