The goal of this study is to assess the efficacy of bearberry in uncomplicated cystitis.
Uncomplicated cystitis is a disease related to the infection of the urinary bladder. Typical
symptoms are dysuria, urinary urgency, and frequent voiding of small volumes. Urinary tract
infections are frequent in women, usually treated with antibiotics, since the disease is
usually caused by bacteria.
Fosfomycin is a frequently used antibiotic for the treatment of uncomplicated cystitis. This
medicine is typically prescribed by MDs. However, since uncomplicated cystitis is quite
frequent, not all patients visit the doctor when experiencing the symptoms of this disease.
The use of over-the-counter products (medicines and food supplements) to alleviate the
symptoms is common. One of the most frequently used medicinal plants for this purpose is
bearberry. Bearberry is a medicinal plant traditionally used for the treatment of cystitis.
Its use is accepted by the European Medicine Agency as traditional herbal medicinal product
for relief of symptoms of mild recurrent lower urinary tract infections such as burning
sensation during urination and/or frequent urination in women. Although the experience gained
during the traditional use and the laboratory experiments support the supposed beneficial
effect of bearberry, its clinical efficacy has not been confirmed in well-designed clinical
trials in comparison with standard antibiotic therapy. In this study, the efficacy of
bearberry will be assessed in comparison with fosfomycin.
Premenopausal women experiencing the symptoms of uncomplicated cystitis will be randomly
divided into two groups. Since it will be a double-blind trial, neither the participants nor
the experimenters will know who is receiving a particular treatment. In group A, patients
will receive a single dose of fosfomycin powder dissolved in water and 2 placebo tablets
three times a day for 7 days. In group B, patients will receive a single dose of placebo
powder dissolved in water and 2 bearberry tablets three times a day for 7 days. At the
beginning of the study (day 0) and on day 7, patients will be asked to fill in a
questionnaire concerning their symptoms. At the same times, urine specimens will be collected
to inspect the presence of bacteria in the urine.
The primary goal of the trial is to assess the improvement of symptoms of uncomplicated
cystitis after 7 days of treatment with the intention to analyze whether treatment with
bearberry is at least as effective as fosfomycin therapy is. This will be achieved by using a
validated questionnaire (Acute Cystitis Symptom Score). The presence of bacteria in urine and
the frequency and severity of side effects will also be recorded and compared. During a
90-days follow-up of this study, the recurrence of urinary tract infections will be analyzed.
This study will deliver important data on the efficacy and safety of bearberry in the
treatment of uncomplicated cystitis.