An interventional study of Fosfomycin and Bearberry in Cystitis, sponsored by University of Pecs. Not yet recruiting at 1 site in Hungary. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2021-09-24.
Sponsored by University of Pecs · Not applicable, Interventional, and Treatment
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.
This randomized, controlled double-blind multicentre trial will assess the non-inferiority of bearberry (Arctostaphylos uva-ursi) in comparison with fosfomycin in the therapy of uncomplicated cystitis.
In clinical practice, acute uncomplicated cystitis is usually treated based on the clinical signs and symptoms. According to current guidelines, first-line drugs are fosfomycin trometamol, nitrofurantoin, nitroxoline, trimethoprim-sulfamethoxazole, and pivmecillinam. The advantage of fosfomycin is that a single is considered to be sufficient for the treatment of uncomplicated cystitis, resulting in better patient compliance compared to other antibiotics.
Bacterial resistance is one of the major drawback of antibiotic use. Therefore, the assessment of other medicines than currently used antibiotics is of primary importance. One of the most widely used over-the-counter medications in the treatment of urinary tract infection-related symptoms is bearberry. Although this plant has been used in traditional medicine for the treatment of acute cystitis, and the European Medicines Agency acknowledged its use as traditional herbal medicinal product used for the treatment of symptoms of mild recurrent lower urinary tract infections such as burning sensation during urination and/or frequent urination in women, the efficacy has not been assessed in well-designed clinical trials. Since several patients are using bearberry-based medicines, it is important to obtain clinical data on the efficacy and safety of this plant. The aim of this study is to assess the non-inferiority of bearberry in comparison with a standard antibiotic (fosfomycin) used in acute uncomplicated cystitis.
69 studies on the registry are indexed under Cystitis; 17 are open to participants now.
This study's planned enrollment of 504 is above the median of 112 across 50 interventional studies indexed under Cystitis.
Browse Cystitis studies →University of Pecs is the lead sponsor of 106 studies on the registry; 25 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
a single dose of fosfomycin (3 g) powder dissolved in 75 ml water and 2 placebo tablets t.i.d. for 7 days (group A)
Drug: Fosfomycin
a single dose of placebo powder dissolved in 75 ml water and 2 bearberry tablets t.i.d. for 7 days (group B).
Drug: Bearberry
a single dose of fosfomycin (3 g) powder dissolved in 75 ml water and 2 placebo tablets t.i.d. for 7 days (group A),
a single dose of placebo powder dissolved in 75 ml water and 2 bearberry tablets t.i.d. for 7 days (group B).
Change of symptom severity
the change of symptom severity of uncomplicated cystitis after 7 days of treatment. The improvement of symptoms will be determined by using the validated Hungarian version of the Acute Cystitis Symptom Score on day 0 and day 7 according to predefined thresholds
Time frame: The 2 time points at which the measurement is assessed is the time of enrollment, after 7 days of treatment.
Number of patients without significant urine pathogens
number of patients with urine with \<103 colony forming units (CFU)/ml on day 7
Time frame: The time point at which the measurement is assessed on day 7.
Number of urine pathogens
average number of CFU of pathogens (7 days after the start of the therapy) in urine
Time frame: The time point at which the measurement is assessed on day 7.
Frequency and severity of side effects
frequency and severity of side effects used a questionnaire
Time frame: The time point at which the measurement is assessed on day 7.
Recurrence of urinary tract infection (UTI)
follow-up after 90 days; severity and diagnostics of recurrences to be assessed by using the ACSS
Time frame: The time point at which the measurement is assessed on day 90.
Concurrent use of other medications
concurrent use of other over-the-counter (OTC) medications and food supplements that are started taking during the 7 day treatment trial.
Time frame: The time point at which the measurement is assessed on day 7.
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Data sharing details ↗ · tm-centre.org
Start is estimated for Oct 2021; primary completion for Oct 2025, 48 months later.
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This study is not yet recruiting, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fosfomycin