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Bearberry in the Treatment of Cystitis (BRUMI)

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ClinicalTrials.gov Identifier: NCT05055544
Recruitment Status : Not yet recruiting
First Posted : September 24, 2021
Last Update Posted : September 24, 2021
Sponsor:
Information provided by (Responsible Party):
Dezső Csupor, University of Pecs

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cystitis Drug: Fosfomycin Drug: Bearberry Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 504 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a randomized, controlled, double-blinded, two-armed multicentre trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: BeaRberry in the Treatment of Acute UncoMplIcated Cystitis (BRUMI)- Protocol of a Multicentre, Randomized Double-Blind Clinical Trial
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Fosfomycin
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 fosfomycin (3 g) powder dissolved in 75 ml water and 2 placebo tablets t.i.d. for 7 days (group A),
Active Comparator: Bearberry
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 placebo powder dissolved in 75 ml water and 2 bearberry tablets t.i.d. for 7 days (group B).


Outcome Measures
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Primary Outcome Measures :
  1. Change of symptom severity [ Time Frame: The 2 time points at which the measurement is assessed is the time of enrollment, after 7 days of treatment. ]
    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


Secondary Outcome Measures :
  1. Number of patients without significant urine pathogens [ Time Frame: The time point at which the measurement is assessed on day 7. ]
    number of patients with urine with <103 colony forming units (CFU)/ml on day 7

  2. Number of urine pathogens [ Time Frame: The time point at which the measurement is assessed on day 7. ]
    average number of CFU of pathogens (7 days after the start of the therapy) in urine

  3. Frequency and severity of side effects [ Time Frame: The time point at which the measurement is assessed on day 7. ]
    frequency and severity of side effects used a questionnaire

  4. Recurrence of urinary tract infection (UTI) [ Time Frame: The time point at which the measurement is assessed on day 90. ]
    follow-up after 90 days; severity and diagnostics of recurrences to be assessed by using the ACSS

  5. Concurrent use of other medications [ Time Frame: The time point at which the measurement is assessed on day 7. ]
    concurrent use of other over-the-counter (OTC) medications and food supplements that are started taking during the 7 day treatment trial.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • premenopausal adult women
  • diagnosis of acute uncomplicated cystitis (with the symptoms of dysuria, increased frequency, and urgency of urination and lower abdominal pain (suprapubic pain), that is presumed to be confined to the bladder; with no signs or symptoms that suggest an upper tract or systemic infection)
  • a sum-score of of ≥6 for the typical uncomplicated urinary tract infections symptoms (frequency, urgency, painful urination, incomplete emptying, suprapubic pain, and visible hematuria) reported on the Acute Cystitis Symptom Score (ACSS) typical domain and pyuria (10 white blood cells/mm3 in a mid-stream specimen) at day 0

Exclusion Criteria:

  • any renal disease
  • upper urinary tract infection
  • malformations of the urinary tract
  • congenital disorders of the urinary tract
  • catheter use
  • pregnancy
  • breastfeeding
  • self-medication with bearberry or antibiotic use in the last 3 months
  • 5 or more bearberry treatments in the previous year
  • concomitant use of other antibiotics and NSAIDs
  • contraindication for study drugs
  • active malignancy
  • immunodeficiency, including immunosuppressive treatment.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05055544


Locations
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Hungary
Institute for Translational Medicine, University of Pécs
Pécs, Hungary, 7624
Sponsors and Collaborators
University of Pecs
More Information
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Additional Information:

Publications:

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Responsible Party: Dezső Csupor, associate professor, University of Pecs
ClinicalTrials.gov Identifier: NCT05055544    
Other Study ID Numbers: IV/4225-1/2021/EKU
First Posted: September 24, 2021    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
URL: http://tm-centre.org/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dezső Csupor, University of Pecs:
bearberry
cystitis
uncomplicated cystitis
fosfomycin
Additional relevant MeSH terms:
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Cystitis
Urinary Bladder Diseases
Urologic Diseases
 Fosfomycin
Anti-Bacterial Agents
Anti-Infective Agents