Bearberry in the Treatment of Cystitis

NCT05055544 | Unknown DMC

• 1 other identifier: IV/4225-1/2021/EKU
• Study Type: interventional
• Target: 504
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystitis

Keywords

bearberry; cystitis; uncomplicated cystitis; fosfomycin

Outcome Measures

Primary Outcomes (1)

• 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

  The 2 time points at which the measurement is assessed is the time of enrollment, after 7 days of treatment.

Secondary Outcomes (5)

• Number of patients without significant urine pathogens

  The time point at which the measurement is assessed on day 7.

• Number of urine pathogens

  The time point at which the measurement is assessed on day 7.

• Frequency and severity of side effects

  The time point at which the measurement is assessed on day 7.

• Recurrence of urinary tract infection (UTI)

  The time point at which the measurement is assessed on day 90.

• Concurrent use of other medications

  The time point at which the measurement is assessed on day 7.

Study Arms (2)

Fosfomycin

ACTIVE COMPARATOR

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

Bearberry

ACTIVE COMPARATOR

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

Interventions

Fosfomycin DRUG

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),

Fosfomycin

Bearberry DRUG

a single dose of placebo powder dissolved in 75 ml water and 2 bearberry tablets t.i.d. for 7 days (group B).

Bearberry

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (1)

Institute for Translational Medicine, University of Pécs

Pécs, 7624, Hungary

Location

Related Publications (21)

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  PMID: 35750460 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Cystitis

Interventions

Fosfomycin; Emodin

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Quinones; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: This is a randomized, controlled, double-blinded, two-armed multicentre trial.

Study Record Dates

• First Submitted: September 11, 2021
• First Posted: September 24, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 24, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

HU (1)