Efficacy and Safety of Uronext® in Women With Cystitis
Cystitis
About this trial
This is an interventional other trial for Cystitis
Eligibility Criteria
Inclusion Criteria: Women between the ages of 18 and 80. Patients who are able to fill out questionnaires, and wish to take part in the study. Cystitis in the acute stage. Informed consent to participate in the study. The patient's willingness and ability to fulfill the requirements of the protocol throughout the study. Consent of the patient and partner with preserved reproductive potential to use adequate methods of contraception (for example, a double barrier method) during the entire period of the study (including the period of follow-up). The presence of the gynecologist's conclusion obtained within 6 months before the patient's participation in the study about the absence of concomitant pathologies that can distort the results of the study. The presence of the results of bacteriological urine tests obtained within 7-10 days before the patient's participation in the study, pathogens of infections of the lower urinary tract. If the results of urine bacteriological examinations are not available, the results of urine culture tests performed at Visit 1 will be taken into account. Exclusion Criteria: Patients with signs of upper urinary tract infection, such as temperature above 38°C, side/lower back pain, or soreness. Burdened allergic history. Hypersensitivity to any of the components that make up the investigational drugs. Patients with congenital anomalies in the development of genitourinary organs (exstrophy of the bladder, hypospadias, epispadias). Patients after undergoing surgical interventions on the organs of the genitourinary system. Patients who at the time of inclusion in the study noted: neurogenic dysfunction of the bladder, urinary incontinence, sclerosis of the neck of the bladder, urethral stricture, stone / stones of the bladder, bladder cancer, diverticula of the bladder, as well as other diseases of the genitourinary organs requiring specialized treatment. Any malignant neoplasm in the anamnesis. Unsatisfactory glycemic control (HbA1c ≥8%) in diabetes mellitus. Patients with uncontrolled infection as a result of exposure to human immunodeficiency virus (HIV) and/or active hepatitis. Patients with a history of drug or alcohol dependence within the last 5 years. Any clinically significant condition due to which, according to the researcher, the patient cannot take part in the study; Pregnancy, lactation, pregnancy planning during the study. Patients with any other serious or uncontrollable physical or mental condition/disease that the Researcher determines may put the patient at high risk of being removed from the study may disrupt or disprove the results of the study or likely prevent the patient from complying with the requirements of the study or completing the study. Participation in another clinical trial less than 6 months before the start of the study. Any other conditions that the researcher believes may indicate that the patient is not eligible to participate in the study.
Sites / Locations
- Urology Clinic of Moscow State University of Medicine and Dentistry
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Monural
UroNext + Monural
3000 mg of fosfomycin trometamol per sachet
3000 mg of fosfomycin trometamol per sachet 500 mg of Qcran, 2000 mg of D-mannose, 5 mcg of vitamin D3 per sachet