Efficacy and Safety of Uronext® in Women With Cystitis (NCT05945667) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Safety of Uronext® in Women With Cystitis
Russia111 participantsStarted 2021-06-07
Plain-language summary
The study is designed as a prospective parallel open label, two-arm, single center study exploring efficacy and safety of the use of the dietary supplement Uronext in women with cystitis in the acute stage. 120 otherwise healthy women with acute cystitis infection confirmed with the urine bacteriological examinations, aged 18-18 years, will be recruited. The distribution of patients will be done in 1:1 ratio. Control group will receive standard therapy, Monural (fosfomycin trometamol) 3 g, at the first day of the trial. The second group will also receive Monural (fosfomycin trometamol) 3 g, at the first day of the trial as well as Uronext food supplement, 1 time per day for the first 7 days. After the 7 day break, participants in the second group will follow supplementation scheme for the next 3 month.
Primary objective of the study is evaluation of the effectiveness of the dietary supplement Uronext in women with cystitis in the acute stage in the prevention of subsequent exacerbations of recurrent cystitis during 3 months of observation, measured as the number of relapses throughout the study period. Participnats will also fill in urination diary and questionnaires related to pain perception, quality of life and cystitis symptoms. Urine samples will be further examined at the follow up visits.
Safety will be evaluated based on reported adverse events, assessment of vital signs and laboratory evaluation.
Who can participate
Age range
18 Years – 80 Years
Sex
FEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, epispa…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.