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| Name | Class |
|---|---|
| NPO Petrovax Pharm LLC. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monural | Active Comparator | 3000 mg of fosfomycin trometamol per sachet |
|
| UroNext + Monural | Experimental | 3000 mg of fosfomycin trometamol per sachet 500 mg of Qcran, 2000 mg of D-mannose, 5 mcg of vitamin D3 per sachet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monural | Drug | 1 sachet, only 1st day of trial |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cystitis relapses | Proportion of patients who did not have relapses of the disease at Visit 3 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity on the 100 mm Visual Analog Scale | The sum of the difference in pain intensity on the 100 mm Visual Analog Scale. 0 indicates that the pain isn't bothering, 100 indicates strongly bothering pain. | 3 days |
| Urinary urge severity on the 100 mm Visual Analog Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology Clinic of Moscow State University of Medicine and Dentistry | Moscow | Russia |
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| ID | Term |
|---|---|
| D003556 | Cystitis |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| UroNext |
| Dietary Supplement |
1 sachet per day for the first 7 days, followed by 7 days break Same scheme to be repeated for 3 months |
|
Urinary urge severity on a 100-mm visual analog scale after initiation of study therapy. 0 indicates that the urinary urge isn't bothering, 100 indicates strongly bothering urinary urge. |
| 6, 24, 48, and 72 hours |
| Urinary frequency severity on the 100 mm Visual Analog Scale | Urinary frequency severity on a 100-mm scale after initiation of study therapy. 0 indicates that the urinary frequency isn't bothering, 100 indicates strongly bothering urinary frequency. | 6, 24, 48, and 72 hours |
| Recurrence rate | Recurrence rate between Visit 1 and Visit 3 | 3 months |
| Urination frequency | Urination frequency based on the Urination Diary on Days 1, 2, and 3 of observation. | 3 days |
| Average urine volume | Average urine volume based on the Urination Diary on Days 1, 2, and 3 of observation. | 3 days |
| Microorganism growth in urine culture | Proportion of patients with no microorganism growth in urine culture at Visit 2 and 3 | 3 months |
| Acute Cystitis Symptom Score Questionnaire - Typical | Change in the Acute Cystitis Symptom Questionnaire score (ACSS) ) - Typical symptoms Likert scale with 6 items; for each item 0 indicates no issues and 3 sever issues | 3 months |
| Acute Cystitis Symptom Score Questionnaire (ACSS) - Differential | Change in the Acute Cystitis Symptom Questionnaire score (ACSS) - Differential symptom score Likert scale with 4 items; for each item 0 indicates no issues and 3 sever issues | 3 months |
| Acute Cystitis Symptom Score Questionnaire (ACSS) - QoL | Change in the Acute Cystitis Symptom Score Questionnaire (ACSS) - QoL Likert scale with 4 items; for each item 0 indicates not being affected and 3 being extremely affected | 3 months |
| Acute Cystitis Symptom Score Questionnaire (ACSS) - Dynamics | Change in the Acute Cystitis Symptom Score Questionnaire (ACSS) - Dynamics 1 question; 0 indicates feeling back to normal and 4 indicates feeling worse | 3 months |
| Quality of Life Visual Analog Scale | Change is Quality of Life Visual Analog Scale score 0 indicates symptomes are not bothering and 10 indicates extreme impact on quality of life | 3 months |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |