An interventional study of Monural and UroNext in Cystitis, sponsored by PharmaLinea Ltd.. Completed at 1 site in Russian Federation. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by PharmaLinea Ltd. · Not applicable, Interventional, and Other
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.
235 studies on the registry are indexed under Cystitis; 22 are open to participants now.
This study's enrollment of 111 is above the median of 60 across 170 interventional studies indexed under Cystitis.
Browse Cystitis studies →PharmaLinea Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
3000 mg of fosfomycin trometamol per sachet
Drug: Monural
3000 mg of fosfomycin trometamol per sachet 500 mg of Qcran, 2000 mg of D-mannose, 5 mcg of vitamin D3 per sachet
Drug: Monural · Dietary Supplement: UroNext
1 sachet, only 1st day of trial
1 sachet per day for the first 7 days, followed by 7 days break Same scheme to be repeated for 3 months
Cystitis relapses
Proportion of patients who did not have relapses of the disease at Visit 3
Time frame: 3 months
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.
Time frame: 3 days
Urinary urge severity on the 100 mm Visual Analog Scale
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.
Time frame: 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.
Time frame: 6, 24, 48, and 72 hours
Recurrence rate
Recurrence rate between Visit 1 and Visit 3
Time frame: 3 months
Urination frequency
Urination frequency based on the Urination Diary on Days 1, 2, and 3 of observation.
Time frame: 3 days
Average urine volume
Average urine volume based on the Urination Diary on Days 1, 2, and 3 of observation.
Time frame: 3 days
Microorganism growth in urine culture
Proportion of patients with no microorganism growth in urine culture at Visit 2 and 3
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3 months
Plan to share: No
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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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