NCT05945667

Efficacy and Safety of Uronext® in Women With Cystitis

Prospective Study on the Efficacy and Safety of Uronext® in Parallel Groups in Women With Cystitis in the Acute Stage

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: PharmaLinea Ltd. · Industry
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cystitis

Interventions

Type	Name	Description
DRUG	Monural	1 sachet, only 1st day of trial
DIETARY_SUPPLEMENT	UroNext	1 sachet per day for the first 7 days, followed by 7 days break Same scheme to be repeated for 3 months

Timeline

• Start date: 2021-06-07
• Primary completion: 2021-12-21
• Completion: 2022-02-28
• First posted: 2023-07-14
• Last updated: 2023-07-27

Locations

1 site across 1 country: Russia