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Efficacy and Safety of Uronext® in Women With Cystitis

Primary Purpose

Cystitis

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Monural
UroNext
Sponsored by
PharmaLinea Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cystitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Arm Type

Active Comparator

Experimental

Arm Label

Monural

UroNext + Monural

Arm Description

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

Outcomes

Primary Outcome Measures

Cystitis relapses
Proportion of patients who did not have relapses of the disease at Visit 3

Secondary Outcome Measures

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.
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.
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.
Recurrence rate
Recurrence rate between Visit 1 and Visit 3
Urination frequency
Urination frequency based on the Urination Diary on Days 1, 2, and 3 of observation.
Average urine volume
Average urine volume based on the Urination Diary on Days 1, 2, and 3 of observation.
Microorganism growth in urine culture
Proportion of patients with no microorganism growth in urine culture at Visit 2 and 3
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
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
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
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
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

Full Information

First Posted
July 6, 2023
Last Updated
July 25, 2023
Sponsor
PharmaLinea Ltd.
Collaborators
NPO Petrovax Pharm LLC.
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1. Study Identification

Unique Protocol Identification Number
NCT05945667
Brief Title
Efficacy and Safety of Uronext® in Women With Cystitis
Official Title
Prospective Study on the Efficacy and Safety of Uronext® in Parallel Groups in Women With Cystitis in the Acute Stage
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 7, 2021 (Actual)
Primary Completion Date
December 21, 2021 (Actual)
Study Completion Date
February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PharmaLinea Ltd.
Collaborators
NPO Petrovax Pharm LLC.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystitis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monural
Arm Type
Active Comparator
Arm Description
3000 mg of fosfomycin trometamol per sachet
Arm Title
UroNext + Monural
Arm Type
Experimental
Arm Description
3000 mg of fosfomycin trometamol per sachet 500 mg of Qcran, 2000 mg of D-mannose, 5 mcg of vitamin D3 per sachet
Intervention Type
Drug
Intervention Name(s)
Monural
Intervention Description
1 sachet, only 1st day of trial
Intervention Type
Dietary Supplement
Intervention Name(s)
UroNext
Intervention Description
1 sachet per day for the first 7 days, followed by 7 days break Same scheme to be repeated for 3 months
Primary Outcome Measure Information:
Title
Cystitis relapses
Description
Proportion of patients who did not have relapses of the disease at Visit 3
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Pain intensity on the 100 mm Visual Analog Scale
Description
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
Title
Urinary urge severity on the 100 mm Visual Analog Scale
Description
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
Title
Urinary frequency severity on the 100 mm Visual Analog Scale
Description
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
Title
Recurrence rate
Description
Recurrence rate between Visit 1 and Visit 3
Time Frame
3 months
Title
Urination frequency
Description
Urination frequency based on the Urination Diary on Days 1, 2, and 3 of observation.
Time Frame
3 days
Title
Average urine volume
Description
Average urine volume based on the Urination Diary on Days 1, 2, and 3 of observation.
Time Frame
3 days
Title
Microorganism growth in urine culture
Description
Proportion of patients with no microorganism growth in urine culture at Visit 2 and 3
Time Frame
3 months
Title
Acute Cystitis Symptom Score Questionnaire - Typical
Description
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
Title
Acute Cystitis Symptom Score Questionnaire (ACSS) - Differential
Description
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
Title
Acute Cystitis Symptom Score Questionnaire (ACSS) - QoL
Description
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
Title
Acute Cystitis Symptom Score Questionnaire (ACSS) - Dynamics
Description
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
Title
Quality of Life Visual Analog Scale
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Urology Clinic of Moscow State University of Medicine and Dentistry
City
Moscow
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy and Safety of Uronext® in Women With Cystitis

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