CystitisNCT05945667
Efficacy and Safety of Uronext® in Women With Cystitis
A study testing Monural and UroNext in people with Cystitis, run by PharmaLinea Ltd. at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Cystitis
- What is being tested?
- Monural and UroNext
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteRussia
- Study dates
- 7 Jun 2021to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Urology Clinic of Moscow State University of Medicine and Dentistry
Moscow
About this study
Official title: Prospective Study on the Efficacy and Safety of Uronext® in Parallel Groups in Women With Cystitis in the Acute Stage
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
- Being tested
- Monural, UroNext
- Medical subject headings
- Cystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MonuralDrug
1 sachet, only 1st day of trial
UroNextDietary supplement
1 sachet per day for the first 7 days, followed by 7 days break Same scheme to be repeated for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Monural | Active comparator | 3000 mg of fosfomycin trometamol per sachet Receives: Drug: Monural |
| 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 Receives: Drug: Monural; Dietary Supplement: UroNext |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cystitis relapses
Proportion of patients who did not have relapses of the disease at Visit 3
Measured: 3 months
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 6, 24, 48, and 72 hours
Recurrence rate
Recurrence rate between Visit 1 and Visit 3
Measured: 3 months
Urination frequency
Urination frequency based on the Urination Diary on Days 1, 2, and 3 of observation.
Measured: 3 days
Average urine volume
Average urine volume based on the Urination Diary on Days 1, 2, and 3 of observation.
Measured: 3 days
Microorganism growth in urine culture
Proportion of patients with no microorganism growth in urine culture at Visit 2 and 3
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start7 Jun 2021
- Primary completion21 Dec 2021
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaLinea Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NPO Petrovax Pharm LLC.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945667
- Sponsor's protocol ID
- UN-1
- Status last verified
- Jul 2023
- First submitted
- 6 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on the Efficacy and Safety of Uronext® in Parallel Groups in Women With Cystitis in the Acute Stage
- ClinicalTrials.gov ID
- NCT05945667
- Acronym / sponsor ID
- UN-1
- Conditions
- Cystitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- PharmaLinea Ltd.Industry (pharma, biotech, devices)
- Collaborators
- NPO Petrovax Pharm LLC.
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monural | Active comparator | Drug: Monural3000 mg of fosfomycin trometamol per sachet |
| UroNext + Monural | Experimental | Drug: Monural, Dietary Supplement: UroNext3000 mg of fosfomycin trometamol per sachet 500 mg of Qcran, 2000 mg of D-mannose, 5 mcg of vitamin D3 per sachet |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monural1 sachet, only 1st day of trial | Drug | Monural, UroNext + Monural |
| UroNext1 sachet per day for the first 7 days, followed by 7 days break Same scheme to be repeated for 3 months | Dietary supplement | UroNext + Monural |
Primary outcome
Cystitis relapses
Time frame: 3 months
Proportion of patients who did not have relapses of the disease at Visit 3
12 secondary outcomes
Pain intensity on the 100 mm Visual Analog Scale
Time frame: 3 days
Urinary urge severity on the 100 mm Visual Analog Scale
Time frame: 6, 24, 48, and 72 hours
Urinary frequency severity on the 100 mm Visual Analog Scale
Time frame: 6, 24, 48, and 72 hours
Recurrence rate
Time frame: 3 months
Urination frequency
Time frame: 3 days
Average urine volume
Time frame: 3 days
Microorganism growth in urine culture
Time frame: 3 months
Acute Cystitis Symptom Score Questionnaire - Typical
Time frame: 3 months
Acute Cystitis Symptom Score Questionnaire (ACSS) - Differential
Time frame: 3 months
Acute Cystitis Symptom Score Questionnaire (ACSS) - QoL
Time frame: 3 months
Acute Cystitis Symptom Score Questionnaire (ACSS) - Dynamics
Time frame: 3 months
Quality of Life Visual Analog Scale
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monural and UroNext in people with Cystitis, run by PharmaLinea Ltd. at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cystitis relapses (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.