Urinary Tract InfectionsPhase 4NCT03379389
Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis
A Phase 4 study testing Methenamine + Methylthioninium, Methenamine + Methylthioninium + Acriflavine + Atropa belladona and Antibiotics in people with Urinary Tract Infections, run by Fundação Educacional Serra dos Órgãos at 1 site in Brazil.
Trial summary
This is a double-blind, randomized, double-dummy, comparative study in parallel groups of subjects presenting with recurrent cystitis (≥2 episodes within the past 6 months). Subjects will be randomized and treated with one of two presentations of urinary antiseptics containing methenamine and methylthioninium for… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Methenamine + Methylthioninium, Methenamine + Methylthioninium + Acriflavine + Atropa belladona and Antibiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteBrazil
- Study dates
- 31 Mar 2018to 1 Jun 2021
- Phase
- Phase 4
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes, age ≥18
- Clinical diagnosis of recurrent cystitis (≥ 2 episodes in the past 6 months)
- Female subject of reproductive age not pregnant, agrees to use birth control during study period
- Subject has read, understood, signed and dated informed consent document
Who cannot join
- History of nephritis or kidney stones
- History of hepatic or gastrointestinal disease
- Diabetes
- Glaucoma
- Female subjects: pregnancy or breastfeeding
- History of anatomical alterations contributing to recurring cystitis on imaging exams
- Hypersensitivity to any component of study drug
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro Universitário Serra dos Órgãos - UNIFESO
Teresópolis, Rio de Janeiro, 25964004
About this study
This is a double-blind, randomized, double-dummy, comparative study in parallel groups of subjects presenting with recurrent cystitis (≥2 episodes within the past 6 months). Subjects will be randomized and treated with one of two presentations of urinary antiseptics containing methenamine and methylthioninium for three days, followed by three days of antibiotic therapy as determined by urine culture and antibiogram. This study aims to assess the efficacy and safety of each treatment.
Read the detailed description
This is a double-blind, randomized, double-dummy, comparative study in parallel groups of subjects presenting with recurrent cystitis (≥2 episodes within the past 6 months). After initial evaluations including urine culture and antibiogram, a total of 284 subjects will be randomized and treated with one of two presentations of urinary antiseptics containing methenamine and methylthioninium for six days. After three days of treatment, subjects will return to the study center and antibiotic therapy based on the results of the urine culture and antibiogram will be initiated for each subject, to be continued for the remaining three days of the treatment period. Efficacy assessments will include the UTISA (Urinary Tract Infection Symptoms Assessment Questionnaire) together with a global assessment by the investigator. Safety assessments will include monitoring of adverse events and laboratory tests carried out at each of the three study visits.
- Conditions
- Urinary Tract Infections
- Being tested
- Methenamine + Methylthioninium, Methenamine + Methylthioninium + Acriflavine + Atropa belladona, Antibiotics
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methenamine + MethylthioniniumDrug
Also called methenamine + methylene blue
Methenamine + Methylthioninium
Methenamine + Methylthioninium + Acriflavine + Atropa belladonaDrug
Also called methenamine + methylene blue + acriflavine + A. belladona
Methenamine + Methylthioninium + Acriflavine + Atropa belladona
AntibioticsDrug
Also called Antimicrobials
Antibiotics based on individual subjects urine culture / antibiogram
| Study group | Role | What they receive |
|---|---|---|
| Methenamine + Methylthioninium | Experimental | Dosage: Methenamine (120mg) + Methylthioninium (20mg) Dosage form: coated tablets Frequency: 2 coated tablets twice daily Duration: 6 days Receives: Drug: Methenamine + Methylthioninium; Drug: Antibiotics |
| Methenamine+Methylthioninium+Acriflavine+Atropa belladona | Active comparator | Dosage: Methenamine (250mg) + Methylthioninium (20mg) + Acriflavine hydrochloride (15mg) + Atropa belladonna L. (15mg) Dosage form: coated tablets Frequency: 2 coated tablets twice daily Duration: 6 days Receives: Drug: Methenamine + Methylthioninium + Acriflavine + Atropa belladona; Drug: Antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urination regularity
Percentage of subjects presenting improvement in cystitis symptoms in the "Urination Regularity" domain of the UTISA at Visit 2.
Measured: Following three days of treatment with urinary antiseptics
Secondary outcomes (9)
Total UTISA score
Evolution of total UTISA score at end of study compared to pretreatment in each treatment group
Measured: From pretreatment to final visit, total of 6 days of treatment
UTISA question # 9
Percentage of subjects with improvement in UTISA question 9 at Visit 2 in each treatment group
Measured: At Visit 2, after 3 days of treatment
Adverse events
Incidence of study drug-related adverse events in each treatment group
Measured: From pretreatment to final visit, total of 6 days of treatment
Problems with Urination at Visit 2
Evolution of UTISA domain "Problems with Urination" in each treatment Group
Measured: After 3 days of treatment
Problems with Urination at Visit 3
Evolution of UTISA domain "Problems with Urination" in each treatment Group
Measured: After 6 days of treatment
Pain Associated with UTI at Visit 2
Evolution of UTISA domain "Pain Associated with UTI" in each treatment Group
Measured: After 3 days of treatment
Pain Associated with UTI at Visit 3
Evolution of UTISA domain "Pain Associated with UTI" in each treatment Group
Measured: After 6 days of treatment
Blood in Urine at Visit 2
Evolution of UTISA domain "Blood in Urine" in each treatment Group
Measured: After 3 days of treatment
Blood in Urine at Visit 3
Evolution of UTISA domain "Blood in Urine" in each treatment Group
Measured: After 6 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start31 Mar 2018
- Primary completion1 May 2019
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundação Educacional Serra dos Órgãos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Pereira Nunes, Fundação Educacional Serra dos Órgãos
- Investigators
- carlos p nunes, MD, Principal investigator, Fundação Educacional Serra dos Órgãos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379389
- Sponsor's protocol ID
- AUCR-01-05-17
- Status last verified
- Nov 2021
- First submitted
- 8 Dec 2017
- Last updated
- 14 Dec 2021
- Results posted
- 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 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis
- ClinicalTrials.gov ID
- NCT03379389
- Acronym / sponsor ID
- AUCR-01-05-17
- Conditions
- Urinary Tract Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Fundação Educacional Serra dos ÓrgãosUniversity, hospital or other
- Study start
- 31 Mar 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 20 Dec 2017 (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.
This is a double-blind, randomized, double-dummy, comparative study in parallel groups of subjects presenting with recurrent cystitis (≥2 episodes within the past 6 months). Subjects will be randomized and treated with one of two presentations of urinary antiseptics containing methenamine and methylthioninium for three days, followed by three days of antibiotic therapy as determined by urine culture and antibiogram. This study aims to assess the efficacy and safety of each treatment.
Detailed description
This is a double-blind, randomized, double-dummy, comparative study in parallel groups of subjects presenting with recurrent cystitis (≥2 episodes within the past 6 months). After initial evaluations including urine culture and antibiogram, a total of 284 subjects will be randomized and treated with one of two presentations of urinary antiseptics containing methenamine and methylthioninium for six days. After three days of treatment, subjects will return to the study center and antibiotic therapy based on the results of the urine culture and antibiogram will be initiated for each subject, to be continued for the remaining three days of the treatment period. Efficacy assessments will include the UTISA (Urinary Tract Infection Symptoms Assessment Questionnaire) together with a global assessment by the investigator. Safety assessments will include monitoring of adverse events and laboratory tests carried out at each of the three study visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methenamine + Methylthioninium | Experimental | Drug: Methenamine + Methylthioninium, Drug: AntibioticsDosage: Methenamine (120mg) + Methylthioninium (20mg) Dosage form: coated tablets Frequency: 2 coated tablets twice daily Duration: 6 days |
| Methenamine+Methylthioninium+Acriflavine+Atropa belladona | Active comparator | Drug: Methenamine + Methylthioninium + Acriflavine + Atropa belladona, Drug: AntibioticsDosage: Methenamine (250mg) + Methylthioninium (20mg) + Acriflavine hydrochloride (15mg) + Atropa belladonna L. (15mg) Dosage form: coated tablets Frequency: 2 coated tablets twice daily Duration: 6 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of both sexes, age ≥18
- Clinical diagnosis of recurrent cystitis (≥ 2 episodes in the past 6 months)
- Female subject of reproductive age not pregnant, agrees to use birth control during study period
- Subject has read, understood, signed and dated informed consent document
Key exclusion criteria (7 listed)
- History of nephritis or kidney stones
- History of hepatic or gastrointestinal disease
- Diabetes
- Glaucoma
- Female subjects: pregnancy or breastfeeding
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 |
|---|---|---|
| Methenamine + MethylthioniniumAlso: methenamine + methylene blueMethenamine + Methylthioninium | Drug | Methenamine + Methylthioninium |
| Methenamine + Methylthioninium + Acriflavine + Atropa belladonaAlso: methenamine + methylene blue + acriflavine + A. belladonaMethenamine + Methylthioninium + Acriflavine + Atropa belladona | Drug | Methenamine+Methylthioninium+Acriflavine+Atropa belladona |
| AntibioticsAlso: AntimicrobialsAntibiotics based on individual subjects urine culture / antibiogram | Drug | Methenamine + Methylthioninium, Methenamine+Methylthioninium+Acriflavine+Atropa belladona |
Primary outcome
Urination regularity
Time frame: Following three days of treatment with urinary antiseptics
Percentage of subjects presenting improvement in cystitis symptoms in the "Urination Regularity" domain of the UTISA at Visit 2.
9 secondary outcomes
Total UTISA score
Time frame: From pretreatment to final visit, total of 6 days of treatment
UTISA question # 9
Time frame: At Visit 2, after 3 days of treatment
Adverse events
Time frame: From pretreatment to final visit, total of 6 days of treatment
Problems with Urination at Visit 2
Time frame: After 3 days of treatment
Problems with Urination at Visit 3
Time frame: After 6 days of treatment
Pain Associated with UTI at Visit 2
Time frame: After 3 days of treatment
Pain Associated with UTI at Visit 3
Time frame: After 6 days of treatment
Blood in Urine at Visit 2
Time frame: After 3 days of treatment
Blood in Urine at Visit 3
Time frame: After 6 days of treatment
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 14 Dec 2021.
- 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.
carlos p nunes, MD principal investigator
Fundação Educacional Serra dos Órgãos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methenamine + Methylthioninium, Methenamine + Methylthioninium + Acriflavine + Atropa belladona and Antibiotics in people with Urinary Tract Infections, run by Fundação Educacional Serra dos Órgãos at 1 site in Brazil.
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 4 inclusion and 7 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 14 Dec 2021. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Urination regularity (time frame: Following three days of treatment with urinary antiseptics). 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 14 Dec 2021.