Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis

November 29, 2021 updated by: Carlos Pereira Nunes, Fundação Educacional Serra dos Órgãos
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
284

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RJ
      • Teresópolis, RJ, Brazil, 25964004
        • Centro Universitário Serra dos Órgãos - UNIFESO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Methenamine + Methylthioninium
Dosage: Methenamine (120mg) + Methylthioninium (20mg) Dosage form: coated tablets Frequency: 2 coated tablets twice daily Duration: 6 days
Drug: Methenamine + Methylthioninium
Methenamine + Methylthioninium
Other Names:
  • methenamine + methylene blue
Drug: Antibiotics
Antibiotics based on individual subjects urine culture / antibiogram
Other Names:
  • Antimicrobials
Active Comparator: Methenamine+Methylthioninium+Acriflavine+Atropa belladona
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
Drug: Antibiotics
Antibiotics based on individual subjects urine culture / antibiogram
Other Names:
  • Antimicrobials
Drug: Methenamine + Methylthioninium + Acriflavine + Atropa belladona
Methenamine + Methylthioninium + Acriflavine + Atropa belladona
Other Names:
  • methenamine + methylene blue + acriflavine + A. belladona

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Following three days of treatment with urinary antiseptics

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total UTISA score
Time Frame: From pretreatment to final visit, total of 6 days of treatment
Evolution of total UTISA score at end of study compared to pretreatment in each treatment group
From pretreatment to final visit, total of 6 days of treatment
UTISA question # 9
Time Frame: At Visit 2, after 3 days of treatment
Percentage of subjects with improvement in UTISA question 9 at Visit 2 in each treatment group
At Visit 2, after 3 days of treatment
Adverse events
Time Frame: From pretreatment to final visit, total of 6 days of treatment
Incidence of study drug-related adverse events in each treatment group
From pretreatment to final visit, total of 6 days of treatment
Problems with Urination at Visit 2
Time Frame: After 3 days of treatment
Evolution of UTISA domain "Problems with Urination" in each treatment Group
After 3 days of treatment
Problems with Urination at Visit 3
Time Frame: After 6 days of treatment
Evolution of UTISA domain "Problems with Urination" in each treatment Group
After 6 days of treatment
Pain Associated with UTI at Visit 2
Time Frame: After 3 days of treatment
Evolution of UTISA domain "Pain Associated with UTI" in each treatment Group
After 3 days of treatment
Pain Associated with UTI at Visit 3
Time Frame: After 6 days of treatment
Evolution of UTISA domain "Pain Associated with UTI" in each treatment Group
After 6 days of treatment
Blood in Urine at Visit 2
Time Frame: After 3 days of treatment
Evolution of UTISA domain "Blood in Urine" in each treatment Group
After 3 days of treatment
Blood in Urine at Visit 3
Time Frame: After 6 days of treatment
Evolution of UTISA domain "Blood in Urine" in each treatment Group
After 6 days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundação Educacional Serra dos Órgãos

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: carlos p nunes, MD, Fundação Educacional Serra dos Órgãos

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AUCR-01-05-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Urinary Tract Infections

Clinical Trials on Methenamine + Methylthioninium

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings