Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis

What Was Tested

In this phase 4 trial, researchers set out to test Methylene blue (non-peptide stack partner).

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.

It had two arms (groups): Methenamine + Methylthioninium (experimental) and Methenamine+Methylthioninium+Acriflavine+Atropa belladona (active comparator).

The registry classes the interventions as drug.

More on the Plan

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.

Safety assessments will include monitoring of adverse events and laboratory tests carried out at each of the three study visits.

Who Took Part

The registry lists 284 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could 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.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: history of nephritis or kidney stones; history of hepatic or gastrointestinal disease; female subjects: pregnancy or breastfeeding.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Methylene blue (non-peptide stack partner) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Methylene blue (non-peptide stack partner), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2018-03-31 with completion listed for 2019-05-01.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Urination regularity (time frame: Following three days of treatment with urinary antiseptics).

It also tracked 9 secondary outcomes, for example Total UTISA score, UTISA question # 9, Adverse events, Problems with Urination at Visit 2, Problems with Urination at Visit 3 and Blood in Urine at Visit 2.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Methylene blue (non-peptide stack partner) in 284 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.