Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis (NCT03379389) | Clinical Trial Compass
CompletedPhase 4
Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis
Brazil284 participantsStarted 2018-03-31
Plain-language 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 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested methenamine and methylthioninium — which is methylene blue — for recurrent cystitis, and it's already completed. Can you tell me whether the results are available, and what they showed about urination regularity as the main thing being measured?
2Since this was a Phase 4 trial, these medications had already been approved before the study started — does that mean there's more established safety data on them compared to earlier-phase treatments, and how does that affect whether they might be right for my situation?
3Recurrent UTIs can be really disruptive to daily life — how do methenamine and methylene blue work to prevent them, and how would taking these regularly fit into my routine compared to other options like low-dose antibiotics or D-mannose?
4Given that this trial is now completed, is there a standard treatment approach for recurrent cystitis that my care team would recommend I try first, or would the findings from this study actually change what you'd suggest for me?
5Are there any side effects or interactions with methenamine or methylene blue that I should know about before we discuss whether either of these could be part of my treatment plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Urination regularity
Timeframe: Following three days of treatment with urinary antiseptics