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 range18 Years – 80 Years

SexALL

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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

What they're measuring

Urination regularity

Timeframe: Following three days of treatment with urinary antiseptics

Trial details

NCT IDNCT03379389

SponsorFundação Educacional Serra dos Órgãos

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-05-01

View on ClinicalTrials.gov More Urinary Tract Infections trials