Clinical trial NCT03379389: Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis
Official title: Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Tract Infections
Lead sponsor: Fundação Educacional Serra dos Órgãos
Sponsor class: OTHER
First posted: 2017-12-20
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Urination regularity
timeFrame: Following three days of treatment with urinary antiseptics
Secondary outcomes:
measure: Total UTISA score
timeFrame: From pretreatment to final visit, total of 6 days of treatment
measure: UTISA question # 9
timeFrame: At Visit 2, after 3 days of treatment
measure: Adverse events
timeFrame: From pretreatment to final visit, total of 6 days of treatment
measure: Problems with Urination at Visit 2
timeFrame: After 3 days of treatment
measure: Problems with Urination at Visit 3
timeFrame: After 6 days of treatment
measure: Pain Associated with UTI at Visit 2
timeFrame: After 3 days of treatment
measure: Pain Associated with UTI at Visit 3
timeFrame: After 6 days of treatment
measure: Blood in Urine at Visit 2
timeFrame: After 3 days of treatment
measure: Blood in Urine at Visit 3
timeFrame: After 6 days of treatment
Other outcomes:
Locations:
city: Teresópolis
country: Brazil
facility: Centro Universitário Serra dos Órgãos - UNIFESO
state: RJ
Study officials:
affiliation: Fundação Educacional Serra dos Órgãos
name: carlos p nunes, MD
role: PRINCIPAL_INVESTIGATOR
References: