---
title: Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis
nct_id: NCT03379389
overall_status: COMPLETED
phase: PHASE4
sponsor: Fundação Educacional Serra dos Órgãos
study_type: INTERVENTIONAL
primary_condition: Urinary Tract Infections
countries: Brazil
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03379389.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03379389"
ct_last_update_post_date: 2021-12-14
last_seen_at: "2026-05-12T06:03:04.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis

**NCT ID:** [NCT03379389](https://clinicaltrials.gov/study/NCT03379389)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 284
- **Lead Sponsor:** Fundação Educacional Serra dos Órgãos
- **Conditions:** Urinary Tract Infections
- **Start Date:** 2018-03-31
- **Completion Date:** 2021-06-01
- **CT.gov Last Update:** 2021-12-14

## 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

- **Minimum age:** 18 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Methenamine + Methylthioninium** (EXPERIMENTAL) — Dosage: Methenamine (120mg) + Methylthioninium (20mg) Dosage form: coated tablets Frequency: 2 coated tablets twice daily Duration: 6 days
- **Methenamine+Methylthioninium+Acriflavine+Atropa belladona** (ACTIVE_COMPARATOR) — 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

## Interventions

- **Methenamine + Methylthioninium** (DRUG) — Methenamine + Methylthioninium
- **Methenamine + Methylthioninium + Acriflavine + Atropa belladona** (DRUG) — Methenamine + Methylthioninium + Acriflavine + Atropa belladona
- **Antibiotics** (DRUG) — Antibiotics based on individual subjects urine culture / antibiogram

## Primary Outcomes

- **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.

## Secondary Outcomes

- **Total UTISA score** _(time frame: From pretreatment to final visit, total of 6 days of treatment)_
- **UTISA question # 9** _(time frame: At Visit 2, after 3 days of treatment)_
- **Adverse events** _(time frame: From pretreatment to final visit, total of 6 days of treatment)_
- **Problems with Urination at Visit 2** _(time frame: After 3 days of treatment)_
- **Problems with Urination at Visit 3** _(time frame: After 6 days of treatment)_
- **Pain Associated with UTI at Visit 2** _(time frame: After 3 days of treatment)_
- **Pain Associated with UTI at Visit 3** _(time frame: After 6 days of treatment)_
- **Blood in Urine at Visit 2** _(time frame: After 3 days of treatment)_
- **Blood in Urine at Visit 3** _(time frame: After 6 days of treatment)_

## Locations (1)

- Centro Universitário Serra dos Órgãos - UNIFESO, Teresópolis, Rio de Janeiro, Brazil

## Recent Field Changes (last 30 days)

- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.centro universitário serra dos órgãos - unifeso|teresópolis|rio de janeiro|brazil` — added _(2026-05-12)_

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*Canonical: https://parkinsonspathways.com/agent/trials/NCT03379389.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03379389*  
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