NCT03379389

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
284

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2018

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

March 31, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

December 14, 2021

Status Verified

November 1, 2021

Enrollment Period

1.1 years

First QC Date

December 8, 2017

Last Update Submit

November 29, 2021

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

  • Urination regularity

    Percentage of subjects presenting improvement in cystitis symptoms in the "Urination Regularity" domain of the UTISA at Visit 2.

    Following three days of treatment with urinary antiseptics

Secondary Outcomes (9)

  • Total UTISA score

    From pretreatment to final visit, total of 6 days of treatment

  • UTISA question # 9

    At Visit 2, after 3 days of treatment

  • Adverse events

    From pretreatment to final visit, total of 6 days of treatment

  • Problems with Urination at Visit 2

    After 3 days of treatment

  • Problems with Urination at Visit 3

    After 6 days of treatment

  • +4 more secondary outcomes

Study Arms (2)

Methenamine + Methylthioninium

EXPERIMENTAL

Dosage: Methenamine (120mg) + Methylthioninium (20mg) Dosage form: coated tablets Frequency: 2 coated tablets twice daily Duration: 6 days

Drug: Methenamine + MethylthioniniumDrug: Antibiotics

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

Drug: Methenamine + Methylthioninium + Acriflavine + Atropa belladonaDrug: Antibiotics

Interventions

Methenamine + MethylthioniniumDRUG

Methenamine + Methylthioninium

Also known as: methenamine + methylene blue
Methenamine + Methylthioninium
Methenamine + Methylthioninium + Acriflavine + Atropa belladonaDRUG

Methenamine + Methylthioninium + Acriflavine + Atropa belladona

Also known as: methenamine + methylene blue + acriflavine + A. belladona
Methenamine+Methylthioninium+Acriflavine+Atropa belladona
AntibioticsDRUG

Antibiotics based on individual subjects urine culture / antibiogram

Also known as: Antimicrobials
Methenamine + MethylthioniniumMethenamine+Methylthioninium+Acriflavine+Atropa belladona

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Universitário Serra dos Órgãos - UNIFESO

Teresópolis, Rio de Janeiro, 25964004, Brazil

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

MethenamineMethylene BlueAcriflavineAnti-Bacterial AgentsAnti-Infective Agents

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PolyaminesAminesOrganic ChemicalsAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsPhenothiazinesSulfur CompoundsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAminoacridinesAcridinesTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • carlos p nunes, MD

    Fundação Educacional Serra dos Órgãos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Internal Medicine

Study Record Dates

First Submitted

December 8, 2017

First Posted

December 20, 2017

Study Start

March 31, 2018

Primary Completion

May 1, 2019

Study Completion

June 1, 2021

Last Updated

December 14, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)