NCT02366676

Brief Summary

The purpose of this study is to evaluate the efficacy of Combined Intravesical Therapy With Hyaluronic Acid and Chondroitin Sulphate in the Treatment of Recurrent Cystitis Refractory to Escherichia Coli Extract

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2014

Longer than P75 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

Study Start

First participant enrolled

January 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

December 2, 2019

Status Verified

November 1, 2019

Enrollment Period

4 years

First QC Date

February 12, 2015

Last Update Submit

November 28, 2019

Conditions

Recurrent Cystitis

Keywords

Recurrent cystitishyaluronic acidchondroitin sulphate

Outcome Measures

Primary Outcomes (1)

  • The number of recurrence for recurrent cystitis

    12 months

Secondary Outcomes (4)

  • Time interval of cystitis

    12months

  • The score change of UTI symptom Assessment questionnaire(UTISA)

    12months

  • Global Respone assessment(GRA) score assessment

    12 month after treatment

  • safety evaluation Safety evaluation

    12 month after treatment

Study Arms (1)

treatment group

EXPERIMENTAL

-Intervention: combined intravesical therapy with hyaluronic acid and chondroitin sulphate(IALURIL®) ( 1st month: once a week, 2nd\~5th month:once a month)

Drug: hyaluronic acid and chondroitin sulphate

Interventions

hyaluronic acid and chondroitin sulphateDRUG

IALURIL Intravesical instillation with cystoscope ( 1st month: once a week, 2nd\~5th month:once a month)

Also known as: IALURIL®
treatment group

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female patients aged between 20 and 80 years
  • Patients diagnosed with recurrent cystitis and treated with Escherichia Coli Extract
  • Patients with Refractory to Escherichia Coli Extract treatment

You may not qualify if:

  • child-bearing potential, pregnant or nursing women.
  • Residual urine volume \>100ml
  • genitourinary tuberculosis or cancer / anatomical abnomality of genitourinary tract / neurologic abnormality of low urinary tract.
  • history of treatment for acute cystitis within 2weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 130-710, South Korea

Location

MeSH Terms

Conditions

Cystitis

Interventions

Hyaluronic AcidChondroitinchondroitin sulfate, sodium hyaluronate drug combination

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Kyu-Sung Lee, M.D., Ph.D.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

February 12, 2015

First Posted

February 19, 2015

Study Start

January 1, 2014

Primary Completion

January 1, 2018

Study Completion

October 30, 2019

Last Updated

December 2, 2019

Record last verified: 2019-11

Locations

KR(1)