Back to resultsEfficacy of IARULIL® in the Treatment of Recurrent Cystitis Refractory to Escherichia Coli Extract
Primary Purpose
Recurrent Cystitis
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
hyaluronic acid and chondroitin sulphate
Sponsored by
About this trial
This is an interventional prevention trial for Recurrent Cystitis focused on measuring Recurrent cystitis, hyaluronic acid, chondroitin sulphate
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treatment group
Arm Description
-Intervention: combined intravesical therapy with hyaluronic acid and chondroitin sulphate(IALURIL®) ( 1st month: once a week, 2nd~5th month:once a month)
Outcomes
Primary Outcome Measures
The number of recurrence for recurrent cystitis
Secondary Outcome Measures
Time interval of cystitis
The score change of UTI symptom Assessment questionnaire(UTISA)
Global Respone assessment(GRA) score assessment
safety evaluation Safety evaluation
Full Information
NCT ID
NCT02366676
First Posted
February 12, 2015
Last Updated
November 28, 2019
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02366676
Brief Title
Efficacy of IARULIL® in the Treatment of Recurrent Cystitis Refractory to Escherichia Coli Extract
Official Title
Efficacy of Combined Intravesical Therapy With Hyaluronic Acid and Chondroitin Sulphate in the Treatment of Recurrent Cystitis Refractory to Escherichia Coli Extract: a Multicenter, Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
October 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
The purpose of this study is to evaluate the efficacy of combined intravesical therapy with hyaluronic acid and chondroitin sulphate(IARULIL®) in the treatment of recurrent cystitis refractory to oral Escherichia Coli extract(Uro-Vaxom®) and the change of urinary tract infection symptoms after intravesical instillation treatment with IARULIL®.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Cystitis
Keywords
Recurrent cystitis, hyaluronic acid, chondroitin sulphate
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Arm Description
-Intervention: combined intravesical therapy with hyaluronic acid and chondroitin sulphate(IALURIL®) ( 1st month: once a week, 2nd~5th month:once a month)
Intervention Type
Drug
Intervention Name(s)
hyaluronic acid and chondroitin sulphate
Other Intervention Name(s)
IALURIL®
Intervention Description
IALURIL Intravesical instillation with cystoscope ( 1st month: once a week, 2nd~5th month:once a month)
Primary Outcome Measure Information:
Title
The number of recurrence for recurrent cystitis
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Time interval of cystitis
Time Frame
12months
Title
The score change of UTI symptom Assessment questionnaire(UTISA)
Time Frame
12months
Title
Global Respone assessment(GRA) score assessment
Time Frame
12 month after treatment
Title
safety evaluation Safety evaluation
Time Frame
12 month after treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu-Sung Lee, M.D., Ph.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul,
ZIP/Postal Code
130-710
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy of IARULIL® in the Treatment of Recurrent Cystitis Refractory to Escherichia Coli Extract
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