Efficacy of IARULIL® in the Treatment of Recurrent Cystitis Refractory to Escherichia Coli Extract

Study Overview
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Brief Summary
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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
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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®.

Official Title
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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

Conditions
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Recurrent Cystitis

Intervention / Treatment
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* Drug: hyaluronic acid and chondroitin sulphate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>-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<br>* IALURIL Intravesical instillation with cystoscope ( 1st month: once a week, 2nd 5th month:once a month)<br>* Other names: IALURIL®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of recurrence for recurrent cystitis |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent cystitis, hyaluronic acid, chondroitin sulphate