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

Phase 4

Completed

• Conditions: Recurrent Cystitis
• Interventions: Drug: hyaluronic acid and chondroitin sulphate

• Registration Number: NCT02366676
• Lead Sponsor: Samsung Medical Center

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®.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2015-02-12
• Study First Submitted QC: 2015-02-18
• Study First Posted: 2015-02-19
• Primary Completion: 2018-01
• Study Completion: 2019-10-30
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-28
• Last Update Posted: 2019-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 105

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The number of recurrence for recurrent cystitis	12 months

Secondary Outcome Measures

Name	Time	Method
Time interval of cystitis	12months
safety evaluation Safety evaluation	12 month after treatment
The score change of UTI symptom Assessment questionnaire(UTISA)	12months
Global Respone assessment(GRA) score assessment	12 month after treatment

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul,, Korea, Republic of