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

NCT ID: NCT02366676

Last Updated: 2019-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2019-10-30

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®.

Conditions

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Recurrent Cystitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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treatment group

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

Group Type EXPERIMENTAL

hyaluronic acid and chondroitin sulphate

Intervention Type DRUG

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

Interventions

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hyaluronic acid and chondroitin sulphate

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

Intervention Type DRUG

Other Intervention Names

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IALURIL®

Eligibility Criteria

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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

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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KYU-SUNG LEE

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kyu-Sung Lee, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2013-07-170

Identifier Type: -

Identifier Source: org_study_id

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