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CompletedNCT02366676Updated Dec 2, 2019

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

A Phase 4 interventional study of hyaluronic acid and chondroitin sulphate in Recurrent Cystitis, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to female participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-12-02.

Sponsored by Samsung Medical Center · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Jan 2014, registered Feb 2015).
Phase
Phase 4
Study type
Interventional
Enrollment
105
Allocation
Not applicable
Ages
20 Years to 80 Years
Sex
Female
01

Study 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

Read the 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®.

02

Conditions studied

  • Recurrent Cystitis

Keywords

  • Recurrent cystitis
  • hyaluronic acid
  • chondroitin sulphate
03

In context

Escherichia coli Infections

96 studies on the registry are indexed under Escherichia coli Infections; 17 are open to participants now.

This study's planned enrollment of 105 is above the median of 90 across 58 interventional studies indexed under Escherichia coli Infections.

Browse Escherichia coli Infections studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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

Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
105 participants (estimated)

Study arms

  • Experimental
    treatment group

    -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

  • Drughyaluronic acid and chondroitin sulphate

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

    Also known as: IALURIL®

06

What researchers measure

Primary outcomes

  1. The number of recurrence for recurrent cystitis

    Time frame: 12 months

Secondary outcomes

  1. Time interval of cystitis

    Time frame: 12months

  2. The score change of UTI symptom Assessment questionnaire(UTISA)

    Time frame: 12months

  3. Global Respone assessment(GRA) score assessment

    Time frame: 12 month after treatment

  4. safety evaluation Safety evaluation

    Time frame: 12 month after treatment

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Study locations

1 site
  • Samsung Medical Center
    Seoul,, 130-710, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02366676
Lead sponsor
Samsung Medical Center
Responsible party
KYU-SUNG LEE (professor, Samsung Medical Center) — Principal investigator
First posted
Feb 19, 2015
Start date
Jan 2014
Primary completion
Jan 2018
Completion
Oct 30, 2019
Last update
Dec 2, 2019

Study contacts

Kyu-Sung Lee, M.D., Ph.D.
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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