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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02366676

Enrollment

105

Registered

2015-02-19

Start date

2014-01-31

Completion date

2019-10-30

Last updated

2019-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Cystitis

Keywords

Recurrent cystitis, hyaluronic acid, chondroitin sulphate

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®.

Interventions

DRUGhyaluronic acid and chondroitin sulphate

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
The number of recurrence for recurrent cystitis	12 months

Secondary

Measure	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026