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

Recurrent Cystitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02366676
• Other study ID #: 2013-07-170
• Status: Completed
• Phase: Phase 4
• Start date: January 2014
• Est. completion date: October 30, 2019

Study information

• Verified date: November 2019
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: October 30, 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cystitis
• Recurrent Cystitis

Intervention

Drug:
• hyaluronic acid and chondroitin sulphate
IALURIL Intravesical instillation with cystoscope ( 1st month: once a week, 2nd~5th month:once a month)

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul,

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of recurrence for recurrent cystitis		12 months
Secondary	Time interval of cystitis		12months
Secondary	The score change of UTI symptom Assessment questionnaire(UTISA)		12months
Secondary	Global Respone assessment(GRA) score assessment		12 month after treatment
Secondary	safety evaluation Safety evaluation		12 month after treatment