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

Samsung Medical Center

Status and phase: Completed; Phase 4

Conditions: Recurrent Cystitis

Treatments: Drug: hyaluronic acid and chondroitin sulphate

Study type: Interventional

Funder types: Other

Identifiers

NCT02366676

2013-07-170

Details and patient eligibility

About

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

Full 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®.

Enrollment: 105 estimated patients

Sex: Female

Ages: 20 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

105 participants in 1 patient group

treatment group

Experimental group

Description:

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

Treatment:

Drug: hyaluronic acid and chondroitin sulphate