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Completed

NCT Number: NCT02366676

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

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

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Key information

Conditions

Recurrent Cystitis Cystitis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

20 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Samsung Medical Center

Seoul, 130-710, South Korea

About this study

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®.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • female patients aged between 20 and 80 years
  • Patients diagnosed with recurrent cystitis and treated with Escherichia Coli Extract
  • Patients with Refractory to Escherichia Coli Extract treatment

Exclusion criteria

  • child-bearing potential, pregnant or nursing women.
  • Residual urine volume >100ml
  • genitourinary tuberculosis or cancer / anatomical abnomality of genitourinary tract / neurologic abnormality of low urinary tract.
  • history of treatment for acute cystitis within 2weeks.

Treatment and study plan

hyaluronic acid and chondroitin sulphate

Drug

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

Other names: IALURIL®

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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Feb 19, 2015
Registry last updated
Dec 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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