The Efficacy of Additional Intravesical Instillation of Hyaluronic Acid/Chondroitin Sulfate to Transurethral Resection of Bladder Ulcer in Patients With Interstitial Cystitis/Bladder Pain Syndrome.

Study Overview
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Brief Summary
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The purpose of this study is to evaluate efficacy and safety of additional hyaluronic acid/chondroitin sulfate to transurethral resection of bladder ulcer in patient with interstitial cystitis.

Detailed Description
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This is a randomized, parallel, 6 month period study.

Official Title
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The Efficacy of Additional Intravesical Instillation of Hyaluronic Acid/Chondroitin Sulfate to Transurethral Resection of Bladder Ulcer in Patients With Interstitial Cystitis/Bladder Pain Syndrome.

Conditions
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Interstitial Cystitis

Intervention / Treatment
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* Drug: Hyaluronic acid/chondroitin sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: must have experienced bladder pain, urinary urgency and urinary frequency, for at least 6 months prior to entry into the study Pain VAS ≥4 O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) symptom and problem ≥ 12( and pain ≥2, and nocturia ≥ 2) PUF score ≥ 13 cystoscopic record within 2 years Hunner ulcer lesion in cystoscopic finding Exclusion Criteria: Scheduled for or use of intravesical therapy (eg, bladder distention,transurethral resection of bladder ulcer, instillation) during or within 6months prior to the study and use of pentosan polysulfate sodium within 1 months prior to the study Patients who are pregnancy or, childbearing age without no contraception Patients with voided volume <40 or, > 400ml Patients with microscopic hematuria, (≥1+ in dipstick), If not excluded that no evidence of neoplastic tumor examination Patients with urine culture showing evidence of urinary tract infection 1month prior to the study Accompanied medical problem below Tuberculosis in urinary system Bladder cancer, urethral cancer, prostate cancer Recurrent cystitis anatomical disorder Patients had prior surgery (eq, bladder augmentation, cystectomy Patients with neurologic disorder Patients with indwelling catheter or intermittent self-catheterization Patients with psychologic problem

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Additional instillation of hyaluronic acid/chondroitin sulfate<br>Transurethral resection of bladder ulcer + instillation of hyaluronic acid/chondroitin sulfate | Drug: Hyaluronic acid/chondroitin sulfate<br>* Additional Hyaluronic acid/chondroitin sulfate instillation to the bladder<br>* Other names: Ialuril;|
| Active Comparator: Transurethral resection of bladder ulcer<br>Transurethral resection of bladder ulcer | Drug: Hyaluronic acid/chondroitin sulfate<br>* Additional Hyaluronic acid/chondroitin sulfate instillation to the bladder<br>* Other names: Ialuril;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of pain scores on the Visual Analogue Scale | Change of pain scores on the Visual Analogue Scale | 1month, 3month, 6month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of symptom improvement | Duration of symptom improvement | 1month, 3month, 6month | 
| Changes of frequency and urgency on voiding diary | Changes of frequency and urgency on voiding diary | 1month, 3month, 6month | 
| Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) | Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) | 1month, 6month | 
| Score of Global Response Assessment (GRA), Patient Global Assessment (PGA) score | Score of Global Response Assessment (GRA), Patient Global Assessment | 6month | 
| Occurrence of adverse event | Occurrence of adverse event | 6month | 
| Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF) | Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale | 1month, 6month | 
| Change score of EQ-5D Health Questionnaire | Change score of EQ-5D Health Questionnaire | 1month, 6month | 
| Change score of Brief Pain Inventory-short form (BPI-sf) | Change score of Brief Pain Inventory-short form (BPI-sf) | 1month, 6month |