The Efficacy and Safety of Intravesical Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients

Study Overview
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Brief Summary
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The efficacy and safety of intravesical hyaluronic acid and chondroitin sulfate after transurethral resection of Hunner lesion in interstitial cystitis/bladder pain syndrome patients. To analyze the number and timing of recurrence based on a long-term follow-up.

Official Title
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The Efficacy and Safety of Intravesical Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients

Conditions
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Interstitial Cystitis

Intervention / Treatment
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* Drug: Hyaluronic Acid and Chondroitin Sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female aged 20 yrs or greater Patients diagnosed with Hunner lesion in IC(interstitial cystitis)/BPS(Bladder Pain Syndrome) and who is scheduled to undergo transurethral resection Symptom persisted more than 6 months Pain VAS ≥4 Exclusion Criteria: History of augmentation cystoplasty or previous transurethral coagulation/resection due to IC/BPS Child-bearing potential, pregnant or nursing women. Hematuria exceeds 1+ in the urinary dipstick (dipstick) examination. Urinary tract infection during run-in periods. Genitourinary tuberculosis or bladder,urethral and prostate cancer Recurrent urinary tract infection History of hysterectomy,mid-urethral sling,pelvic organ prolapse repair,vaginal delivery or Cesarean section,prostate operation or treatment etc within 6months. Neurologic disease history of cerebral infarction,multiple sclerosis or parkinsonism etc.- Using a indwelling catheter or execution of intermittent self catheterization

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyaluronic Acid and Chondroitin Sulfate<br>Intravesical instillation of Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients. | Drug: Hyaluronic Acid and Chondroitin Sulfate<br>* Intravesical instillation of Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in recurrence rate in Hyaluronic Acid and Chondroitin Sulfate instillation group after transurethral resection treatment |  | Every 3 months for 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in mean number of daytime frequency episodes |  | Every 3 months for 2 years | 
| changes in mean number of nocturia episodes |  | Every 3 months for 2 years | 
| changes in mean number of urgency episodes |  | Every 3 months for 2 years | 
| Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) |  | Every 3 months for 2 years | 
| Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF) |  | Every 3 months for 2 years | 
| Score of Global Response Assessment (GRA) |  | Every 3 months for 2 years | 
| Patient Global Assessment |  | at the end of the treatment(2 years) | 
| Occurrence of adverse event |  | Every 3 months for 2 years |