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No benefit of intravesical instillation of Hyaluronic Acid/Chondroitin Sulfate
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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.
This is a randomized, parallel, 6 month period study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Additional instillation of hyaluronic acid/chondroitin sulfate | Experimental | Transurethral resection of bladder ulcer + instillation of hyaluronic acid/chondroitin sulfate |
|
| Transurethral resection of bladder ulcer | Active Comparator | Transurethral resection of bladder ulcer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic acid/chondroitin sulfate | Drug | Additional Hyaluronic acid/chondroitin sulfate instillation to the bladder |
|
| 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 |
| 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 |
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Inclusion Criteria:
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
Patients had prior surgery (eq, bladder augmentation, cystectomy
Patients with neurologic disorder
Patients with indwelling catheter or intermittent self-catheterization
Patients with psychologic problem
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| Name | Affiliation | Role |
|---|---|---|
| Myung -Soo Choo, profesor | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan medical center | Seoul | South Korea |
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|
| 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 |
| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D018960 | Hyaluronan Receptors |
| C501944 | chondroitin sulfate, sodium hyaluronate drug combination |
| ID | Term |
|---|---|
| D016201 | Receptors, Lymphocyte Homing |
| D015815 | Cell Adhesion Molecules |
| D008562 | Membrane Glycoproteins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D011508 | Chondroitin Sulfate Proteoglycans |
| D011509 | Proteoglycans |
| D011134 | Polysaccharides |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008565 | Membrane Proteins |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D000954 | Antigens, Surface |
| D000941 | Antigens |
| D001685 | Biological Factors |
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