Interstitial Cystitis
Conditions
Brief summary
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
This is a randomized, parallel, 6 month period study.
Interventions
DRUGHyaluronic acid/chondroitin sulfate
Additional Hyaluronic acid/chondroitin sulfate instillation to the bladder
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. must have experienced bladder pain, urinary urgency and urinary frequency, for at least 6 months prior to entry into the study 2. Pain VAS ≥4 3. O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) symptom and problem ≥ 12( and pain ≥2, and nocturia ≥ 2) 4. PUF score ≥ 13 5. cystoscopic record within 2 years 6. Hunner ulcer lesion in cystoscopic finding
Exclusion criteria
1. 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 2. Patients who are pregnancy or, childbearing age without no contraception 3. Patients with voided volume \<40 or, \> 400ml 4. Patients with microscopic hematuria, (≥1+ in dipstick), If not excluded that no evidence of neoplastic tumor examination 5. Patients with urine culture showing evidence of urinary tract infection 1month prior to the study 6. Accompanied medical problem below * Tuberculosis in urinary system * Bladder cancer, urethral cancer, prostate cancer * Recurrent cystitis * anatomical disorder 7. Patients had prior surgery (eq, bladder augmentation, cystectomy 8. Patients with neurologic disorder 9. Patients with indwelling catheter or intermittent self-catheterization 10. Patients with psychologic problem
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of pain scores on the Visual Analogue Scale | 1month, 3month, 6month | Change of pain scores on the Visual Analogue Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of frequency and urgency on voiding diary | 1month, 3month, 6month | Changes of frequency and urgency on voiding diary |
| Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) | 1month, 6month | Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) |
| Score of Global Response Assessment (GRA), Patient Global Assessment (PGA) score | 6month | Score of Global Response Assessment (GRA), Patient Global Assessment |
| Duration of symptom improvement | 1month, 3month, 6month | Duration of symptom improvement |
| Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF) | 1month, 6month | Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale |
| Change score of EQ-5D Health Questionnaire | 1month, 6month | Change score of EQ-5D Health Questionnaire |
| Change score of Brief Pain Inventory-short form (BPI-sf) | 1month, 6month | Change score of Brief Pain Inventory-short form (BPI-sf) |
| Occurrence of adverse event | 6month | Occurrence of adverse event |
Countries
South Korea
Outcome results
None listed