Interstitial Cystitis
Conditions
Brief summary
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.
Interventions
DRUGHyaluronic Acid and Chondroitin Sulfate
Intravesical instillation of Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients.
Sponsors
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female aged 20 yrs or greater 2. Patients diagnosed with Hunner lesion in IC(interstitial cystitis)/BPS(Bladder Pain Syndrome) and who is scheduled to undergo transurethral resection 3. Symptom persisted more than 6 months 4. Pain VAS ≥4
Exclusion criteria
1. History of augmentation cystoplasty or previous transurethral coagulation/resection due to IC/BPS 2. Child-bearing potential, pregnant or nursing women. 3. Hematuria exceeds 1+ in the urinary dipstick (dipstick) examination. 4. Urinary tract infection during run-in periods. 5. Genitourinary tuberculosis or bladder,urethral and prostate cancer 6. Recurrent urinary tract infection 7. History of hysterectomy,mid-urethral sling,pelvic organ prolapse repair,vaginal delivery or Cesarean section,prostate operation or treatment etc within 6months. 8. Neurologic disease history of cerebral infarction,multiple sclerosis or parkinsonism etc.- 9. Using a indwelling catheter or execution of intermittent self catheterization
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
South Korea
Outcome results
None listed