Interstitial Cystitis
Conditions
Brief summary
efficacy of endoscopic ablation of Hunner lesions in patients with IC/BPS and the characteristics of HLs based on a long-term follow-up
Interventions
PROCEDURETransurethral ablation
transurethral resection and/or coagulation with a bipolar loop under spinal or general anesthesia
Sponsors
Samsung Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female aged 18 yrs or greater 2. Patients diagnosed with BPS(Bladder Pain Syndrome) 3. Symptom persisted more than 6 months 4. Pain VAS ≥4 5. O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) scores 12 or greater with pain and nocturia domain scores \> 2. 6. Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF) \>13 7. No history of cystoscopy within 2yrs.
Exclusion criteria
1. History of augmentation cystoplasty or previous transurethral coagulation/resection due to BPS 2. Child-bearing potential, pregnant or nursing women. 3. Mean voided volume lesser than 40ml or over than 400ml. 4. Hematuria exceeds 1+ in the urinary dipstick (dipstick) examination. 5. Urinary tract infection during run-in periods. 6. Genitourinary tuberculosis or bladder,urethral and prostate cancer 7. Recurrent urinary tract infection 8. History of hysterectomy,mid-urethral sling,pelvic organ prolapse repair,vaginal delivery or Cesarean section,prostate operation or treatment etc within 6months. 9. Neurologic disease history of cerebral infarction,multiple sclerosis or parkinsonism etc.-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in recurrence-free survival time after ablation treatment | Every three months for one year |
Secondary
| Measure | Time frame |
|---|---|
| changes in mean number of nocturia episodes | Every three months for one year |
| changes in mean number of urgency episodes | Every three months for one year |
| Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) | Every three months for one year |
| changes in mean number of daytime frequency episodes | Every three months for one year |
| Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF) | Every three months for one year |
| Change score of Brief Pain Inventory-short form (BPI-sf) | Every three months for one year |
| Occurrence of adverse event | Every three months for one year |
| Score of Global Response Assessment (GRA), Patient Global Assessment (PGA) score | every 3months for one year |
Countries
South Korea
Outcome results
None listed