Bladder Pain Syndrome
Conditions
Keywords
Bladder Pain Syndrome, Transurethral Resection of Ulcer, Transurethral Coagulation of Ulcer
Brief summary
On the EAU (European Association of Urology) guidelines, the ulcer type bladder pain syndrome (BPS) should be treated with transurethral resection (TUR) or coagulation (TUC) of ulcer. But, Up to date, there was no study to compare the therapeutic efficacy of TUR with TUC in ulcer type BPS patients. We assume TUR have a more therapeutic effect than TUC.
Interventions
PROCEDURETransurethral Coagulation (TUC)
PROCEDURETransurethral Resection(TUR)
Sponsors
Samsung Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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 |
|---|---|
| Recurrence-free survival between TUC and TUR | Until 12 months after the last subject be enrolled |
Secondary
| Measure | Time frame |
|---|---|
| The change of Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) | 1,3,6,9 and 12months. |
| The change of Global Response Assessment(GRA) score | 1,3,6,9 and 12 months |
| The change of voiding dairy parameters(mean number of micturition,Urgency etc) after each treatment | 1,3,6,9 and 12 months |
| The change of Patient Global Assessment(PGA) | 12months |
| The change of Brief Pain Inventory-short form(BPI-sf) score | 9 and 12months |
| The change of EQ-5D (EuroQOL five dimensions) Health Questionnaire score | 1,3,6,9 and 12months |
Countries
South Korea
Outcome results
None listed