Observational Study of Hunner's Ulcer in Patient With Interstitial Cystitis/Bladder Pain Syndrome

Asan Medical Center

Status: Completed

Conditions: Interstitial Cystitis

Study type: Observational

Funder types: Other

Identifiers

NCT02150811

20131119

Details and patient eligibility

About

The purpose of this study is to observe change of distribution pattern of Hunner's ulcer in patient with interstitial cystitis/bladder pain syndrome

Full description

This is observational, 12 months study

Enrollment: 40 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 1 patient group

Hunner's ulcer