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

Interstitial Cystitis Clinical Trial

Official title:

Longitudinal Change of Distribution Pattern of Hunner's Ulcer in Patient With Interstitial Cystitis/Bladder Pain Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02150811
• Other study ID #: 20131119
• Status: Completed
• Start date: June 2, 2016
• Est. completion date: January 31, 2017

Study information

• Verified date: July 2019
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

This is observational, 12 months study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 31, 2017
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of distribution pattern of Hunner's ulcer		1 month, 6month, 12month