The Efficacy of Urine Biomarker in Patient With Interstitial Cystitis/Painful Bladder Syndrome (Pilot Study)

Chronic Interstitial Cystitis Clinical Trial

Official title:

The Efficacy of Urine Biomarker in Patient With Interstitial Cystitis/Painful Bladder Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02331472
• Other study ID #: 2014-1220
• Status: Completed
• Start date: February 3, 2015
• Est. completion date: January 14, 2016

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

This study is to evaluate the efficacy of urine biomarker in patients with interstitial cystitis/painful bladder syndrome

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 14, 2016
• Est. primary completion date: January 14, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. must have experienced bladder pain, urinary urgency and frequency for at least 6 months prior to entry into the study

2. Pain VAS >4

3. PUF score >13

4. ICQ score >12

4) cystoscopic record within 2years

Exclusion Criteria:

1. Patients who are pregnancy or, childbearing age without no contraception

2. Patient with microscopic hematuria, if not excluded that no evidence of neoplastic tumor examination

3. patients with urine culture showing evidence of urinary tract infection 1month prior to the study

4. Accompanied medical problem below

• Tuberculosis in urinary system

• Bladder cancer, urethral cancer, Prostate cancer

• Recurrent cystitis

• Anatomical disorder

5. Patients had prior surgery (bladder augmentation, cystectomy)

6. Patients with neurologic disorder

7. Patients with indwelling catheter or intermittent self-catheterization

8. Patients with psychological problem

Related Conditions & MeSH terms

• Chronic Interstitial Cystitis
• Cystitis
• Cystitis, Interstitial

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Asan medical center Institutional review board	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	Difference of RNA expression of the urine biomarker between the interstitial cystitis and control groups	Difference of RNA expression of the urine biomarker between the interstitial cystitis and control groups	1day
Secondary	Difference of RNA expression of the urine biomarker between Hunner ulcer interstitial cystitis and non-ulcer interstitial cystitis groups	Difference of RNA expression of the urine biomarker between Hunner ulcer interstitial cystitis and non-ulcer interstitial cystitis groups	1day
Secondary	Difference of RNA expression of the urine biomarker in interstitial cystitis according to pain score on the visual analogue scale	Difference of RNA expression of the urine biomarker in interstitial cystitis according to pain score on the visual analogue scale	1day