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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02331472

Enrollment

Registered

2015-01-06

Start date

2015-02-03

Completion date

2016-01-14

Last updated

2019-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Interstitial Cystitis

Keywords

interstitial cystitis, biomarker

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Difference of RNA expression of the urine biomarker between the interstitial cystitis and control groups	1day	Difference of RNA expression of the urine biomarker between the interstitial cystitis and control groups

Secondary

Measure	Time frame	Description
Difference of RNA expression of the urine biomarker between Hunner ulcer interstitial cystitis and non-ulcer interstitial cystitis groups	1day	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 in interstitial cystitis according to pain score on the visual analogue scale	1day	Difference of RNA expression of the urine biomarker in interstitial cystitis according to pain score on the visual analogue scale

Countries

South Korea

Outcome results