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

Completed

• Conditions: Chronic Interstitial Cystitis

• Registration Number: NCT02331472
• Lead Sponsor: Asan Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-01
• Study First Submitted QC: 2015-01-04
• Study First Posted: 2015-01-06
• Study Start: 2015-02-03
• Primary Completion: 2016-01-14
• Study Completion: 2016-01-14
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Asan medical center Institutional review board; 🇰🇷 Seoul, Korea, Republic of