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

Completed

• Conditions: Interstitial Cystitis

• Registration Number: NCT01985880
• Lead Sponsor: Asan Medical Center

Brief Summary

The purpose of this study is to evaluate efficacy of biomarker in patient with interstitial cystitis/painful bladder syndrome

Detailed Description

This is a observational study

Study Timeline

• Study First Submitted: 2013-11-10
• Study First Submitted QC: 2013-11-10
• Study First Posted: 2013-11-15
• Study Start: 2013-11-19
• Primary Completion: 2016-05-12
• Study Completion: 2016-05-12
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Exclusion Criteria

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

2. Patients with voided volume <40 or, > 400ml

3. Patients with microscopic hematuria, (≥1+ in dipstick), If not excluded that no evidence of neoplastic tumor examination

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

5. Accompanied medical problem below

   • Tuberculosis in urinary system
   • Bladder cancer, urethral cancer, prostate cancer
   • Recurrent cystitis
   • anatomical disorder

6. Patients had prior surgery (eq, bladder augmentation, cystectomy

7. Patients with neurologic disorder

8. Patients with indwelling catheter or intermittent self-catheterization

9. Patients with psychologic problem

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare of expression of the biomarker such as APF, HB-EGF, MCP-1 among the Hunner's ulcer interstitial cystitis and non-ulcer interstitial cystitis and control groups	1month	To compare of expression of the biomarker such as APF, HB-EGF, MCP-1 among the Hunner's ulcer interstitial cystitis and non-ulcer interstitial cystitis and control groups

Secondary Outcome Measures

Name	Time	Method
To compare of changes voiding parameters after bladder biopsy between Hunner' ulcer group and non-ulcer group	1 month	To compare of changes voiding parameters after bladder biopsy between Hunner' ulcer group and non-ulcer group
TO compare of change of scores of questionnaires such as O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q), Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF), Visual Analogue Scale (Pain) between Hunner's ulcer group and non-ulcer group	1month	TO compare of change of scores of questionnaires such as O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q), Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF), Visual Analogue Scale (Pain) between Hunner's ulcer group and non-ulcer group

Trial Locations

Locations (2)

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

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