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

Interstitial Cystitis Clinical Trial

Official title:

Experimental Study of Biomarker in Patient With Interstitial Cystitis/Painful Bladder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01985880
• Other study ID #: 2013-0616
• Status: Completed
• Start date: November 19, 2013
• Est. completion date: May 12, 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

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

Description:

This is a observational study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: May 12, 2016
• Est. primary completion date: May 12, 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 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

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis

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	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	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
Secondary	To compare of changes voiding parameters after bladder biopsy between Hunner' ulcer group and non-ulcer group	To compare of changes voiding parameters after bladder biopsy between Hunner' ulcer group and non-ulcer group	1 month
Secondary	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	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