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

NCT ID: NCT01985880

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 67 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-19
• Study Completion Date: 2016-05-12

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

Conditions

Interstitial Cystitis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Hunner's ulcer interstitial cystitis

Hunner's ulcer interstitial cystitis

No interventions assigned to this group

non-ulcer interstitial cystitis

non-ulcer interstitial cystitis

No interventions assigned to this group

Control

Control

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Myung-Soo Choo

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Myung-Soo Choo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, , South Korea

Asan medical center Institutional review board

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2013-0616

Identifier Type: -

Identifier Source: org_study_id