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

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

Study Overview

• Status: Completed
• Conditions: Chronic Interstitial Cystitis

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 138-222
    • Asan Medical Center
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center Institutional Review Board

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Interstitial cystitis

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Interstitial cystitis; Patients who have been diagnosed with interstitial cystitis/bladder pain syndrome. The group includes both patients with or without Hunner lesion on cystoscopy
Control; Adult participants without history of interstitial cystitis/bladder pain syndrome

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Principal Investigator: Myung-Soo Choo, MD, PhD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2015
• Primary Completion (Actual): January 14, 2016
• Study Completion (Actual): January 14, 2016

Study Registration Dates

• First Submitted: January 1, 2015
• First Submitted That Met QC Criteria: January 4, 2015
• First Posted (Estimate): January 6, 2015

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: biomarker; interstitial cystitis
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Cystitis; Cystitis, Interstitial
• Other Study ID Numbers: 2014-1220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO