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

NCT02331472 | Completed DMC

• 1 other identifier: 2014-1220
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Chronic Interstitial Cystitis

Keywords

interstitial cystitis; biomarker

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

  1day

Study Arms (2)

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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Interstitial cystitis

You may qualify if:

• must have experienced bladder pain, urinary urgency and frequency for at least 6 months prior to entry into the study
• Pain VAS \>4
• PUF score \>13
• ICQ score \>12
• \) cystoscopic record within 2years

You may not qualify if:

• Patients who are pregnancy or, childbearing age without no contraception
• Patient with microscopic hematuria, if not excluded that no evidence of neoplastic tumor examination
• patients with urine culture showing evidence of urinary tract infection 1month prior to the study
• Accompanied medical problem below
• Tuberculosis in urinary system
• Bladder cancer, urethral cancer, Prostate cancer
• Recurrent cystitis
• Anatomical disorder
• Patients had prior surgery (bladder augmentation, cystectomy)
• Patients with neurologic disorder
• Patients with indwelling catheter or intermittent self-catheterization
• Patients with psychological problem

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (2)

Asan Medical Center

Seoul, 138-222, South Korea

Location

Asan medical center Institutional review board

Seoul, 138-736, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

RNA in urine specimen

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Myung-Soo Choo, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 1, 2015
• First Posted: January 6, 2015
• Study Start: February 3, 2015
• Primary Completion: January 14, 2016
• Study Completion: January 14, 2016
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)