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

NCT01985880 | Completed DMC

• 1 other identifier: 2013-0616
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Interstitial Cystitis

Keywords

Biomarkers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  1 month

• 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

Study Arms (3)

Hunner's ulcer interstitial cystitis

Hunner's ulcer interstitial cystitis

non-ulcer interstitial cystitis

non-ulcer interstitial cystitis

Control

Control

Eligibility Criteria

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

Study Population

patients \>20 years old with interstitial cystitis control

You may qualify if:

• \) 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

You may not qualify if:

• Patients who are pregnancy or, childbearing age without no contraception
• Patients with voided volume \<40 or, \> 400ml
• Patients with microscopic hematuria, (≥1+ in dipstick), 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 (eq, bladder augmentation, cystectomy
• Patients with neurologic disorder
• Patients with indwelling catheter or intermittent self-catheterization
• Patients with psychologic 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

bladder biopsy, urine, blood

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, M.D.

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: November 10, 2013
• First Posted: November 15, 2013
• Study Start: November 19, 2013
• Primary Completion: May 12, 2016
• Study Completion: May 12, 2016
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)