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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
Myung-Soo Choo, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01985880
First received: November 10, 2013
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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


Condition
Interstitial Cystitis

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Experimental Study of Biomarker in Patient With Interstitial Cystitis/Painful Bladder

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • 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 [ Time Frame: 1month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare of changes voiding parameters after bladder biopsy between Hunner' ulcer group and non-ulcer group [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: 1month ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

bladder biopsy, urine, blood


Estimated Enrollment: 10
Study Start Date: November 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hunner's ulcer interstitial cystitis
Hunner's ulcer interstitial cystitis
non-ulcer interstitial cystitis
non-ulcer interstitial cystitis
Control
Control

Detailed Description:

This is a observational study

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

patients >20 years old with interstitial cystitis control

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01985880

Contacts
Contact: Myung-Soo Choo, M.D. 82-2-3010-3735 ext No mschoo@amc.seoul.kr

Locations
Korea, Republic of
Asan medical center Institutional review board Recruiting
Seoul, Korea, Republic of, 138-736
Contact    82-2-3010-7166 ext No    irb@amc.seoul.kr   
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Myung-Soo Choo, M.D. Asan Medical Center
  More Information

No publications provided

Responsible Party: Myung-Soo Choo, M.D., Asan Medical Center
ClinicalTrials.gov Identifier: NCT01985880     History of Changes
Other Study ID Numbers: 2013-0616
Study First Received: November 10, 2013
Last Updated: May 28, 2014
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 20, 2014