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Trial record 3 of 158 for:    interstitial cystitis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01985880
Recruitment Status : Recruiting
First Posted : November 15, 2013
Last Update Posted : January 16, 2018
Information provided by (Responsible Party):
Myung-Soo Choo, Asan Medical Center

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

Condition or disease
Interstitial Cystitis

Detailed Description:
This is a observational study

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Experimental Study of Biomarker in Patient With Interstitial Cystitis/Painful Bladder
Study Start Date : November 2013
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Hunner's ulcer interstitial cystitis
Hunner's ulcer interstitial cystitis
non-ulcer interstitial cystitis
non-ulcer interstitial cystitis

Primary Outcome Measures :
  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 [ Time Frame: 1month ]

Secondary Outcome Measures :
  1. To compare of changes voiding parameters after bladder biopsy between Hunner' ulcer group and non-ulcer group [ Time Frame: 1 month ]
  2. 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 ]

Biospecimen Retention:   Samples With DNA
bladder biopsy, urine, blood

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients >20 years old with interstitial cystitis control

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01985880

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Contact: Myung-Soo Choo, M.D. 82-2-3010-3735

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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-222
Contact: Myung-Soo Choo, M.D, pH.D.    +82-2-3010-3735   
Contact: Miho Song, M.D.    +82-2-3010-1768   
Sub-Investigator: Miho Song, M.D.         
Asan medical center Institutional review board Recruiting
Seoul, Korea, Republic of, 138-736
Contact    82-2-3010-7166   
Sponsors and Collaborators
Asan Medical Center
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Principal Investigator: Myung-Soo Choo, M.D. Asan Medical Center

Additional Information:

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Responsible Party: Myung-Soo Choo, M.D., Asan Medical Center Identifier: NCT01985880     History of Changes
Other Study ID Numbers: 2013-0616
First Posted: November 15, 2013    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018

Keywords provided by Myung-Soo Choo, Asan Medical Center:

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