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

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ClinicalTrials.gov Identifier: NCT02331472
Recruitment Status : Recruiting
First Posted : January 6, 2015
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Myung-Soo Choo, Asan Medical Center

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

Condition or disease
Chronic Interstitial Cystitis

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Month
Official Title: The Efficacy of Urine Biomarker in Patient With Interstitial Cystitis/Painful Bladder Syndrome
Study Start Date : January 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Interstitial cystitis
Contral



Primary Outcome Measures :
  1. Difference of RNA expression of the urine biomarker between the interstitial cystitis and control groups [ Time Frame: 1day ]

Secondary Outcome Measures :
  1. Difference of RNA expression of the urine biomarker between Hunner ulcer interstitial cystitis and non-ulcer interstitial cystitis groups [ Time Frame: 1day ]
  2. Difference of RNA expression of the urine biomarker in interstitial cystitis according to pain score on the visual analogue scale [ Time Frame: 1day ]

Biospecimen Retention:   Samples With DNA
RNA in urine specimen


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:   Probability Sample
Study Population
Interstitial cystitis
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT02331472


Locations
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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    mschoo@amc.seoul.kr   
Contact: Miho Song, M.D.    +82-2-3010-1768    aengdunamu@hanmail.net   
Sub-Investigator: Miho Song, M.D.         
Sponsors and Collaborators
Asan Medical Center

Additional Information:

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Responsible Party: Myung-Soo Choo, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02331472     History of Changes
Other Study ID Numbers: 2014-1220
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017

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

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