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

July 2, 2019 updated by: Myung-Soo Choo, Asan Medical Center

Experimental Study of Biomarker in Patient With Interstitial Cystitis/Painful Bladder

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

Study Overview

Status

Completed

Conditions

Detailed Description

This is a observational study

Study Type

Observational

Enrollment (Actual)

67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-222
        • Asan Medical Center
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center Institutional Review Board

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients >20 years old with interstitial cystitis control

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control
Hunner's ulcer interstitial cystitis
non-ulcer interstitial cystitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare of changes voiding parameters after bladder biopsy between Hunner' ulcer group and non-ulcer group
Time Frame: 1 month
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
Time Frame: 1month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Myung-Soo Choo, M.D., Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2013

Primary Completion (Actual)

May 12, 2016

Study Completion (Actual)

May 12, 2016

Study Registration Dates

First Submitted

November 10, 2013

First Submitted That Met QC Criteria

November 10, 2013

First Posted (Estimate)

November 15, 2013

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 2, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-0616

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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