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

NCT ID: NCT02331472

Last Updated: 2019-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-03

Study Completion Date

2016-01-14

Brief Summary

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

Detailed Description

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Conditions

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Chronic Interstitial Cystitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Interstitial cystitis

Patients who have been diagnosed with interstitial cystitis/bladder pain syndrome. The group includes both patients with or without Hunner lesion on cystoscopy

No interventions assigned to this group

Control

Adult participants without history of interstitial cystitis/bladder pain syndrome

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Myung-Soo Choo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Myung-Soo Choo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Asan medical center Institutional review board

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2014-1220

Identifier Type: -

Identifier Source: org_study_id

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