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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01985880
Enrollment
67
Registered
2013-11-15
Start date
2013-11-19
Completion date
2016-05-12
Last updated
2019-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Cystitis

Keywords

Biomarkers

Brief summary

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

Detailed description

This is a observational study

Interventions

None listed

Sponsors

Asan Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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 groups1monthTo 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

Secondary

MeasureTime frameDescription
To compare of changes voiding parameters after bladder biopsy between Hunner' ulcer group and non-ulcer group1 monthTo compare of changes voiding parameters after bladder biopsy between Hunner' ulcer group and non-ulcer group
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 group1monthTO 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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026