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Completed

NCT Number: NCT01985880

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

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

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Key information

Conditions

Interstitial Cystitis Cystitis Cystitis, Interstitial Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center, Seoul, South Korea

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About this study

This is a observational study

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • Patients who are pregnancy or, childbearing age without no contraception
  • Patients with voided volume <40 or, > 400ml
  • Patients with microscopic hematuria, (≥1+ in dipstick), If not excluded that no evidence of neoplastic tumor examination
  • Patients with urine culture showing evidence of urinary tract infection 1month prior to the study
  • Accompanied medical problem below
  • Tuberculosis in urinary system
  • Bladder cancer, urethral cancer, prostate cancer
  • Recurrent cystitis
  • anatomical disorder
  • Patients had prior surgery (eq, bladder augmentation, cystectomy
  • Patients with neurologic disorder
  • Patients with indwelling catheter or intermittent self-catheterization
  • Patients with psychologic problem

Treatment and study plan

Primary outcomes

  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

    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

Secondary outcomes

  1. 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

  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

    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

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 15, 2013
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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