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Completed

NCT Number: NCT02331472

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

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

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Key information

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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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • must have experienced bladder pain, urinary urgency and frequency for at least 6 months prior to entry into the study
  • Pain VAS >4
  • PUF score >13
  • ICQ score >12
  • cystoscopic record within 2years

Exclusion criteria

  • Patients who are pregnancy or, childbearing age without no contraception
  • Patient with microscopic hematuria, 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 (bladder augmentation, cystectomy)
  • Patients with neurologic disorder
  • Patients with indwelling catheter or intermittent self-catheterization
  • Patients with psychological problem

Treatment and study plan

Primary outcomes

  1. Difference of RNA expression of the urine biomarker between the interstitial cystitis and control groups

    Time frame: 1day

    Difference of RNA expression of the urine biomarker between the interstitial cystitis and control groups

Secondary outcomes

  1. Difference of RNA expression of the urine biomarker between Hunner ulcer interstitial cystitis and non-ulcer interstitial cystitis groups

    Time frame: 1day

    Difference of RNA expression of the urine biomarker between Hunner ulcer interstitial cystitis and non-ulcer interstitial cystitis groups

  2. Difference of RNA expression of the urine biomarker in interstitial cystitis according to pain score on the visual analogue scale

    Time frame: 1day

    Difference of RNA expression of the urine biomarker in interstitial cystitis according to pain score on the visual analogue scale

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 6, 2015
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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