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Completed

NCT Number: NCT02150811

Observational Study of Hunner's Ulcer in Patient With Interstitial Cystitis/Bladder Pain Syndrome

The purpose of this study is to observe change of distribution pattern of Hunner's ulcer in patient with interstitial cystitis/bladder pain 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, 138-736, South Korea

About this study

This is observational, 12 months study

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • must have experienced bladder pain, urinary urgency and urinary frequency, for at least 6 months prior to entry into the study
  • Pain VAS ≥4
  • O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) symptom and problem ≥ 12( and pain ≥2, and nocturia ≥ 2)
  • PUF score ≥ 13
  • cystoscopic record within 2 years
  • Hunner ulcer lesion in cystoscopic finding

Exclusion criteria

  • Scheduled for or use of intravesical therapy (eg, bladder distention,transurethral resection of bladder ulcer, instillation) during or within 6months prior to the study and use of pentosan polysulfate sodium within 1 months prior to the study
  • 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. Change of distribution pattern of Hunner's ulcer

    Time frame: 1 month, 6month, 12month

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

Longitudinal Change of Distribution Pattern of Hunner's Ulcer in Patient With Interstitial Cystitis/Bladder Pain Syndrome

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 30, 2014
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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