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OpenTrials
Completed

NCT Number: NCT03468530

Therapeutic Effects of Endoscopic Ablation of Hunner Lesions in Interstitial Cystitis/ Bladder Pain Syndrome Patients

efficacy of endoscopic ablation of Hunner lesions in patients with IC/BPS and the characteristics of HLs based on a long-term follow-up

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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

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, 135-710, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female aged 18 yrs or greater
  • Patients diagnosed with BPS(Bladder Pain Syndrome)
  • Symptom persisted more than 6 months
  • Pain VAS ≥4
  • O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) scores 12 or greater with pain and nocturia domain scores > 2.
  • Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF) >13
  • No history of cystoscopy within 2yrs.

Exclusion criteria

  • History of augmentation cystoplasty or previous transurethral coagulation/resection due to BPS
  • Child-bearing potential, pregnant or nursing women.
  • Mean voided volume lesser than 40ml or over than 400ml.
  • Hematuria exceeds 1+ in the urinary dipstick (dipstick) examination.
  • Urinary tract infection during run-in periods.
  • Genitourinary tuberculosis or bladder,urethral and prostate cancer
  • Recurrent urinary tract infection
  • History of hysterectomy,mid-urethral sling,pelvic organ prolapse repair,vaginal delivery or Cesarean section,prostate operation or treatment etc within 6months.
  • Neurologic disease history of cerebral infarction,multiple sclerosis or parkinsonism etc.-

Treatment and study plan

Transurethral ablation

Procedure

transurethral resection and/or coagulation with a bipolar loop under spinal or general anesthesia

Primary outcomes

  1. change in recurrence-free survival time after ablation treatment

    Time frame: Every three months for one year

Secondary outcomes

  1. changes in mean number of daytime frequency episodes

    Time frame: Every three months for one year

  2. changes in mean number of nocturia episodes

    Time frame: Every three months for one year

  3. changes in mean number of urgency episodes

    Time frame: Every three months for one year

  4. Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)

    Time frame: Every three months for one year

  5. Score of Global Response Assessment (GRA), Patient Global Assessment (PGA) score

    Time frame: every 3months for one year

  6. Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF)

    Time frame: Every three months for one year

  7. Change score of Brief Pain Inventory-short form (BPI-sf)

    Time frame: Every three months for one year

  8. Occurrence of adverse event

    Time frame: Every three months for one year

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2025
First posted
Mar 16, 2018
Registry last updated
Jul 22, 2025

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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