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

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Samsung Medical Center

Status

Completed

Conditions

Interstitial Cystitis

Treatments

Procedure: Transurethral ablation

Study type

Observational

Funder types

Other

Identifiers

NCT03468530
2017-08-005

Details and patient eligibility

About

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

Enrollment

442 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial contacts and locations

1

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Central trial contact

Kwang Jin Ko, Ph.D.

Data sourced from clinicaltrials.gov

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