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

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

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

Conditions
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Interstitial Cystitis

Intervention / Treatment
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* Procedure: Transurethral ablation


Participation Criteria
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Eligibility Criteria
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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.-

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Transurethral ablation|transurethral resection and/or coagulation with a bipolar loop under spinal or general anesthesia|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in recurrence-free survival time after ablation treatment |  | Every three months for one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in mean number of daytime frequency episodes |  | Every three months for one year | 
| changes in mean number of nocturia episodes |  | Every three months for one year | 
| changes in mean number of urgency episodes |  | Every three months for one year | 
| Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) |  | Every three months for one year | 
| Score of Global Response Assessment (GRA), Patient Global Assessment (PGA) score |  | every 3months for one year | 
| Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF) |  | Every three months for one year | 
| Change score of Brief Pain Inventory-short form (BPI-sf) |  | Every three months for one year | 
| Occurrence of adverse event |  | Every three months for one year |