Comparison of the Efficacy Between Transurethral Coagulation and Transurethral Resection of Ulcer in Bladder Pain Syndrome Patients

Study Overview
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Brief Summary
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On the EAU (European Association of Urology) guidelines, the ulcer type bladder pain syndrome (BPS) should be treated with transurethral resection (TUR) or coagulation (TUC) of ulcer. But, Up to date, there was no study to compare the therapeutic efficacy of TUR with TUC in ulcer type BPS patients. We assume TUR have a more therapeutic effect than TUC.

Official Title
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Pilot Study for Comparison of the Efficacy Between Transurethral Coagulation and Transurethral Resection of Ulcer in Bladder Pain Syndrome Patients

Conditions
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Bladder Pain Syndrome

Intervention / Treatment
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* Procedure: Transurethral Coagulation (TUC)
* Procedure: Transurethral Resection(TUR)


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
Maximum Age: 90 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Transurethral Coagulation (TUC)<br>This cohort patients will be managed with Transurethral Coagulation (TUC) of IC ulcer lesion | Procedure: Transurethral Coagulation (TUC)<br> <br> |
| Transurethral Resection(TUR)<br>This cohort patients will be managed with transurethral resection(TUR) of IC ulcer lesion | Procedure: Transurethral Resection(TUR)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-free survival between TUC and TUR |  | Until 12 months after the last subject be enrolled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of voiding dairy parameters(mean number of micturition,Urgency etc) after each treatment |  | 1,3,6,9 and 12 months | 
| The change of Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) |  | 1,3,6,9 and 12months. | 
| The change of Global Response Assessment(GRA) score |  | 1,3,6,9 and 12 months | 
| The change of EQ-5D (EuroQOL five dimensions) Health Questionnaire score |  | 1,3,6,9 and 12months | 
| The change of Patient Global Assessment(PGA) |  | 12months | 
| The change of Brief Pain Inventory-short form(BPI-sf) score |  | 9 and 12months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bladder Pain Syndrome, Transurethral Resection of Ulcer, Transurethral Coagulation of Ulcer