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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-12-007-001 | Other Identifier | Ewha Womans University Mokdong Hospital |
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| Name | Class |
|---|---|
| Ewha Womans University Mokdong Hospital | OTHER |
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This study is a randomized controlled trial. Subject population is adult patients with Hunner-type interstitial cystitis. The objective of this study is to compare the therapeutic effect between the two surgical modality; TUF (transurethral fulguration of the Hunner lesion) versus TUF+HD(addition of bladder hydrodistension prior to transurethral fulguration of the Hunner lesion).
Subject patients are randomly allocated to 1:1 ratio using Permuted block randomization. For TUF group, only fulguration on the Hunner lesion is performed. For TUF+HD group hydrodistension is performed for 8 minutes at pressure of 80cmH2O, and then fulguration on the Hunner lesion is performed. Therapeutic effect is evaluated using Visual Analogue Scale (VAS) pain score, O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q), Pelvic pain urgency/frequency patient symptom scale (PUF), frequency volume chart parameters, EQ-5D Health Questionnaire, Brief Pain Inventory-short form (BPI-sf), Patient Global Assessment (PGA) at the point of 1, 2, 4 and 6 months after operation. During the observational period, subject patients are not provided with any additional medical, physical or surgical treatment for symptom relief. Subject patient who complains of symptom requiring medical, physical or surgical intervention during the study period, is dropped from the study. Comparison of therapeutic efficacy between the two groups is performed using independent two sample t-test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TUF | Placebo Comparator | Subjects allocated into TUF+HD group receive bladder hydrodistension prior to transurethral fulguration of Hunner lesion |
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| TUF+HD | Experimental | Subjects allocated into TUF+HD group receive bladder hydrodistension prior to transurethral fulguration of Hunner lesion |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transurethral fulguration of the Hunner lesion | Procedure | Hunner lesion of the bladder is fulgurated with electronic surgical device under cystoscopic inspection. For the intervention, general or spinal anesthesia is required. |
| Measure | Description | Time Frame |
|---|---|---|
| inter-group difference of VAS pain score at postoperative one month | Primary end-point is inter-group difference of VAS pain score at postoperative one month. Analysis is performed based on independent two sample t-test. ; About the VAS pain score -'VAS' is abbreviation of 'Visual Analogue Scale'. For evaluation of pain, we use 'Visual Analogue Scale' which has a range from 0 to 10 points. The score increases depending on the severity of the pain symptoms. | at postoperative one month |
| Measure | Description | Time Frame |
|---|---|---|
| inter-group differences in drop-out rate at postoperative 6 months | Assessment of Drop-out rate is performed at the point of postoperative 6 months (both using the Intention-To-Treat and Per-Protocol analysis) | at postoperative 6 months |
| inter-group differences in O'Leary-Sant Interstitial Cystitis-Questionnaires |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology and Urological Science Institute, Yonsei University College of Medicine | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29777618 | Background | Malde S, Palmisani S, Al-Kaisy A, Sahai A. Guideline of guidelines: bladder pain syndrome. BJU Int. 2018 Nov;122(5):729-743. doi: 10.1111/bju.14399. Epub 2018 Jun 13. | |
| 29566264 | Background | Kirk PS, Santiago-Lastra Y, Qin Y, Stoffel JT, Clemens JQ, Cameron AP. The effects of cystoscopy and hydrodistention on symptoms and bladder capacity in interstitial cystitis/bladder pain syndrome. Neurourol Urodyn. 2018 Aug;37(6):2002-2007. doi: 10.1002/nau.23555. Epub 2018 Mar 22. |
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Currently, we do not plan to share patient data with third parties.
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1:1 allocation with Permuted block randomization
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| Combination treatment of bladder hydrodistension and transurethral fulguration of the Hunner lesion | Procedure | Prior to Hunner lesion fulguration, bladder hydrodistension is performed for 8 minutes at pressure of 80cmH2O. And then transurethral fulguration is performed on the Hunner lesion. |
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O'Leary-Sant questionnaire assesses severity of symptoms on the bladder pain, frequency, urgency, nocturia, composed of symptom index and problem index |
| at postoperative 1 month |
| inter-group differences in O'Leary-Sant Interstitial Cystitis-Questionnaires | O'Leary-Sant questionnaire assesses severity of symptoms on the bladder pain, frequency, urgency, nocturia, composed of symptom index and problem index | at postoperative 2 months |
| inter-group differences in O'Leary-Sant Interstitial Cystitis-Questionnaires | O'Leary-Sant questionnaire assesses severity of symptoms on the bladder pain, frequency, urgency, nocturia, composed of symptom index and problem index | at postoperative 4 months |
| inter-group differences in O'Leary-Sant Interstitial Cystitis-Questionnaires | O'Leary-Sant questionnaire assesses severity of symptoms on the bladder pain, frequency, urgency, nocturia, composed of symptom index and problem index | at postoperative 6 months |
| inter-group differences in PUF(Pelvic pain and Urgency/Frequency patient symptom scale) | PUF (Pelvic pain and Urgency/Frequency patient symptom scale) is questionnaire which evaluates symptoms of pain, urgency, and frequency and how much they bother the patient. PUF (Pelvic pain and Urgency/Frequency patient symptom scale) is composed of two compartment; symptom score (7 items) and bother score (4 items). The symptom scores range from 2~23 points and the symptom scores range from 0~12 points. The higher the score, the worse the symptoms. | at postoperative 1 month |
| inter-group differences in PUF(Pelvic pain and Urgency/Frequency patient symptom scale) | PUF (Pelvic pain and Urgency/Frequency patient symptom scale) is questionnaire which evaluates symptoms of pain, urgency, and frequency and how much they bother the patient. PUF (Pelvic pain and Urgency/Frequency patient symptom scale) is composed of two compartment; symptom score (7 items) and bother score (4 items). The symptom scores range from 2~23 points and the symptom scores range from 0~12 points. The higher the score, the worse the symptoms. | at postoperative 2 months |
| inter-group differences in PUF(Pelvic pain and Urgency/Frequency patient symptom scale) | PUF (Pelvic pain and Urgency/Frequency patient symptom scale) is questionnaire which evaluates symptoms of pain, urgency, and frequency and how much they bother the patient. PUF (Pelvic pain and Urgency/Frequency patient symptom scale) is composed of two compartment; symptom score (7 items) and bother score (4 items). The symptom scores range from 2~23 points and the symptom scores range from 0~12 points. The higher the score, the worse the symptoms. | at postoperative 4 months |
| inter-group differences in PUF(Pelvic pain and Urgency/Frequency patient symptom scale) | PUF (Pelvic pain and Urgency/Frequency patient symptom scale) is questionnaire which evaluates symptoms of pain, urgency, and frequency and how much they bother the patient. PUF (Pelvic pain and Urgency/Frequency patient symptom scale) is composed of two compartment; symptom score (7 items) and bother score (4 items). The symptom scores range from 2~23 points and the symptom scores range from 0~12 points. The higher the score, the worse the symptoms. | at postoperative 6 months |
| inter-group differences in EQ-5D Health Questionnaire | The EQ-5D questionnaire is a tool for brief evaluation of subject's health status. The EQ-5D questionnaire has five dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item has three-level; having no problems, having some or moderate problems, being unable to do/having extreme problems. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number. The 5-digit number is finally converted to a single summary index by a specific formula. | at postoperative 1 month |
| inter-group differences in EQ-5D Health Questionnaire | The EQ-5D questionnaire is a tool for brief evaluation of subject's health status. The EQ-5D questionnaire has five dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item has three-level; having no problems, having some or moderate problems, being unable to do/having extreme problems. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number. The 5-digit number is finally converted to a single summary index by a specific formula. | at postoperative 2 months |
| inter-group differences in EQ-5D Health Questionnaire | The EQ-5D questionnaire is a tool for brief evaluation of subject's health status. The EQ-5D questionnaire has five dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item has three-level; having no problems, having some or moderate problems, being unable to do/having extreme problems. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number. The 5-digit number is finally converted to a single summary index by a specific formula. | at postoperative 4 months |
| inter-group differences in EQ-5D Health Questionnaire | The EQ-5D questionnaire is a tool for brief evaluation of subject's health status. The EQ-5D questionnaire has five dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item has three-level; having no problems, having some or moderate problems, being unable to do/having extreme problems. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number. The 5-digit number is finally converted to a single summary index by a specific formula. | at postoperative 6 months |
| Brief Pain Inventory-short form (BPI-sf) | Brief Pain Inventory-short form (BPI-sf) is composed of two domains measured by the "pain severity" and the "pain interference", Pain severity compartment is composed of 4 items, and pain interference compartment is composed of 7 items (of 24-hour recall period). Each item has 0-10 scales. Brief pain severity score is calculated by adding the scores of 4 questions and then dividing by 4. Brief pain interference score is calculated by adding the scores for 7 questions and then dividing by 7. | at postoperative 1 month |
| Brief Pain Inventory-short form (BPI-sf) | Brief Pain Inventory-short form (BPI-sf) is composed of two domains measured by the "pain severity" and the "pain interference", Pain severity compartment is composed of 4 items, and pain interference compartment is composed of 7 items (of 24-hour recall period). Each item has 0-10 scales. Brief pain severity score is calculated by adding the scores of 4 questions and then dividing by 4. Brief pain interference score is calculated by adding the scores for 7 questions and then dividing by 7. | at postoperative 2 months |
| Brief Pain Inventory-short form (BPI-sf) | Brief Pain Inventory-short form (BPI-sf) is composed of two domains measured by the "pain severity" and the "pain interference", Pain severity compartment is composed of 4 items, and pain interference compartment is composed of 7 items (of 24-hour recall period). Each item has 0-10 scales. Brief pain severity score is calculated by adding the scores of 4 questions and then dividing by 4. Brief pain interference score is calculated by adding the scores for 7 questions and then dividing by 7. | at postoperative 4 months |
| Brief Pain Inventory-short form (BPI-sf) | Brief Pain Inventory-short form (BPI-sf) is composed of two domains measured by the "pain severity" and the "pain interference", Pain severity compartment is composed of 4 items, and pain interference compartment is composed of 7 items (of 24-hour recall period). Each item has 0-10 scales. Brief pain severity score is calculated by adding the scores of 4 questions and then dividing by 4. Brief pain interference score is calculated by adding the scores for 7 questions and then dividing by 7. | at postoperative 6 months |
| Patient Global Assessment (PGA) | Patient Global Assessment (PGA) is composed of a single questionnaire assessing the subjective patients-reported outcome. The question is "How is your bladder condition today?". The patients choose one of the following five answers; very-good, god, moderate, bad, very bad. | at postoperative 1 month |
| Patient Global Assessment (PGA) | Patient Global Assessment (PGA) is composed of a single questionnaire assessing the subjective patients-reported outcome. The question is "How is your bladder condition today?". The patients choose one of the following five answers; very-good, god, moderate, bad, very bad. | at postoperative 2 months |
| Patient Global Assessment (PGA) | Patient Global Assessment (PGA) is composed of a single questionnaire assessing the subjective patients-reported outcome. The question is "How is your bladder condition today?". The patients choose one of the following five answers; very-good, god, moderate, bad, very bad. | at postoperative 4 months |
| Patient Global Assessment (PGA) | Patient Global Assessment (PGA) is composed of a single questionnaire assessing the subjective patients-reported outcome. The question is "How is your bladder condition today?". The patients choose one of the following five answers; very-good, god, moderate, bad, very bad. | at postoperative 6 months |
| frequency volume chart parameters | frequency volume chart is a tool for assessment of micturition time, volume of urination and urgency episode. 24-hr frequency of micturition, maximum voided volume, episode of urgency, and nocturia is evaluated. | at postoperative 1 month |
| frequency volume chart parameters | frequency volume chart is a tool for assessment of micturition time, volume of urination and urgency episode. 24-hr frequency of micturition, maximum voided volume, episode of urgency, and nocturia is evaluated. | at postoperative 2 months |
| frequency volume chart parameters | frequency volume chart is a tool for assessment of micturition time, volume of urination and urgency episode. 24-hr frequency of micturition, maximum voided volume, episode of urgency, and nocturia is evaluated. | at postoperative 4 months |
| frequency volume chart parameters | frequency volume chart is a tool for assessment of micturition time, volume of urination and urgency episode. 24-hr frequency of micturition, maximum voided volume, episode of urgency, and nocturia is evaluated. | at postoperative 6 months |
| 30072210 | Background | Bosch PC. A Randomized, Double-blind, Placebo-controlled Trial of Certolizumab Pegol in Women with Refractory Interstitial Cystitis/Bladder Pain Syndrome. Eur Urol. 2018 Nov;74(5):623-630. doi: 10.1016/j.eururo.2018.07.026. Epub 2018 Jul 30. |
| 29315774 | Background | Akiyama Y, Niimi A, Nomiya A, Yamada Y, Nakagawa T, Fujimura T, Fukuhara H, Kume H, Igawa Y, Homma Y. Extent of Hunner lesions: The relationships with symptom severity and clinical parameters in Hunner type interstitial cystitis patients. Neurourol Urodyn. 2018 Apr;37(4):1441-1447. doi: 10.1002/nau.23467. Epub 2018 Jan 9. |
| 35704106 | Derived | Son HS, Yoon H, Lee HS, Kim JH. Prospective randomized controlled trial comparing fulguration versus fulguration and hydrodistension for Hunner-type interstitial cystitis/bladder pain syndrome. World J Urol. 2022 Aug;40(8):2071-2076. doi: 10.1007/s00345-022-04062-8. Epub 2022 Jun 15. |
| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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