Back to resultsComparing the Effect of Fulguration Versus Fulguration and Hydrodistension in Interstitial Cystitis/Bladder Pain Syndrome
Primary Purpose
Interstitial Cystitis, Bladder Pain Syndrome
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Transurethral fulguration of the Hunner lesion
Combination treatment of bladder hydrodistension and transurethral fulguration of the Hunner lesion
Sponsored by
About this trial
This is an interventional treatment trial for Interstitial Cystitis focused on measuring Interstitial Cystitis, Painful Bladder Syndrome, Hydrodistension, Transurethral Fulguration
Eligibility Criteria
Inclusion Criteria:
- 1. cystoscopically proven Hunner lesion, without other demonstrable lower urinary tract diseases
- 2. Adult patient aged more than 19 years
- 3. Duration of IC/BPS symptom of more than 6 months
- 4. VAS pain score more than point 4 (including point 4)
- 5. The total score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) symptom and problem is more than 12 with the score of pain item is more than 2
- 6. The total score of Pelvic pain urgency/frequency patient symptom scale more than point 13
Exclusion Criteria:
- 1. Patient with history of bladder hydrodistension or transurethral fulguration within the period of 3 months
- 2. Women patients who are likely to become pregnant
- 3. Patients with average voided volume more than 400ml
- 4. Patients with hematuria suspicious of malignancy
- 5. Patients with microbiologically proven urinary tract infection during the screening period
- 6. Patients with microbiologically proven recurrent urinary tract infection, more than twice during the last 6 months or more than three times of infection during the last year
- 7. Patients with previous history of genitourinary tuberculosis
- 8. Patients with previous history of genitourinary malignancy
- 9. Patients with previous history of bladder augmentation
- 10. Patient with following surgery within recent 6 months at screening; hysterectomy, midureteral or suburethral sling operation, transvaginal operation, pelvic organ prolapse surgery, vaginal delivery, Caesarean section, prostate surgery, and any other treatment that might affect bladder sensation and bladder function.
- 11. Patients with neurological diseases which might affect bladder function
- 12. patients who rely on assisted emptying ; like clean intermittent catheterization or indwelling catheterization
- 13. patients who are planning to rehabilitation treatment affect the bladder function, like intravesical electronic stimulation
- 14. patient with alcohol or drug addiction
- 15. any patient who are not fit for the study based on the investigator's decision
Sites / Locations
- Department of Urology and Urological Science Institute, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
TUF
TUF+HD
Arm Description
Subjects allocated into TUF+HD group receive bladder hydrodistension prior to transurethral fulguration of Hunner lesion
Subjects allocated into TUF+HD group receive bladder hydrodistension prior to transurethral fulguration of Hunner lesion
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
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
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
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03987594
First Posted
June 13, 2019
Last Updated
August 29, 2019
Sponsor
Yonsei University
Collaborators
Ewha Womans University Mokdong Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03987594
Brief Title
Comparing the Effect of Fulguration Versus Fulguration and Hydrodistension in Interstitial Cystitis/Bladder Pain Syndrome
Official Title
Prospective Randomized Controlled Trial Comparing the Effect of Fulguration Versus Fulguration and Hydrodistension in Interstitial Cystitis/Bladder Pain Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2015 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
Collaborators
Ewha Womans University Mokdong Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis, Bladder Pain Syndrome
Keywords
Interstitial Cystitis, Painful Bladder Syndrome, Hydrodistension, Transurethral Fulguration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 allocation with Permuted block randomization
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TUF
Arm Type
Placebo Comparator
Arm Description
Subjects allocated into TUF+HD group receive bladder hydrodistension prior to transurethral fulguration of Hunner lesion
Arm Title
TUF+HD
Arm Type
Experimental
Arm Description
Subjects allocated into TUF+HD group receive bladder hydrodistension prior to transurethral fulguration of Hunner lesion
Intervention Type
Procedure
Intervention Name(s)
Transurethral fulguration of the Hunner lesion
Intervention Description
Hunner lesion of the bladder is fulgurated with electronic surgical device under cystoscopic inspection. For the intervention, general or spinal anesthesia is required.
Intervention Type
Procedure
Intervention Name(s)
Combination treatment of bladder hydrodistension and transurethral fulguration of the Hunner lesion
Intervention Description
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.
Primary Outcome Measure Information:
Title
inter-group difference of VAS pain score at postoperative one month
Description
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.
Time Frame
at postoperative one month
Secondary Outcome Measure Information:
Title
inter-group differences in drop-out rate at postoperative 6 months
Description
Assessment of Drop-out rate is performed at the point of postoperative 6 months (both using the Intention-To-Treat and Per-Protocol analysis)
Time Frame
at postoperative 6 months
Title
inter-group differences in O'Leary-Sant Interstitial Cystitis-Questionnaires
Description
O'Leary-Sant questionnaire assesses severity of symptoms on the bladder pain, frequency, urgency, nocturia, composed of symptom index and problem index
Time Frame
at postoperative 1 month
Title
inter-group differences in O'Leary-Sant Interstitial Cystitis-Questionnaires
Description
O'Leary-Sant questionnaire assesses severity of symptoms on the bladder pain, frequency, urgency, nocturia, composed of symptom index and problem index
Time Frame
at postoperative 2 months
Title
inter-group differences in O'Leary-Sant Interstitial Cystitis-Questionnaires
Description
O'Leary-Sant questionnaire assesses severity of symptoms on the bladder pain, frequency, urgency, nocturia, composed of symptom index and problem index
Time Frame
at postoperative 4 months
Title
inter-group differences in O'Leary-Sant Interstitial Cystitis-Questionnaires
Description
O'Leary-Sant questionnaire assesses severity of symptoms on the bladder pain, frequency, urgency, nocturia, composed of symptom index and problem index
Time Frame
at postoperative 6 months
Title
inter-group differences in PUF(Pelvic pain and Urgency/Frequency patient symptom scale)
Description
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.
Time Frame
at postoperative 1 month
Title
inter-group differences in PUF(Pelvic pain and Urgency/Frequency patient symptom scale)
Description
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.
Time Frame
at postoperative 2 months
Title
inter-group differences in PUF(Pelvic pain and Urgency/Frequency patient symptom scale)
Description
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.
Time Frame
at postoperative 4 months
Title
inter-group differences in PUF(Pelvic pain and Urgency/Frequency patient symptom scale)
Description
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.
Time Frame
at postoperative 6 months
Title
inter-group differences in EQ-5D Health Questionnaire
Description
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.
Time Frame
at postoperative 1 month
Title
inter-group differences in EQ-5D Health Questionnaire
Description
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.
Time Frame
at postoperative 2 months
Title
inter-group differences in EQ-5D Health Questionnaire
Description
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.
Time Frame
at postoperative 4 months
Title
inter-group differences in EQ-5D Health Questionnaire
Description
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.
Time Frame
at postoperative 6 months
Title
Brief Pain Inventory-short form (BPI-sf)
Description
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.
Time Frame
at postoperative 1 month
Title
Brief Pain Inventory-short form (BPI-sf)
Description
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.
Time Frame
at postoperative 2 months
Title
Brief Pain Inventory-short form (BPI-sf)
Description
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.
Time Frame
at postoperative 4 months
Title
Brief Pain Inventory-short form (BPI-sf)
Description
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.
Time Frame
at postoperative 6 months
Title
Patient Global Assessment (PGA)
Description
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.
Time Frame
at postoperative 1 month
Title
Patient Global Assessment (PGA)
Description
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.
Time Frame
at postoperative 2 months
Title
Patient Global Assessment (PGA)
Description
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.
Time Frame
at postoperative 4 months
Title
Patient Global Assessment (PGA)
Description
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.
Time Frame
at postoperative 6 months
Title
frequency volume chart parameters
Description
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.
Time Frame
at postoperative 1 month
Title
frequency volume chart parameters
Description
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.
Time Frame
at postoperative 2 months
Title
frequency volume chart parameters
Description
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.
Time Frame
at postoperative 4 months
Title
frequency volume chart parameters
Description
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.
Time Frame
at postoperative 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
29 Years
Maximum Age & Unit of Time
83 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. cystoscopically proven Hunner lesion, without other demonstrable lower urinary tract diseases
2. Adult patient aged more than 19 years
3. Duration of IC/BPS symptom of more than 6 months
4. VAS pain score more than point 4 (including point 4)
5. The total score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) symptom and problem is more than 12 with the score of pain item is more than 2
6. The total score of Pelvic pain urgency/frequency patient symptom scale more than point 13
Exclusion Criteria:
1. Patient with history of bladder hydrodistension or transurethral fulguration within the period of 3 months
2. Women patients who are likely to become pregnant
3. Patients with average voided volume more than 400ml
4. Patients with hematuria suspicious of malignancy
5. Patients with microbiologically proven urinary tract infection during the screening period
6. Patients with microbiologically proven recurrent urinary tract infection, more than twice during the last 6 months or more than three times of infection during the last year
7. Patients with previous history of genitourinary tuberculosis
8. Patients with previous history of genitourinary malignancy
9. Patients with previous history of bladder augmentation
10. Patient with following surgery within recent 6 months at screening; hysterectomy, midureteral or suburethral sling operation, transvaginal operation, pelvic organ prolapse surgery, vaginal delivery, Caesarean section, prostate surgery, and any other treatment that might affect bladder sensation and bladder function.
11. Patients with neurological diseases which might affect bladder function
12. patients who rely on assisted emptying ; like clean intermittent catheterization or indwelling catheterization
13. patients who are planning to rehabilitation treatment affect the bladder function, like intravesical electronic stimulation
14. patient with alcohol or drug addiction
15. any patient who are not fit for the study based on the investigator's decision
Facility Information:
Facility Name
Department of Urology and Urological Science Institute, Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Currently, we do not plan to share patient data with third parties.
Citations:
PubMed Identifier
29777618
Citation
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.
Results Reference
background
PubMed Identifier
29566264
Citation
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.
Results Reference
background
PubMed Identifier
30072210
Citation
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.
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PubMed Identifier
29315774
Citation
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.
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PubMed Identifier
35704106
Citation
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.
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Comparing the Effect of Fulguration Versus Fulguration and Hydrodistension in Interstitial Cystitis/Bladder Pain Syndrome
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