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Comparing the Effect of Fulguration Versus Fulguration and Hydrodistension in Interstitial Cystitis/Bladder Pain Syndrome

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ClinicalTrials.gov Identifier: NCT03987594
Recruitment Status : Completed
First Posted : June 17, 2019
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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).

Condition or disease Intervention/treatment Phase
Interstitial Cystitis Bladder Pain Syndrome Procedure: Transurethral fulguration of the Hunner lesion Procedure: Combination treatment of bladder hydrodistension and transurethral fulguration of the Hunner lesion Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 allocation with Permuted block randomization
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Controlled Trial Comparing the Effect of Fulguration Versus Fulguration and Hydrodistension in Interstitial Cystitis/Bladder Pain Syndrome
Actual Study Start Date : August 1, 2015
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: TUF
Subjects allocated into TUF+HD group receive bladder hydrodistension prior to transurethral fulguration of Hunner lesion
Procedure: Transurethral fulguration of the Hunner lesion
Hunner lesion of the bladder is fulgurated with electronic surgical device under cystoscopic inspection. For the intervention, general or spinal anesthesia is required.

Experimental: TUF+HD
Subjects allocated into TUF+HD group receive bladder hydrodistension prior to transurethral fulguration of Hunner lesion
Procedure: Combination treatment of bladder hydrodistension and transurethral fulguration of the Hunner lesion
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 Measures :
  1. inter-group difference of VAS pain score at postoperative one month [ Time Frame: 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 :
  1. inter-group differences in drop-out rate at postoperative 6 months [ Time Frame: 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)

  2. inter-group differences in O'Leary-Sant Interstitial Cystitis-Questionnaires [ Time Frame: at postoperative 1 month ]
    O'Leary-Sant questionnaire assesses severity of symptoms on the bladder pain, frequency, urgency, nocturia, composed of symptom index and problem index

  3. inter-group differences in O'Leary-Sant Interstitial Cystitis-Questionnaires [ Time Frame: at postoperative 2 months ]
    O'Leary-Sant questionnaire assesses severity of symptoms on the bladder pain, frequency, urgency, nocturia, composed of symptom index and problem index

  4. inter-group differences in O'Leary-Sant Interstitial Cystitis-Questionnaires [ Time Frame: at postoperative 4 months ]
    O'Leary-Sant questionnaire assesses severity of symptoms on the bladder pain, frequency, urgency, nocturia, composed of symptom index and problem index

  5. inter-group differences in O'Leary-Sant Interstitial Cystitis-Questionnaires [ Time Frame: at postoperative 6 months ]
    O'Leary-Sant questionnaire assesses severity of symptoms on the bladder pain, frequency, urgency, nocturia, composed of symptom index and problem index

  6. inter-group differences in PUF(Pelvic pain and Urgency/Frequency patient symptom scale) [ Time Frame: at postoperative 1 month ]
    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.

  7. inter-group differences in PUF(Pelvic pain and Urgency/Frequency patient symptom scale) [ Time Frame: at postoperative 2 months ]
    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.

  8. inter-group differences in PUF(Pelvic pain and Urgency/Frequency patient symptom scale) [ Time Frame: at postoperative 4 months ]
    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.

  9. inter-group differences in PUF(Pelvic pain and Urgency/Frequency patient symptom scale) [ Time Frame: at postoperative 6 months ]
    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.

  10. inter-group differences in EQ-5D Health Questionnaire [ Time Frame: at postoperative 1 month ]
    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.

  11. inter-group differences in EQ-5D Health Questionnaire [ Time Frame: at postoperative 2 months ]
    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.

  12. inter-group differences in EQ-5D Health Questionnaire [ Time Frame: at postoperative 4 months ]
    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.

  13. inter-group differences in EQ-5D Health Questionnaire [ Time Frame: at postoperative 6 months ]
    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.

  14. Brief Pain Inventory-short form (BPI-sf) [ Time Frame: at postoperative 1 month ]
    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.

  15. Brief Pain Inventory-short form (BPI-sf) [ Time Frame: at postoperative 2 months ]
    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.

  16. Brief Pain Inventory-short form (BPI-sf) [ Time Frame: at postoperative 4 months ]
    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.

  17. Brief Pain Inventory-short form (BPI-sf) [ Time Frame: at postoperative 6 months ]
    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.

  18. Patient Global Assessment (PGA) [ Time Frame: at postoperative 1 month ]
    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.

  19. Patient Global Assessment (PGA) [ Time Frame: at postoperative 2 months ]
    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.

  20. Patient Global Assessment (PGA) [ Time Frame: at postoperative 4 months ]
    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.

  21. Patient Global Assessment (PGA) [ Time Frame: at postoperative 6 months ]
    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.

  22. frequency volume chart parameters [ Time Frame: at postoperative 1 month ]
    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.

  23. frequency volume chart parameters [ Time Frame: at postoperative 2 months ]
    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.

  24. frequency volume chart parameters [ Time Frame: at postoperative 4 months ]
    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.

  25. frequency volume chart parameters [ Time Frame: at postoperative 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   29 Years to 83 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987594


Locations
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Korea, Republic of
Department of Urology and Urological Science Institute, Yonsei University College of Medicine
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University

Publications:
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03987594     History of Changes
Other Study ID Numbers: 4-2015-0492 / 2016-12-007-001
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Currently, we do not plan to share patient data with third parties.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yonsei University:
Interstitial Cystitis
Painful Bladder Syndrome
Hydrodistension
Transurethral Fulguration

Additional relevant MeSH terms:
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Syndrome
Somatoform Disorders
Cystitis
Cystitis, Interstitial
Disease
Pathologic Processes
Mental Disorders
Urinary Bladder Diseases
Urologic Diseases