- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03987594
Comparing the Effect of Fulguration Versus Fulguration and Hydrodistension in Interstitial Cystitis/Bladder Pain Syndrome
Prospective Randomized Controlled Trial Comparing the Effect of Fulguration Versus Fulguration and Hydrodistension in Interstitial Cystitis/Bladder Pain Syndrome
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of
- Department of Urology and Urological Science Institute, Yonsei University College of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: TUF
Subjects allocated into TUF+HD group receive bladder hydrodistension prior to transurethral fulguration of 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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
at postoperative one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
at postoperative 6 months
|
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
|
at postoperative 1 month
|
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
|
at postoperative 2 months
|
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
|
at postoperative 4 months
|
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
|
at postoperative 6 months
|
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.
|
at postoperative 1 month
|
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.
|
at postoperative 2 months
|
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.
|
at postoperative 4 months
|
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.
|
at postoperative 6 months
|
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.
|
at postoperative 1 month
|
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.
|
at postoperative 2 months
|
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.
|
at postoperative 4 months
|
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.
|
at postoperative 6 months
|
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.
|
at postoperative 1 month
|
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.
|
at postoperative 2 months
|
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.
|
at postoperative 4 months
|
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.
|
at postoperative 6 months
|
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.
|
at postoperative 1 month
|
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.
|
at postoperative 2 months
|
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.
|
at postoperative 4 months
|
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.
|
at postoperative 6 months
|
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.
|
at postoperative 1 month
|
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.
|
at postoperative 2 months
|
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.
|
at postoperative 4 months
|
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.
|
at postoperative 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2015-0492
- 2016-12-007-001 (Other Identifier: Ewha Womans University Mokdong Hospital)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Interstitial Cystitis
-
Asan Medical CenterCompletedChronic Interstitial CystitisKorea, Republic of
-
St. Louis UniversityTerminated
-
St. Louis UniversityCompletedInterstitial Cystitis
-
Northwell HealthWithdrawnInterstitial CystitisUnited States
-
CAMC Health SystemCompletedInterstitial CystitisUnited States
-
UroGen Pharma Ltd.CompletedInterstitial Cystitis | ICIsrael
-
St. Louis UniversityCompleted
-
Drexel University College of MedicineMedtronicCompleted
-
AllerganTARIS Biomedical, Inc.TerminatedInterstitial CystitisUnited States, Canada
Clinical Trials on Transurethral fulguration of the Hunner lesion
-
Lawson Health Research InstituteGyrus ACMI, Inc.CompletedBenign Prostatic Hyperplasia | BPHCanada
-
Assiut UniversityNot yet recruiting
-
Mansoura UniversityCompletedSexual Functions and Problems in the AdultEgypt
-
Medical University of WarsawCompleted
-
Boston Scientific CorporationCompletedBenign Prostatic HyperplasiaUnited Kingdom, Germany, Austria, Spain, Belgium, France, Italy, Netherlands, Switzerland
-
University Hospital Virgen de las NievesInstituto de Investigación Biosanitaria de Granada (ibs.Granada)RecruitingFibrosis | Hormone Deficiency | Urethral Stricture, MaleSpain
-
Fundacion Miguel ServetCompletedLower Urinary Tract Symptoms | Benign Prostatic Hyperplasia | Transurethral Resection of Prostate | Artery EmbolizationSpain
-
Universidade Cidade de Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloCompletedCervical Intraepithelial NeoplasiaBrazil
-
NeoTract, Inc.CompletedBenign Prostatic HyperplasiaDenmark, United Kingdom, Germany