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

Interstitial Cystitis Clinical Trial

Official title:

Prospective Randomized Controlled Trial Comparing the Effect of Fulguration Versus Fulguration and Hydrodistension in Interstitial Cystitis/Bladder Pain Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03987594
• Other study ID #: 4-2015-0492
• Secondary ID: 2016-12-007-001
• Status: Completed
• Phase: N/A
• Start date: August 1, 2015
• Est. completion date: October 31, 2018

Study information

• Verified date: August 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 29 Years to 83 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Pain Syndrome
• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis
• Somatoform Disorders
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Urology and Urological Science Institute, Yonsei University College of Medicine	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Yonsei University	Ewha Womans University Mokdong Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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 1 month
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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