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

Not Applicable

Completed

• Conditions: Interstitial Cystitis; Bladder Pain Syndrome
• Interventions: Procedure: Combination treatment of bladder hydrodistension and transurethral fulguration of the Hunner lesion; Procedure: Transurethral fulguration of the Hunner lesion

• Registration Number: NCT03987594
• Lead Sponsor: 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).

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.

Study Timeline

• Study Start: 2015-08-01
• Primary Completion: 2018-10-31
• Study Completion: 2018-10-31
• Study First Submitted: 2019-06-13
• Study First Submitted QC: 2019-06-13
• Study First Posted: 2019-06-17
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-29
• Last Update Posted: 2019-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TUF+HD	Combination treatment of bladder hydrodistension and transurethral fulguration of the Hunner lesion	Subjects allocated into TUF+HD group receive bladder hydrodistension prior to transurethral fulguration of Hunner lesion
TUF	Transurethral fulguration of the Hunner lesion	Subjects allocated into TUF+HD group receive bladder hydrodistension prior to transurethral fulguration of Hunner lesion

Primary Outcome Measures

Name	Time	Method
inter-group difference of VAS pain score at postoperative one month	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

Name	Time	Method
inter-group differences in drop-out rate at postoperative 6 months	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	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
inter-group differences in EQ-5D Health Questionnaire	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.
Patient Global Assessment (PGA)	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.
Brief Pain Inventory-short form (BPI-sf)	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.
frequency volume chart parameters	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.
inter-group differences in PUF(Pelvic pain and Urgency/Frequency patient symptom scale)	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.

Trial Locations

Locations (1)

Department of Urology and Urological Science Institute, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of