Prospective Randomized Controlled Trial Comparing the Effect of Fulguration Versus Fulguration and Hydrodistension in Interstitial Cystitis/Bladder Pain Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- inter-group difference of VAS pain score at postoperative one month
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 29 Years 至 83 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cystoscopically proven Hunner lesion, without other demonstrable lower urinary tract diseases
- •Adult patient aged more than 19 years
- •Duration of IC/BPS symptom of more than 6 months
- •VAS pain score more than point 4 (including point 4)
- •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
- •The total score of Pelvic pain urgency/frequency patient symptom scale more than point 13
排除标准
- •Patient with history of bladder hydrodistension or transurethral fulguration within the period of 3 months
- •Women patients who are likely to become pregnant
- •Patients with average voided volume more than 400ml
- •Patients with hematuria suspicious of malignancy
- •Patients with microbiologically proven urinary tract infection during the screening period
- •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
- •Patients with previous history of genitourinary tuberculosis
- •Patients with previous history of genitourinary malignancy
- •Patients with previous history of bladder augmentation
- •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.
- •Patients with neurological diseases which might affect bladder function
- •patients who rely on assisted emptying ; like clean intermittent catheterization or indwelling catheterization
- •patients who are planning to rehabilitation treatment affect the bladder function, like intravesical electronic stimulation
- •patient with alcohol or drug addiction
- •any patient who are not fit for the study based on the investigator's decision
研究组 & 干预措施
TUF
Subjects allocated into TUF+HD group receive bladder hydrodistension prior to transurethral fulguration of Hunner lesion
干预措施: Transurethral fulguration of the Hunner lesion (Procedure)
TUF+HD
Subjects allocated into TUF+HD group receive bladder hydrodistension prior to transurethral fulguration of Hunner lesion
干预措施: Combination treatment of bladder hydrodistension and transurethral fulguration of the Hunner lesion (Procedure)
结局指标
主要结局
inter-group difference of VAS pain score at postoperative one month
时间窗: 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.
次要结局
- inter-group differences in PUF(Pelvic pain and Urgency/Frequency patient symptom scale)(at postoperative 6 months)
- inter-group differences in EQ-5D Health Questionnaire(at postoperative 6 months)
- inter-group differences in drop-out rate at postoperative 6 months(at postoperative 6 months)
- inter-group differences in O'Leary-Sant Interstitial Cystitis-Questionnaires(at postoperative 6 months)
- Patient Global Assessment (PGA)(at postoperative 6 months)
- Brief Pain Inventory-short form (BPI-sf)(at postoperative 6 months)
- frequency volume chart parameters(at postoperative 6 months)