Clinical Features and Histologic Findings in Bladder Pain Syndrome/Interstitial Cystitis (BPS/IS): New Findings on Useful Correlations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 4
- 主要终点
- correlation between denudation of urothelium and diagnosic delay
研究概览
简要总结
Objectives- to find out whether a correlation exists between denudation of urothelium and diagnosic delay in patients with BPS / IC, secondary aim was to search a correlation between impact of symptoms evaluated with ICSI-ICPI and number of comorbid conditions associated with BPS-IC.
Patients and Methods- Fifty-seven consecutive patients underwent cystoscopy under anaesthesia to classify those cases suspected of BPS/IC. As for the evaluation of the ICSI-ICPI scores we considered significant relevant values those ≥ 12. Patients underwent cystoscopy with hydrodistension under general (90%) or locoregional anaesthesia. Bladder biopsies were taken, including detrusor muscle, from those areas with the most apparent bladder wall lesions. All biopsies were then fixed in 4% formalin and sent to the Pathologist for examination.
详细描述
Between 2005 and 2016, in our Department 57 consecutive patients underwent cystoscopy under anaesthesia to classify those cases suspected of BPS/IC. Patients reported long-lasting irritative bladder symptoms, including urgency, daytime frequency of seven or more episodes, nocturia, and pain in the lower abdomen, lower back, vagina or perineum during filling or after micturition. Alternative diagnoses such as urinary tract infection (UTI) were excluded. Confusable diseases were ruled out by thorough history, clinical examination, urine analysis and imaging.
By means of a detailed medical history we considered the time of symptom onset, frequency of micturitions, the presence of associated diseases. All patients were given the same questionnaire (O'Leary-Sant Interstitial Cystitis Symptom and Problem Index) (19), filled at the time of bladder biopsy.
As for the evaluation of the ICSI-ICPI scores we considered significant relevant values those ≥ 12.
All patients underwent cystoscopy with hydrodistension under general (90%) or locoregional anaesthesia. A rigid cystoscope with a Ch. 22 caliber was used, mannitol solution was used as filling fluid, and infusion height was 80 cm above the symphysis pubis. During filling the bladder was continuously inspected. At maximal capacity, distension was maintained until spontaneous filling stopped and maximum capacity was reached. At this point the bladder was drained and bladder walls and mucosa were closely examined . The bladder was then filled again at approximately half capacity, and at least three deep biopsies were taken, including detrusor muscle, from those areas with the most apparent bladder wall lesions.
All biopsies were then fixed in 4% formalin and sent to the Pathologist for examination. It was specifically asked to assess the presence of urothelial denudation, inflammatory infiltrate, counts of mast cells in the submucosa and detrusor, presence of intrafascicular fibrosis and submucosal bleeding. A cut-off of 28 mast cells / mm2 was used for the assessment of detrusor mastocytosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 19 Years 至 67 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients reported long-lasting irritative bladder symptoms, including urgency, daytime frequency of seven or more episodes, nocturia, and pain in the lower abdomen, lower back, vagina or perineum during filling or after micturition.
排除标准
- •Alternative diagnoses such as urinary tract infection (UTI) were excluded. Confusable diseases were ruled out by thorough history, clinical examination, urine analysis and imaging.
结局指标
主要结局
correlation between denudation of urothelium and diagnosic delay
时间窗: 11 years
to find out whether a correlation exists between denudation of urothelium and diagnosic delay in patients with BPS / IC
次要结局
- correlation between impact of symptoms evaluated with ICSI-ICPI and number of comorbid conditions associated with IC(11 years)
研究者
Daniele Porru
Principal Invesigator
Fondazione IRCCS Policlinico San Matteo di Pavia
