Effects of High-Intensity Focused Ultrasound (HIFU) Treatment on Fecal Continence and Anorretal Fisiology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Anal sphicter evaluation
研究概览
简要总结
Investigate the presence of hypotonic anal sphincter after anorectal dilatation and High-Intensity Focused Ultrasound (HiFU) , through the aplication of questionnaires and Anorectal Manometry before and after this treatment.
详细描述
Primary Investigate the presence of hypotonic anal sphincter after anorectal dilatation and HiFU procedure
Secondary
- Detect the presence of fecal incontinence
- Demonstrate the absence of alterations in the fecal pattern
- Detect alterations in rectal filling sensation and e evacuation desire
- Evaluate anal pain
PATIENTS AND METHODS Thirty (30) consecutive patients indicated for treatment of prostate cancer with HIFU (FocalOneR, Edap TMS, France) will be selected. The specific inclusion and exclusion criteria are specified below. All should present the diagnosis of usual acinar adenocarcinoma of prostate Gleason score 6 (3 + 3) or Gleason 7 (3 + 4). No patient may have PSA greater than 10.0. A digital prostate exam should show prostate-restricted disease. The clinical staging should be ≤ cT2a. There will be no age limit for inclusion. Patients may not have anatomical, functional or pathological alterations of the anal canal and rectus or history of anorectal trauma and may not have a diagnosis of psychoneurologic diseases, such as: Depression, Stroke, Schizophrenia, Degenerative Neurological Diseases or others.
All patients will be submitted to the manometry study the week prior to HIFU together with the application of specific questionnaires (Cleveland Clinic Incontinence Score-CCIS, Fecal Incontinence Quality of Life Score-FIQLS, and Rome IV for functional constipation. This examination will be conducted in a friendly environment and by experienced professionals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients of any age with diagnosis of usual acinar adenocarcinoma of the prostate;
- •Patients that treatment with HIFU is an option;
- •And, that they accept to undergo the pre-and post-HIFU anorectal manometry;
- •And, answer the questionnaires applied;
- •And, signature of the informed consent form.
排除标准
- •Patients who have no indication of HIFU treatment;
- •Or, who have already undergone some anorectal surgery;
- •Or, that they present some psychoneurological disease;
- •Or, who have anatomical, functional or pathological alterations of the rectum or anal;
研究组 & 干预措施
Experimental Group
Thirty (30) consecutive patients indicated for treatment of prostate cancer with HIFU (FocalOneR, Edap TMS, France) will be selected to the manometry study before the treatment together with the application of specific questionnaires (Cleveland Clinic Incontinence Score-CCIS, Fecal Incontinence Quality of Life Score-FIQLS, and Rome IV for functional constipation. This evaluaton will be conducted again after the treatment.
干预措施: Anal Manometry (Diagnostic Test)
结局指标
主要结局
Anal sphicter evaluation
时间窗: 2 months
Investigate the presence of hypotonic anal sphincter after anorectal dilatation and HiFU procedure
次要结局
未报告次要终点