ORALIA Trial Randomized Controlled Trial of Medical Treatment Alone vs Medical Treatment Associated With Anoperineal Physiotherapy for Adult Anal Incontinence. Assessment of Incontinence Symptoms and Quality of Life.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 173
- 试验地点
- 2
- 主要终点
- The primary outcome variable is the patient's response to the question "How would you grade your symptom": major aggravation; aggravation, no changes, improvement and major improvement and rating of that change on an ordinal scale of -5 to +5. The p
研究概览
简要总结
The purpose of this study is to evaluate the impact of anoperineal physiotherapy in adjunction to standard medical treatment on symptoms and quality of life of adults with anal incontinence, in comparison with standard treatment alone.
A total of 443 patients will be randomized to 2 groups: standard care (medical treatment) alone or standard care associated with anoperineal physiotherapy. Outcome measures include the patient own view of the effectiveness of the treatment, the continence score, quality of life and psychological status. These outcomes are measured at the end of the 4 months treatment period.
Following this period, the non responders to standard medical treatment will be proposed to undergo a course of anoperineal physiotherapy and the non responders to anoperineal physiotherapy will be treated by transcutaneous electrical nerve stimulation (TENS). The outcomes will be measured at the end of the 4 months new treatment and again after 4 months follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 75
- •Anal incontinence for more than six months.
- •Signed informed consent
- •Jorge and Wexner's anal incontinence score > or egal 5
排除标准
- •Previous course of anoperineal physiotherapy within the past 6 months
- •Anorectal or perineal surgery within the past 6 months.
- •Indication for anoperineal surgery
- •Vaginal delivery within the past 6 months
- •Pregnancy
- •Major neurological disease,
- •Significant cognitive impairment, dementia or institutionalised.
- •Active inflammatory bowel disease.
- •Current treatment by sacral nerve neurostimulation.
- •Cardiac pacemaker
- •Skin damages preventing transcutaneous electrical nerve stimulation (TENS).
研究组 & 干预措施
standard medical treatment
standard medical treatment
干预措施: Standard medical treatment (Behavioral)
standard medical treatment + anoperineal physiotherapy
standard medical treatment + anoperineal physiotherapy
干预措施: standard medical treatment + anoperineal physiotherapy. (Behavioral)
结局指标
主要结局
The primary outcome variable is the patient's response to the question "How would you grade your symptom": major aggravation; aggravation, no changes, improvement and major improvement and rating of that change on an ordinal scale of -5 to +5. The p
时间窗: during the treatment period
次要结局
- Secondary outcomes include patient's symptoms questionnaire, continence score, quality of life questionnaire, stool diary and psychological status. These secondary outcomes are measured at the end of the 4 months treatment period and the end of follow-up(at the end of the 4 months treatment period and the end of follow-up)