Randomized Controlled Trial of Treating Rectal Hypersensitivity - Comparing Escitalopram With Sensory Adaptation Training
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Rectal Sensory Thresholds
研究概览
简要总结
Constipation is a common digestive disorder. After excluding dietary factors, drugs and other secondary causes, at least three broad pathophysiologic subtypes are recognized- dyssynergic defecation, constipation-predominant irritable bowel syndrome (IBS-C) and slow transit constipation (STC), all predominantly affect women and elderly. Many patients also demonstrate abnormal rectal perception with both rectal hyposensitivity and hypersensitivity being common. Recent surveys show that most constipated patients are dissatisfied with current therapy. Also, constipated patients showed significant psychological dysfunction and impaired quality of life. OBJECTIVE: To investigate a novel biofeedback technique of improving rectal hypersensitivity.
METHODS: A large compliant balloon attached to a barostat was placed in the rectum in 8 patients with rectal hypersensitivity (urgency/pain threshold <30 mm Hg). Sensory deconditioning was performed by incremental balloon distensions (1-2 mmHg) until normal thresholds were reached.
详细描述
To investigate a novel biofeedback technique of improving rectal hypersensitivity using rectal barostat and to compare this with clinical standard of care comprising of low dose antidepressant therapy with escitalopram. Patients will be randomized to sensory adaptation training or escitalopram in a 1:1 ratio
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients must fulfill the diagnostic criteria for IBS-C (Rome III) as defined below and have rectal hypersensitivity (see below).
- •Patients must report recurrent abdominal pain or discomfort for at least 3 days per month in the last 3 months with two or more of the following symptoms:
- •Improvement with defecation; and/or
- •Onset associated with a change in frequency of stool; and/or
- •Onset associated with a change in form (appearance) of stool
- •No structural diseases
- •On a diary:
- •Pain/discomfort for at least 2 days/week;
- •No loose or watery stool <25% of bowel movements.
排除标准
- •Patients with mixed-IBS.
- •Patients currently on SSRI or MAO inhibitors. Patients on stable doses of other antidepressants will be included provided the dose is unchanged during study.
- •Patients taking drugs that are constipating, (e.g.; calcium channel antagonists will either be excluded or drug discontinued)
- •Patients with co-morbid illnesses; severe cardiac disease, chronic renal failure or previous gastrointestinal surgery except cholecystectomy and appendectomy.
- •Neurologic diseases e.g.; head injury, epilepsy, multiple sclerosis, strokes, spinal cord injuries.
- •Impaired cognizance (mini mental score of < 15) and/or legally blind.
- •Pregnant or likely to conceive during the course of the study. Women with potential for pregnancy must be willing to use contraceptive measures during the study. Urinary pregnancy tests will be performed on such women prior to any radiologic procedures.
- •Hirschsprung's disease.
- •Alternating constipation and diarrhea (22).
- •Ulcerative/Crohns colitis.
- •Previous pelvic surgery, rectocele/bladder repair, radical hysterectomy, anal surgery.
- •Rectal prolapse or anal fissure.
研究组 & 干预措施
Sensory Adaptation training
a large compliant balloon is placed in the rectum attached to a barostat. The balloon is distended in 1 mm increments until patient reports moderate discomfort and then increased in 1 mm increments until maximum tolerable pressure. Gradually over 6 training sessions, administered biweekly, the maximum tolerable pressure is increased over 3 months, if treatment is successful.
干预措施: Sensory Adaptation Training (Procedure)
Escitalopram Therapy
Patients randomized to this arm will receive daily 10 mg escitalopram for 3 months. If the medication is effective their bowel symptoms and pain thersholds will improve.
干预措施: Escitalopram Therapy (Drug)
结局指标
主要结局
Rectal Sensory Thresholds
时间窗: Trial entry and at the end of 3 months
The primary physiologic outcome measure is increase in rectal sensory thresholds after treatment. A rectal hypersensitivity responder is defined as an individual who show at least 20% increase in two or more sensory thresholds (first, desire and urge defecate/pain) after treatment when compared to baseline, and will be compared between the SAT and escitalopram groups. An overall responder is defined as both a hypersensitivity responder and abdominal pain responder.
Abdominal Pain
时间窗: Trial entry and at the end of 3 months
The symptomatic outcome measure is decrease in pain score as assessed by daily pain logs where pain is scored on a scale of 0 to 4, after treatment when compared to the baseline period. A pain responder is defined as a subject with 30% decrease in pain compared to baseline.
次要结局
- Global Bowel Satisfaction Score (GSA)(Trial entry and at the end of 3 months)
- Psychological profiles(Trial entry and at the end of 3 months)
- Rectal compliance(Trial entry and at the end of 3 months)
- IBS quality of life(Trial entry and at the end of 3 months)
- Bowel symptoms(Trial entry and at the end of 3 months)