Randomized Controlled Trial of Treating Rectal Hypersensitivity - Comparing Escitalopram With Sensory Adaptation Training
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Constipation, Irritable Bowel Syndrome (IBS), Neurology |
| Therapuetic Areas: | Gastroenterology, Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/25/2018 |
| Start Date: | December 2007 |
| End Date: | December 2018 |
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.
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.
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
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
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
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