SAT vs Escitalopram for Rectal Hypersensitivity
- Conditions
- Rectal HypersensitivityIrritable Bowel Syndrome-Constipation
- Interventions
- Procedure: Sensory Adaptation Training
- Registration Number
- NCT00584571
- Lead Sponsor
- Augusta University
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
All patients must fulfill the diagnostic criteria for IBS-C (Rome III) as defined below and have rectal hypersensitivity (see below).
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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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sensory Adaptation training 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. Escitalopram Therapy 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.
- Primary Outcome Measures
Name Time Method Rectal Sensory Thresholds 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 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.
- Secondary Outcome Measures
Name Time Method Global Bowel Satisfaction Score (GSA) Trial entry and at the end of 3 months The global bowel satisfaction will be analysed using a visual analog scale 0-10 cm (0 - very dissatisfied, 10 - completely satisfied).
Psychological profiles Trial entry and at the end of 3 months The psychological profiles will be assessed using the SCL-90R questionnaire and compared between the two groups.
Rectal compliance Trial entry and at the end of 3 months We will assess the changes in intrarectal pressures and intrarectal volumes during Barostat rectal balloon distention between the two groups.
IBS quality of life Trial entry and at the end of 3 months The IBS quality of life will be assessed using the 8 domains of IBS-QOL and compared between the two groups.
Bowel symptoms Trial entry and at the end of 3 months We will assess the number of complete spontaneous bowel movements, mean straining scores, mean stool consistency (Bristol Stool Scale) (numerical mean scores for individual questions) between the two groups.
Trial Locations
- Locations (2)
Augusta University
🇺🇸Augusta, Georgia, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States