Back to resultsSAT vs Escitalopram for Rectal Hypersensitivity
Primary Purpose
Rectal Hypersensitivity, Irritable Bowel Syndrome-Constipation
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sensory Adaptation Training
Escitalopram Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Hypersensitivity
Eligibility Criteria
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.
Sites / Locations
- Augusta University
- University of Iowa Hospitals and Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Sensory Adaptation training
Escitalopram Therapy
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Rectal Sensory Thresholds
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
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
Global Bowel Satisfaction Score (GSA)
The global bowel satisfaction will be analysed using a visual analog scale 0-10 cm (0 - very dissatisfied, 10 - completely satisfied).
Bowel symptoms
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.
Rectal compliance
We will assess the changes in intrarectal pressures and intrarectal volumes during Barostat rectal balloon distention between the two groups.
IBS quality of life
The IBS quality of life will be assessed using the 8 domains of IBS-QOL and compared between the two groups.
Psychological profiles
The psychological profiles will be assessed using the SCL-90R questionnaire and compared between the two groups.
Full Information
NCT ID
NCT00584571
First Posted
December 21, 2007
Last Updated
August 4, 2020
Sponsor
Augusta University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00584571
Brief Title
SAT vs Escitalopram for Rectal Hypersensitivity
Official Title
Randomized Controlled Trial of Treating Rectal Hypersensitivity - Comparing Escitalopram With Sensory Adaptation Training
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 2007 (Actual)
Primary Completion Date
December 31, 2015 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Augusta University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Hypersensitivity, Irritable Bowel Syndrome-Constipation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sensory Adaptation training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Escitalopram Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sensory Adaptation Training
Other Intervention Name(s)
Barostat procedure
Intervention Description
This study will last for approximately 3 months and will include 4-6 clinic visits with each visit lasting 2 hours every week or every 2 weeks. At the beginning of each visit we will ask you about your health status and level of satisfaction of your bowel habits. We will then place the pencil-thick probe and balloon inside your rectum and attach it to the barostat device and a computer. We will increase and decrease the volumes of the balloon until the most pressure you can tolerate or a certain level of pressure as measured by the machine is reached, whichever occurs first. You will continue to keep stool diaries and pain diaries for 7 days before and after each visit.
Intervention Type
Drug
Intervention Name(s)
Escitalopram Therapy
Other Intervention Name(s)
Lexapro (Escitalopram) therapy
Intervention Description
Escitalopram; 10 mg every day, orally.
Primary Outcome Measure Information:
Title
Rectal Sensory Thresholds
Description
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.
Time Frame
Trial entry and at the end of 3 months
Title
Abdominal Pain
Description
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.
Time Frame
Trial entry and at the end of 3 months
Secondary Outcome Measure Information:
Title
Global Bowel Satisfaction Score (GSA)
Description
The global bowel satisfaction will be analysed using a visual analog scale 0-10 cm (0 - very dissatisfied, 10 - completely satisfied).
Time Frame
Trial entry and at the end of 3 months
Title
Bowel symptoms
Description
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.
Time Frame
Trial entry and at the end of 3 months
Title
Rectal compliance
Description
We will assess the changes in intrarectal pressures and intrarectal volumes during Barostat rectal balloon distention between the two groups.
Time Frame
Trial entry and at the end of 3 months
Title
IBS quality of life
Description
The IBS quality of life will be assessed using the 8 domains of IBS-QOL and compared between the two groups.
Time Frame
Trial entry and at the end of 3 months
Title
Psychological profiles
Description
The psychological profiles will be assessed using the SCL-90R questionnaire and compared between the two groups.
Time Frame
Trial entry and at the end of 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Satish SC Rao, MD, PhD
Organizational Affiliation
Augusta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34254966
Citation
Rao SSC, Coss-Adame E, Yan Y, Erdogan A, Valestin J, Ayyala DN. Sensory Adaptation Training or Escitalopram for IBS With Constipation and Rectal Hypersensitivity: A Randomized Controlled Trial. Clin Transl Gastroenterol. 2021 Jul 13;12(7):e00381. doi: 10.14309/ctg.0000000000000381.
Results Reference
derived
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SAT vs Escitalopram for Rectal Hypersensitivity
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