Completed

NCT Number: NCT00584571

SAT vs Escitalopram for Rectal Hypersensitivity

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.

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Key information

Conditions

Rectal Hypersensitivity Irritable Bowel Syndrome-Constipation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Augusta University, Augusta, Georgia, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sensory Adaptation Training

Procedure

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.

Other names: Barostat procedure

Escitalopram Therapy

Drug

Escitalopram; 10 mg every day, orally.

Other names: Lexapro (Escitalopram) therapy

Primary outcomes

Rectal Sensory Thresholds

Time frame: 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

Time frame: 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 outcomes

Global Bowel Satisfaction Score (GSA)

Time frame: 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).
Bowel symptoms

Time frame: 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.
Rectal compliance

Time frame: 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

Time frame: 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.
Psychological profiles

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Randomized Controlled Trial of Treating Rectal Hypersensitivity - Comparing Escitalopram With Sensory Adaptation Training

Important dates

Study start: 2007
Primary completion: 2015
Study completion: 2019
First posted: Jan 2, 2008
Registry last updated: Aug 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.