SAT vs Escitalopram for Rectal Hypersensitivity

NCT ID: NCT00584571

Last Updated: 2020-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2019-12-31

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

Conditions

Rectal Hypersensitivity; Irritable Bowel Syndrome-Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Sensory Adaptation Training

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Escitalopram Therapy

Intervention Type: DRUG

Escitalopram; 10 mg every day, orally.

Interventions

Sensory Adaptation Training

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: PROCEDURE

Escitalopram Therapy

Escitalopram; 10 mg every day, orally.

Intervention Type: DRUG

Other Intervention Names

Barostat procedure; Lexapro (Escitalopram) therapy

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Augusta University

OTHER

Sponsor Role: lead

Responsible Party

Satish Rao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Satish SC Rao, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Augusta University

Locations

Augusta University

Augusta, Georgia, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34254966 (View on PubMed)

Other Identifiers

2R01DK057100-06A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2R01 KD57100-05A2

Identifier Type: -

Identifier Source: org_study_id