Clinical trial NCT00584571: SAT vs Escitalopram for Rectal Hypersensitivity
Official title: Randomized Controlled Trial of Treating Rectal Hypersensitivity - Comparing Escitalopram With Sensory Adaptation Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rectal Hypersensitivity
Irritable Bowel Syndrome-Constipation
Lead sponsor: Augusta University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-01-02
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Rectal Sensory Thresholds
timeFrame: Trial entry and at the end of 3 months
measure: Abdominal Pain
timeFrame: Trial entry and at the end of 3 months
Secondary outcomes:
measure: Global Bowel Satisfaction Score (GSA)
timeFrame: Trial entry and at the end of 3 months
measure: Bowel symptoms
timeFrame: Trial entry and at the end of 3 months
measure: Rectal compliance
timeFrame: Trial entry and at the end of 3 months
measure: IBS quality of life
timeFrame: Trial entry and at the end of 3 months
measure: Psychological profiles
timeFrame: Trial entry and at the end of 3 months
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: Augusta University
name: Satish SC Rao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.