NCT00584571

SAT vs Escitalopram for Rectal Hypersensitivity

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Augusta University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	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.
DRUG	Escitalopram Therapy	Escitalopram; 10 mg every day, orally.

Timeline

• Start date: 2007-12-01
• Primary completion: 2015-12-31
• Completion: 2019-12-31
• First posted: 2008-01-02
• Last updated: 2020-08-06

Locations

2 sites across 1 country: United States