Randomized Controlled Trial of Treating Rectal Hypersensitivity - Comparing Escitalopram With Sensory Adaptation Training
Recruitment status was: Recruiting
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.
|Rectal Hypersensitivity Irritable Bowel Syndrome-Constipation||Procedure: Sensory Adaptation Training with Barostat Drug: Escitalopram Therapy||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
- Rectal Sensory Thresholds [ Time Frame: Trial entry and at the end of 3 months ]
- Global Symptom Assessment (GSA) of abdominal discomfort/pain [ Time Frame: Trial entry and at the end of 3 months ]
|Study Start Date:||December 2007|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
|Active Comparator: Sensory Adaptation||
Procedure: Sensory Adaptation Training with Barostat
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 Name: Barostat procedure
|Experimental: Escitalopram Therapy||
Drug: Escitalopram Therapy
Escitalopram; 10 mg every day, orally.
Other Name: Lexapro (Escitalopram) therapy
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584571
|Contact: Satish SC Rao, MD, PhDfirstname.lastname@example.org|
|United States, Iowa|
|University of Iowa Hospitals and Clinics||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Satish SC Rao, MD, PhD||University of Iowa|