Randomized Controlled Trial of Treating Rectal Hypersensitivity - Comparing Escitalopram With Sensory Adaptation Training
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00584571|
Recruitment Status : Unknown
Verified March 2015 by Satish Rao, Augusta University.
Recruitment status was: Recruiting
First Posted : January 2, 2008
Last Update Posted : March 11, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Rectal Hypersensitivity Irritable Bowel Syndrome-Constipation||Procedure: Sensory Adaptation Training with Barostat Drug: Escitalopram Therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||December 2007|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||January 2016|
|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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00584571
|Contact: Satish SC Rao, MD, PhDemail@example.com|
|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|