Randomized Controlled Trial of Treating Rectal Hypersensitivity - Comparing Escitalopram With Sensory Adaptation Training
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|ClinicalTrials.gov Identifier: NCT00584571|
Recruitment Status : Active, not recruiting
First Posted : January 2, 2008
Last Update Posted : July 23, 2018
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 Drug: Escitalopram Therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Actual Study Start Date :||December 2007|
|Actual Primary Completion Date :||December 31, 2015|
|Estimated Study Completion Date :||December 2018|
Active Comparator: 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.
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.
Other Name: Barostat procedure
Experimental: 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.
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
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Satish SC Rao, MD, PhD||Augusta University|