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| Name | Class |
|---|---|
| Manitoba Spinal Cord Injury Research Committee | UNKNOWN |
| Canadian Paraplegic Association | OTHER |
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To compare the Peristeen Anal Irrigation System with conservative bowel management in a prospective study among spinal cord injured patients with lower motor neuron neurogenic bowel dysfunction.
People with spinal cord injury (SCI) often have severe problems with management of bowel function, including incontinence, impaction, lengthy bowel routines and extremely slow transit times.The anal irrigation system is a recently available system to help patients with bowel dysfunction empty their bowels by using pulse water irrigation. The system consists of a rectal balloon catheter, manual pump and water container.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Use of a bowel irrigation system | Other | Open label. No placebo use in this study. All volunteers will trial the bowel irrigation system. Eligible volunteers will be those patients who have failed conventional supportive bowel care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peristeen Bowel Irrigation System | Device | A complete system for bowel Irrigation to manage bowel dysfunction |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline on Cleveland Clinic Constipation Scoring System after 10 weeks of treatment | A scoring system with a range of 0-30, with 30 representing the most severe symptoms. Will be used for volunteers whose primary complaint at baseline is constipation. | At baseline Visit and again after 10 weeks of treatment |
| Change from baseline on the St. Mark's Fecal Incontinence Grading System after 10 weeks of treatment. | A Grading system with a range of 0-24, with 24 representing the most severe symptoms. This will be used for volunteers whose primary complaint at baseline is fecal incontinence. | At baseline and again after 10 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in The Neurogenic Bowel Dysfunction Score after 10 weeks of treatment | A symptom score ranging from 0-47, where each symptom of neurogenic bowel is weighted concerning it's impact on quality of life. A score of 47 represents severe symptoms. | At baseline and again after 10 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Ethans, MD | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WRHA Health Sciences Centre Rehabilitation Hospital | Winnipeg | Manitoba | R3A 1M4 | Canada |
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| ID | Term |
|---|---|
| D000077684 | Cauda Equina Syndrome |
| ID | Term |
|---|---|
| D009408 | Nerve Compression Syndromes |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| Change from baseline in a modified American Society of Colon and Rectal Surgeons fecal incontinence score after 10 weeks of treatment. |
Symptom-related Quality of Life Score |
| At baseline and again after 10 weeks of treatment |
| Change from baseline measurement of Colonic Transit Time (CTT)after 10 weeks of treatment | The Metcalf method will be used.At the screening visit,eligible volunteers will be given a 7-day bowel diary and 3 SitzMark capsules with instructions on how to complete the diary and when to take the capsules. Abdominal X-rays will be obtained on Day 4 and 7. The patient will repeat the diary, SitzMark capsules and X-rays during the last week of study treatment. | At baseline and again after 10 weeks of treatment. |
| Change from baseline on a numeric box scale to measure bowel function, influence on daily activities, and general satisfaction after 10 weeks of treatment. | Numeric box scales with a range of 1-10 | At baseline and after 10 weeks of treatment. |
| Measurement of Influence of Current Bowel Management on Quality of Life | A numeric box scale with a range of 0-10, with 0 representing great reduction and 10 representing great improvement. | After 10 weeks of treatment |
| D011129 | Polyradiculoneuropathy |
| D011115 | Polyneuropathies |