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A randomized study to evaluate the safety and effects of transanal submucosal polyacrylamide hydrogel injection therapy for anal incontinence.
A prospective randomized study to assess the use of Bulkamid for anal incontinence using three different transanal injection techniques .
Patients with anal incontinence severity Wexner score >7. Standardised injection treatment at baseline. Clinical status and subjective symptom evaluation (Wexner score and FIQL) at baseline, 2 months, 6 months and 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bulkamid injection treatment group 1 | Active Comparator | Injection at four sites circumferentially above the dentate line at 12, 3, 6 and 9 o'clock using 4 ml polyacrylamide |
|
| Bulkamid injection treatment group 2 | Active Comparator | injection at three sites circumferentially above the dentate line at 12, 4 and 8 o'clock using 4 ml polyacrylamide |
|
| Bulkamid injection treatment group 3 | Active Comparator | injection at three sites circumferentially above the dentate line at 12, 4 and 8 o'clock using 6 ml polyacrylamide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transanal submucosal injection group 1 | Procedure | Transanal submucosal injection using an anoscope using four sites circumferentially above the dentate line at 12, 3, 6 and 9 o'clock using 4 ml polyacrylamide |
| Measure | Description | Time Frame |
|---|---|---|
| Wexner overall score | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| FIQL overall score | 1 year | |
| Adverse events | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Altman, MD, PhD | Karolinska Institutet Danderyd Hospital | Study Director |
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| ID | Term |
|---|---|
| D004688 | Encopresis |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
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| Transanal submucosal injection group 2 | Procedure | Transanal submucosal injection using an anoscope using three sites circumferentially above the dentate line at 12, 4 and 8 o'clock using 4 ml polyacrylamide |
|
| Transanal submucosal injection group 3 | Procedure | Transanal submucosal injection using an anoscope using three sites circumferentially above the dentate line at 12, 4 and 8 o'clock using 6 ml polyacrylamide |
|
| D001519 | Behavior |
| D019960 | Elimination Disorders |
| D001523 | Mental Disorders |