Polyacrylamide Hydrogel Injection Treatment for Anal Incontinence

Study Overview
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Brief Summary
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A randomized study to evaluate the safety and effects of transanal submucosal polyacrylamide hydrogel injection therapy for anal incontinence.

Detailed Description
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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.

Official Title
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Polyacrylamide Hydrogel Injection Treatment for Anal Incontinence

Conditions
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Anal Incontinence

Intervention / Treatment
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* Procedure: Transanal submucosal injection group 1
* Procedure: Transanal submucosal injection group 2
* Procedure: Transanal submucosal injection group 3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: informed consent, anal incontinence with Wexner score >10 Exclusion Criteria: ino additional pregnancies, schedule for pelvic organ surgery within 1 year of treatment, current or previous pelvic organ cancer, insulin treated diabetes, inflammatory bowel disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bulkamid injection treatment group 1<br>Injection at four sites circumferentially above the dentate line at 12, 3, 6 and 9 o'clock using 4 ml polyacrylamide | Procedure: Transanal submucosal injection group 1<br>* 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<br>|
| Active Comparator: Bulkamid injection treatment group 2<br>injection at three sites circumferentially above the dentate line at 12, 4 and 8 o'clock using 4 ml polyacrylamide | Procedure: Transanal submucosal injection group 2<br>* 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<br>|
| Active Comparator: Bulkamid injection treatment group 3<br>injection at three sites circumferentially above the dentate line at 12, 4 and 8 o'clock using 6 ml polyacrylamide | Procedure: Transanal submucosal injection group 3<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wexner overall score |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FIQL overall score |  | 1 year | 
| Adverse events |  | 1 year |