Anal Incontinence Clinical Trial
Official title:
Polyacrylamide Hydrogel Injection Treatment for Anal Incontinence
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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