Polyacrylamide Hydrogel Injection Treatment for Anal Incontinence

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02550899
Study type	Interventional
Source	Karolinska Institutet
Contact
Status	Completed
Phase	Phase 4
Start date	January 2013
Completion date	February 2014

View Details

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