NCT02550899

Polyacrylamide Hydrogel Injection Treatment for Anal Incontinence

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Anal Incontinence

Interventions

Type	Name	Description
PROCEDURE	Transanal submucosal injection group 1	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
PROCEDURE	Transanal submucosal injection group 2	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
PROCEDURE	Transanal submucosal injection group 3	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

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2015-09-16
• Last updated: 2016-01-12