Polyacrylamide Hydrogel Injection Treatment for Anal Incontinence

Phase 4

Completed

• Conditions: Anal Incontinence
• Interventions: Procedure: Transanal submucosal injection group 2; Procedure: Transanal submucosal injection group 3; Procedure: Transanal submucosal injection group 1

• Registration Number: NCT02550899
• Lead Sponsor: Karolinska Institutet

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Study First Submitted: 2015-09-12
• Study First Submitted QC: 2015-09-14
• Study First Posted: 2015-09-16
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-09
• Last Update Posted: 2016-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• informed consent, anal incontinence with Wexner score >10

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bulkamid injection treatment group 2	Transanal submucosal injection group 2	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	Transanal submucosal injection group 3	injection at three sites circumferentially above the dentate line at 12, 4 and 8 o'clock using 6 ml polyacrylamide
Bulkamid injection treatment group 1	Transanal submucosal injection group 1	Injection at four sites circumferentially above the dentate line at 12, 3, 6 and 9 o'clock using 4 ml polyacrylamide

Primary Outcome Measures

Name	Time	Method
Wexner overall score	1 year

Secondary Outcome Measures

Name	Time	Method
FIQL overall score	1 year
Adverse events	1 year