Polyacrylamide Hydrogel Injection Treatment for Anal Incontinence

Karolinska Institute

Status and phase: Completed; Phase 4

Conditions: Anal Incontinence

Treatments: Procedure: Transanal submucosal injection group 1; Procedure: Transanal submucosal injection group 3; Procedure: Transanal submucosal injection group 2

Study type: Interventional

Funder types: Other

Identifiers

NCT02550899

KIDS

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Bulkamid injection treatment group 1

Active Comparator group

Description:

Injection at four sites circumferentially above the dentate line at 12, 3, 6 and 9 o'clock using 4 ml polyacrylamide

Treatment:

Procedure: Transanal submucosal injection group 1

Bulkamid injection treatment group 2

Active Comparator group

Description:

injection at three sites circumferentially above the dentate line at 12, 4 and 8 o'clock using 4 ml polyacrylamide

Treatment:

Procedure: Transanal submucosal injection group 2

Bulkamid injection treatment group 3

Active Comparator group

Description:

injection at three sites circumferentially above the dentate line at 12, 4 and 8 o'clock using 6 ml polyacrylamide

Treatment:

Procedure: Transanal submucosal injection group 3