Polyacrylamide Hydrogel Injection Treatment for Anal Incontinence

Last updated: January 9, 2016
Sponsor: Karolinska Institutet
Overall Status: Completed

Phase

4

Condition

Fecal Incontinence

Bowel Dysfunction

Rectal Disorders

Treatment

N/A

Clinical Study ID

NCT02550899
KIDS
  • Ages > 18
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • informed consent, anal incontinence with Wexner score >10

Exclusion

Exclusion Criteria:

  • ino additional pregnancies, schedule for pelvic organ surgery within 1 year oftreatment, current or previous pelvic organ cancer, insulin treated diabetes,inflammatory bowel disease

Study Design

Total Participants: 30
Study Start date:
January 01, 2013
Estimated Completion Date:
February 28, 2014

Study 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.