Pilot Study of NASHA/Dx Gel for Fecal Incontinence

A Pilot Study of Intersphincteric Injection of NASHA/Dx Gel for Fecal Incontinence

The study is an open, prospective, single-site study where 16 patients suffering from fecal incontinence will be included. Change in fecal incontinence episodes after intersphincteric injection of NASHA/Dx gel 4x2 ml and retreatment 4x2 ml after 4 weeks will be measured.

Inclusion Criteria:

1. Fecal incontinence with at least 2 episodes/week
2. Symptom duration at least one year
3. Failed attempt of conservative therapy
4. Age 18-80
5. Written informed consent
6. Available for follow-up
7. Fully compliant with protocol

Exclusion Criteria:

1. Active inflammatory bowel disease
2. Total external sphincter defect at ultrasound and clinical examination
3. Bleeding diathesis or anticoagulant therapy
4. Rectal prolapse or intussusceptions
5. Present anal sepsis
6. Anorectal implants
7. Recent anorectal surgery (within 6 months)
8. Rectal anastomosis
9. Pregnancy, postpartum (one year) or breast feeding