Fecal Incontinence
Conditions
Brief summary
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.
Interventions
DEVICESolesta (Nasha/Dx)
Gel (hyaluronic acid/dextranomer) for intersphincteric injection 4x2 ml and retreatment 4x2 ml after 4 weeks
Sponsors
Uppsala University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in fecal incontinence episodes | Follow up during a four week period and after 6 and 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Side effects related to treatment | 12 months |
Countries
Sweden
Contacts
Primary ContactWilhelm JR Graf, MD PhD
Outcome results
None listed