Anorectal Malformation, Fecal Incontinence
Conditions
Keywords
Fecal incontinence, Anorectal malformation
Brief summary
Persistent fecal incontinence (FI) after anorectal malformations (ARM) is a common occurence. During the last two decades perianal injection therapy has emerged as an option for treating patients with FI due to other causes than ARMs. The studies done on different implants have always expempted patients with ARM which has led to ARM being a formal contraindication for treatment with perianal injection therapy. The study aims to treat patients with persistent FI after ARM with perianal injection of NASHA/Dx (Solesta®) and follow them with Clinical examination and questionnaires up to 18 months post treatment.
Interventions
DEVICENASHA/Dx (Solesta®)
Perianal submucosal injection of 3-4 ml of NASHA/Dx
Sponsors
Uppsala University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients are treated with injection of NASHA/Dx and act as their own Controls over time.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Persistent FI (Miller incontinence score \>5) * Anorectal malformation.
Exclusion criteria
* Pregnancy * Rectal prolapse * Significant mucosal prolapse * Inflammatory bowel disease * Anorectal surgery within the last year Before inclusion * Anticoagulant medication/bleeding diathesis * Anorectal sepsis in the past * Immunodeficiency * Immunosuppressing therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in number of incontinence episodes | The change in number of incontinence episodes before treatment is compared with data at 18 months after injection. | The number of incontinences episodes as measured over a two week interval The number of incontience episodes is measured with a bowel-movement-diary over a two week period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Miller´s incontinence score | Before treatment compared with data at 18 months after treatment. Miller´s incontinence score is measured on a scale from 0 (meaning total fecal continence) to 18 (meaning total fecal incontinence). | Change of Miller´s incontinence score |
| Quality of life, general | Before treatment compared with data at 18 months after treatment. SF-36 measures quality of life in 8 subscales. Each scaled from 0 to 100. Higher score is considered better. Two total scores of mental and physical QoL can be calculated. | Change in quality of Life as observed with SF-36 |
| Adverse events | Before treatment compared with data at 18 months after treatment | Control of any adverse events during the course of the study |
| Quality of life, disease specific | Before treatment compared with data at 18 months after treatment. Measures 4 subscales, each measuring 1-4. Higher score implies better quality of life. | Change in quality of Life as observed with FIQL |
Outcome results
None listed