NASHA/Dx as a Perianal Implant for the Treatment of Persistent Fecal Incontience After Anorectal Malformation

Uppsala University7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fecal Incontinence Anorectal Malformation

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in number of incontinence episodes

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.

Time frame: The change in number of incontinence episodes before treatment is compared with data at 18 months after injection.

Secondary Outcomes

Miller´s incontinence score

Change of Miller´s incontinence score

Time frame: 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).

Quality of life, general

Change in quality of Life as observed with SF-36

Time frame: 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.

Adverse events

Control of any adverse events during the course of the study

Time frame: Before treatment compared with data at 18 months after treatment

Quality of life, disease specific

Change in quality of Life as observed with FIQL

Time frame: Before treatment compared with data at 18 months after treatment. Measures 4 subscales, each measuring 1-4. Higher score implies better quality of life.