CompletedPhase 4

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

7 participantsStarted 2013-09-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in number of incontinence episodes

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

Trial details

NCT IDNCT03746834

SponsorUppsala University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-12-12

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