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

Uppsala University

Status and phase: Completed; Phase 4

Conditions: Anorectal Malformation; Fecal Incontinence

Treatments: Device: NASHA/Dx (Solesta®)

Study type: Interventional

Funder types: Other

Identifiers

NCT03746834

461:2013/6500

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Treatment arm

Experimental group

Description:

Patients are given NASHA/Dx as a perianal injection

Treatment:

Device: NASHA/Dx (Solesta®)