NCT03746834

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fecal Incontinence
• Anorectal Malformation

Interventions

Type	Name	Description
DEVICE	NASHA/Dx (Solesta®)	Perianal submucosal injection of 3-4 ml of NASHA/Dx

Timeline

• Start date: 2013-09-20
• Primary completion: 2015-12-12
• Completion: 2015-12-12
• First posted: 2018-11-20
• Last updated: 2018-11-20