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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-20

Study Completion Date

2015-12-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Fecal Incontinence Anorectal Malformation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients are treated with injection of NASHA/Dx and act as their own Controls over time.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment arm

Patients are given NASHA/Dx as a perianal injection

Group Type EXPERIMENTAL

NASHA/Dx (Solesta®)

Intervention Type DEVICE

Perianal submucosal injection of 3-4 ml of NASHA/Dx

Interventions

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NASHA/Dx (Solesta®)

Perianal submucosal injection of 3-4 ml of NASHA/Dx

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No