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

Phase 4

Completed

• Conditions: Anorectal Malformation; Fecal Incontinence
• Interventions: Device: NASHA/Dx (Solesta®)

• Registration Number: NCT03746834
• Lead Sponsor: Uppsala University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-20
• Primary Completion: 2015-12-12
• Study Completion: 2015-12-12
• Study First Submitted: 2018-05-02
• Status Verified: 2018-11
• Study First Submitted QC: 2018-11-15
• Last Update Submitted: 2018-11-15
• Study First Posted: 2018-11-20
• Last Update Posted: 2018-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment arm	NASHA/Dx (Solesta®)	Patients are given NASHA/Dx as a perianal injection

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Miller´s incontinence score	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).	Change of Miller´s incontinence score
Quality of life, general	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.	Change in quality of Life as observed with SF-36
Adverse events	Before treatment compared with data at 18 months after treatment	Control of any adverse events during the course of the study
Quality of life, disease specific	Before treatment compared with data at 18 months after treatment. Measures 4 subscales, each measuring 1-4. Higher score implies better quality of life.	Change in quality of Life as observed with FIQL