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

Fecal Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03746834
• Other study ID #: 461:2013/6500
• Status: Completed
• Phase: Phase 4
• Start date: September 20, 2013
• Est. completion date: December 12, 2015

Study information

• Verified date: November 2018
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 12, 2015
• Est. primary completion date: December 12, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anorectal Malformation
• Anorectal Malformations
• Congenital Abnormalities
• Fecal Incontinence

Intervention

Device:
• NASHA/Dx (Solesta®)
Perianal submucosal injection of 3-4 ml of NASHA/Dx

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

References & Publications (3)

Danielson J, Karlbom U, Graf W, Wester T. Outcome in adults with anorectal malformations in relation to modern classification - Which patients do we need to follow beyond childhood? J Pediatr Surg. 2017 Mar;52(3):463-468. doi: 10.1016/j.jpedsurg.2016.10.0 — View Citation

Danielson J, Karlbom U, Sonesson AC, Wester T, Graf W. Submucosal injection of stabilized nonanimal hyaluronic acid with dextranomer: a new treatment option for fecal incontinence. Dis Colon Rectum. 2009 Jun;52(6):1101-6. doi: 10.1007/DCR.0b013e31819f5cbf — View Citation

Danielson J, Karlbom U, Wester T, Graf W. Efficacy and quality of life 2 years after treatment for faecal incontinence with injectable bulking agents. Tech Coloproctol. 2013 Aug;17(4):389-95. doi: 10.1007/s10151-012-0949-8. Epub 2012 Dec 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of incontinence episodes	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.	The change in number of incontinence episodes before treatment is compared with data at 18 months after injection.
Secondary	Miller´s incontinence score	Change of 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).
Secondary	Quality of life, general	Change in quality of Life as observed with SF-36	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.
Secondary	Adverse events	Control of any adverse events during the course of the study	Before treatment compared with data at 18 months after treatment
Secondary	Quality of life, disease specific	Change in quality of Life as observed with FIQL	Before treatment compared with data at 18 months after treatment. Measures 4 subscales, each measuring 1-4. Higher score implies better quality of life.