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

NCT03746834 | Completed Phase 4

• 1 other identifier: 461:2013/6500
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fecal Incontinence; Anorectal Malformation

Keywords

Fecal incontinence; Anorectal malformation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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).

• 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.

• Adverse events

  Before treatment compared with data at 18 months after treatment

• 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.

Study Arms (1)

Treatment arm

EXPERIMENTAL

Patients are given NASHA/Dx as a perianal injection

Device: NASHA/Dx (Solesta®)

Interventions

NASHA/Dx (Solesta®) DEVICE

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

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persistent FI (Miller incontinence score \>5)
• Anorectal malformation.

You may not qualify if:

• Pregnancy
• Rectal prolapse
• Significant mucosal prolapse
• Inflammatory bowel disease
• Anticoagulant medication/bleeding diathesis
• Anorectal sepsis in the past
• Immunodeficiency
• Immunosuppressing therapy

Sponsors & Collaborators

• Uppsala University: lead

Related Publications (3)

• 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.

  PMID: 23224913 RESULT

• 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.

  PMID: 19581853 RESULT

• 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.2016.10.051. Epub 2016 Nov 15.

  PMID: 27894765 RESULT

MeSH Terms

Conditions

Fecal Incontinence; Anorectal Malformations

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

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

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: November 20, 2018
• Study Start: September 20, 2013
• Primary Completion: December 12, 2015
• Study Completion: December 12, 2015
• Last Updated: November 20, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share