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Completed

NCT Number: NCT03746834

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

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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Key information

Conditions

Fecal Incontinence Anorectal Malformation Anorectal Malformations Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NASHA/Dx (Solesta®)

Device

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

Primary outcomes

  1. Change in number of incontinence episodes

    Time frame: 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 outcomes

  1. Miller´s incontinence score

    Time frame: 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

  2. Quality of life, general

    Time frame: 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

  3. Adverse events

    Time frame: Before treatment compared with data at 18 months after treatment

    Control of any adverse events during the course of the study

  4. Quality of life, disease specific

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 20, 2018
Registry last updated
Nov 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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