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

Primary Purpose

Fecal Incontinence, Anorectal Malformation

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
NASHA/Dx (Solesta®)
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fecal Incontinence focused on measuring Fecal incontinence, Anorectal malformation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment arm

    Arm Description

    Patients are given NASHA/Dx as a perianal injection

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Miller´s incontinence score
    Change of Miller´s incontinence score
    Quality of life, general
    Change in quality of Life as observed with SF-36
    Adverse events
    Control of any adverse events during the course of the study
    Quality of life, disease specific
    Change in quality of Life as observed with FIQL

    Full Information

    First Posted
    May 2, 2018
    Last Updated
    November 15, 2018
    Sponsor
    Uppsala University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03746834
    Brief Title
    NASHA/Dx as a Perianal Implant for the Treatment of Persistent Fecal Incontience After Anorectal Malformation
    Official Title
    NASHA/Dx as a Perianal Implant for the Treatment of Persistent Fecal Incontience After Anorectal Malformation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 20, 2013 (Actual)
    Primary Completion Date
    December 12, 2015 (Actual)
    Study Completion Date
    December 12, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Uppsala University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fecal Incontinence, Anorectal Malformation
    Keywords
    Fecal incontinence, Anorectal malformation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Model Description
    Patients are treated with injection of NASHA/Dx and act as their own Controls over time.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    7 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment arm
    Arm Type
    Experimental
    Arm Description
    Patients are given NASHA/Dx as a perianal injection
    Intervention Type
    Device
    Intervention Name(s)
    NASHA/Dx (Solesta®)
    Intervention Description
    Perianal submucosal injection of 3-4 ml of NASHA/Dx
    Primary Outcome Measure Information:
    Title
    Change in number of incontinence episodes
    Description
    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.
    Time Frame
    The change in number of incontinence episodes before treatment is compared with data at 18 months after injection.
    Secondary Outcome Measure Information:
    Title
    Miller´s incontinence score
    Description
    Change of 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).
    Title
    Quality of life, general
    Description
    Change in quality of Life as observed with SF-36
    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.
    Title
    Adverse events
    Description
    Control of any adverse events during the course of the study
    Time Frame
    Before treatment compared with data at 18 months after treatment
    Title
    Quality of life, disease specific
    Description
    Change in quality of Life as observed with FIQL
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The data collected is of very personal type and since the number of subjects is so small there would be a risk of identification if all the data was released.
    Citations:
    PubMed Identifier
    23224913
    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.
    Results Reference
    result
    PubMed Identifier
    19581853
    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.
    Results Reference
    result
    PubMed Identifier
    27894765
    Citation
    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.
    Results Reference
    result

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

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