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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03746834
Recruitment Status : Completed
First Posted : November 20, 2018
Last Update Posted : November 20, 2018
Information provided by (Responsible Party):
Johan Danielson, 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.

Condition or disease Intervention/treatment Phase
Fecal Incontinence Anorectal Malformation Device: NASHA/Dx (Solesta®) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Patients are treated with injection of NASHA/Dx and act as their own Controls over time.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NASHA/Dx as a Perianal Implant for the Treatment of Persistent Fecal Incontience After Anorectal Malformation
Actual Study Start Date : September 20, 2013
Actual Primary Completion Date : December 12, 2015
Actual Study Completion Date : December 12, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: Treatment arm
Patients are given NASHA/Dx as a perianal injection
Device: NASHA/Dx (Solesta®)
Perianal submucosal injection of 3-4 ml of NASHA/Dx

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Publications of Results:
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Responsible Party: Johan Danielson, Principal investigator, Uppsala University Identifier: NCT03746834     History of Changes
Other Study ID Numbers: 461:2013/6500
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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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
Keywords provided by Johan Danielson, Uppsala University:
Fecal incontinence
Anorectal malformation
Additional relevant MeSH terms:
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Fecal Incontinence
Anorectal Malformations
Congenital Abnormalities
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Digestive System Abnormalities