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Completed

NCT Number: NCT01380132

Safety and Efficacy of Anorectal Application of Dx-gel for Treatment of Anal Incontinence

The purpose of this study is to determine whether anorectal application of Nasha Dx is safe and effective for treatment of anal incontinence.

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Key information

Conditions

Fecal Incontinence Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

18 year–80 year

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department of Surgery, University Hospital

751 82 Uppsala, Sweden

About this study

Patients not fully improved after 1:st injection were offered reinjection after 4-6 weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Incontinence to loose or solid stool at least once weekly (Millers incontinence score 6-12).
  • Age 18-80
  • Available for follow-up for the duration of the study
  • Written informed consent.

Exclusion criteria

  • Sphincter defect visible on anal ultrasound.
  • Pregnancy.
  • Rectal prolapse or inflammatory bowel disease.
  • Recent (within 6 months) anal surgery except for haemorrhoids.
  • Anorectal sepsis.
  • Anticoagulant medication or bleeding diathesis.

Treatment and study plan

Anal injection of Nasha Dx

Procedure

Submucous injection of Nasha Dx 5-10 mm above dentate line

Other names: Solesta

Primary outcomes

  1. Treatment response as measured by a 50% reduction in no of incontinence episodes.

    Time frame: One year posttreatment

Secondary outcomes

  1. Adverse events

    Time frame: One year posttreatment

  2. Global assessment

    Time frame: One year posttreatment

    Graded by the patient as excellent, good, fair or poor

  3. Change in incontinence episodes

    Time frame: One year posttreatment

    Measured relative baseline based on a 4-week diary

  4. Quality of life

    Time frame: One year posttreatment

    Measured with a validated bowel function questionnaire

  5. Adverse events

    Time frame: Two years posttreatment

  6. Global assessment

    Time frame: Two years posttreatment

    Graded by the patient as excellent, good, fair or poor

  7. Change in incontinence episodes

    Time frame: Two years posttreatment

    Measured relative baseline based on a 4-week diary

  8. Quality of life

    Time frame: Two years posttreatment

    Measured with a validated bowel function questionnaire

  9. Treatment response as measured by a 50% reduction in no of incontinence episodes.

    Time frame: Two years posttreatment

Sponsors and collaborators

Lead sponsor

Uppsala University Hospital

Other

Collaborators

  • Galderma R&D

Registry information

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Jun 27, 2011
Registry last updated
Jun 28, 2011

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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