The purpose of this study is to determine whether anorectal application of Nasha Dx is safe and effective for treatment of anal incontinence.
Patients not fully improved after 1:st injection were offered reinjection after 4-6 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Submucous injection of Nasha Dx 5-10 mm above dentate line
Department of Surgery, University Hospital
751 82 Uppsala, Sweden
Treatment response as measured by a 50% reduction in no of incontinence episodes.
Time frame: One year posttreatment
Adverse events
Time frame: One year posttreatment
Global assessment
Graded by the patient as excellent, good, fair or poor
Time frame: One year posttreatment
Change in incontinence episodes
Measured relative baseline based on a 4-week diary
Time frame: One year posttreatment
Quality of life
Measured with a validated bowel function questionnaire
Time frame: One year posttreatment
Adverse events
Time frame: Two years posttreatment
Global assessment
Graded by the patient as excellent, good, fair or poor
Time frame: Two years posttreatment
Change in incontinence episodes
Measured relative baseline based on a 4-week diary
Time frame: Two years posttreatment
Quality of life
Measured with a validated bowel function questionnaire
Time frame: Two years posttreatment
Treatment response as measured by a 50% reduction in no of incontinence episodes.
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Time frame: Two years posttreatment