Study to Evaluate Solesta for Treatment of Fecal Incontinence

Study Overview
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Brief Summary
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The study will evaluate the safety and efficacy of Solesta as an injectable bulking agent in the treatment of fecal incontinence for a total of 24 months after completed treatment.

Official Title
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An Open, Non-comparative, Post-marketing, Multi-center Study to Evaluate Efficacy and Safety of SolestaTM for the Treatment of Fecal Incontinence

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Device: Solesta (Dextranomer in gel of stabilized non-animal hyaluronate)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-80 years of age, male or female Screening fecal incontinence severity score (CCFIS) Fecal incontinence episodes over a 28-day period Failed conservative treatment for fecal incontinence Exclusion Criteria: Complete external sphincter disruption Significant anorectal disease Anorectal surgery within the last 12 months prior to the study Active Inflammatory Bowel Disease Immunodeficiency or receiving immunosuppressive therapy Malignancies in remission for less than 1 years prior to the study Bleeding disorders or receiving anticoagulant therapy Chemotherapy within the last 6 months prior to the study Prior Pelvic radiotherapy Pregnant or breast-feeding women, or women of childbearing potential not practicing adequate contraception or planning to stop such contraception within the first year of the study Women within 6 months post partum Participation in any other clinical study within 3 month prior to the study Other severe conditions or in other ways unsuitable to participate according to investigator judgement

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Solesta<br>Open label. Solesta (Dextranomer in gel of stabilized non-animal hyaluronate) The study treatment consisted of 4 submucosal injections, 1 mL Solesta each, in the proximal part of the high pressure zone in the anal canal. Re-treatment is allowed one month after initial treatment if the subject is still incontinent. | Device: Solesta (Dextranomer in gel of stabilized non-animal hyaluronate)<br> <br> * Other names: Solesta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder Rate in Number of Fecal Incontinence Episodes | Responder rate in number of fecal incontinence episodes change from baseline at 12 month. Defined as responders at 12 month after treatment. A responder was defined as 50% or more reduction in the number of fecal incontinence episodes (28-day diary data)of solid or loose stool, compared to baseline. | 12 months after last treatment compared to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Fecal Incontinence Episodes. | Number of fecal incontinence episodes, change from baseline (change in patient diary data at 12 month). | at 12 month - change from baseline | 
| Fecal Incontinence Severity Using the Cleveland Clinic Florida Incontinence Score | Cleveland Clinic Florida Incontinence Score (CCFIS) is a composite score of incontinence severity that measures the frequencies of gas leakage, leakage of solid or loose stool, use of protective pads and lifestyle alterations. The score ranges from 0 (representing complete continence)to 20 (representing complete incontinence). Change from baseline. | 12 month - change from baseline | 
| Fecal Incontinence Quality of Life (FIQL) | Fecal Incontinence Quality of Life is a disease specific questionnaire composed of a total of 29 questions questions divided into four domains: Lifestyle, Coping/Behavior, Depression/Self perception, and Embarrassment. The FIQL mean score ranges from 1 to 4 for the Lifestyle, Coping/Behavior and Embarrassment domains, and from 1 to 4.429 for Depression/Self-Perception domain. Mean score were calculated for each of the four domains. The more the subject is affected by fecal incontinence the lower value. Change from baseline. | At 12 month - change from baseline | 
| Number of Incontinence-free Days | Number of incontinence-free days, change from baseline (change in patient diary data at 12 month). | At 12 month- change from baseline |