A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence

Study Overview
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Brief Summary
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The purpose of this study is to determine the effectiveness and safety of NASHA/Dx when used as an injectable bulking agent in the treatment of fecal incontinence. The study includes a 6-month blinded sham-controlled phase, followed by an open-label phase.

Detailed Description
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Subjects will be given up to 2 treatments of NASHA/Dx or sham and followed for 6 months from last treatment (ie, one retreatment is permitted at 1 month after the first injection) in the blinded phase of the study. At Month 6, the open phase of the study will begin and subjects on sham will be offered open-label treatment with NASHA/Dx. Subjects who receive NASHA/Dx at the start of the blinded phase will be followed for up to 36 months from last treatment in the blinded phase. Subjects who receive sham at the start of the blinded phase and then receive open-label NASHA/Dx at Month 6 (start of the open phase) will be followed for another 24 months (equivalent to approximately 30 months from randomization) from last treatment in the open phase of the study.

Official Title
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A Randomized, Subject and Evaluator Blinded, Sham Controlled, Multicenter Study to Evaluate Efficacy and Safety of NASHA/Dx for the Treatment of Fecal Incontinence

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Device: NASHA/Dx (Solesta) Gel
* Device: Sham Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-75 years of age, male or female. Screening fecal incontinence severity score (CCFIS). Fecal incontinence episodes over a 14-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 (IBD). Immunodeficiency or receiving immunosuppressive therapy. Malignancies in remission for less than 2 years prior to the study. Bleeding disorders or receiving anticoagulant therapy. Chemotherapy within the last 12 months prior to the study. Prior Pelvic radiotherapy. Women who are pregnant or breast-feeding, or women of childbearing potential not practicing adequate contraception or planning to stop such contraception within the first year of the study. Women within one year post partum. Participation in any other clinical study within 3 month prior to the study. Hypersensitivity to hyaluronic acid containing products. 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: 75 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blinded injection of NASHA/Dx gel at randomization.<br>Blinded injection of NASHA/Dx (Solesta) Gel. For each treatment, a series of 4 equally spaced injections with 1 mL of Solesta into the anal canal. Subjects will be followed for 6 months during the blinded phase. During a subsequent open phase, these subjects will be followed to Month 36 (ie, for an additional 30 months). | Device: NASHA/Dx (Solesta) Gel<br>* Injection of 4 x 1ml of NASHA/Dx Gel at the start of the blinded phase.<br>* Other names: Solesta;|
| Sham Comparator: Blinded sham inject. at randomization<br>Blinded sham injection (needle stick with empty syringes). For each treatment, a series of 4 equally spaced Sham injections (needle sticks) into the anal canal. Subjects will be followed for 6 months during the blinded phase. Sham-treated subjects have the option to receive open-label injection of NASHA/Dx (Solesta) Gel at the 6-month time point following completion of the blinded phase (ie, blinded sham injection at randomization + NASHA/Dx Gel at 6 months). Following injection of NASHA/Dx gel at the start of the open phase, these subjects will be followed to Month 30 (ie, for an additional 24 months). | Device: Sham Injection<br>* Sham injection at the start of the blinded phase.<br>|
| Other: Blinded Sham Inject. at Randomization + NASHA/Dx Gel at 6 mo.<br>Blinded sham injection at randomization. Subjects will be followed for 6 months during the blinded phase. Sham-treated subjects have the option to receive open-label injection of NASHA/Dx (Solesta) Gel at the 6-month time point following completion of the blinded phase (ie, blinded sham injection at randomization + NASHA/Dx Gel at 6 months). Following injection of NASHA/Dx gel at the start of the open phase, these subjects will be followed to Month 30 (ie, for an additional 24 months). | Device: NASHA/Dx (Solesta) Gel<br>* Injection of 4 x 1ml of NASHA/Dx Gel at the start of the blinded phase.<br>* Other names: Solesta;Device: Sham Injection<br>* Sham injection at the start of the blinded phase.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Are Responder50. | Percentage of participants who achieve ≥ 50% reduction in the number of fecal incontinence episodes compared to baseline (Responder50). | 6 months after last blinded treatment | 
| Percentage of Participants Who Are Responder25. | Response to treatment at 12 months was defined as a ≥ 25 % reduction in the number of fecal incontinence episodes compared to baseline (Responder25). | 12 months after last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Fecal Incontinence Episodes | The number of incontinence episodes collected from a participant incontinence diary spanning a period of 14 days prior to each of the study visits. | up to 6 months after last treatment | 
| Number of Incontinence Free Days | The number of days with no fecal incontinence episodes (incontinence free days). | up to 6 months after last treatment | 
| Change From Baseline in Fecal Incontinence Quality of Life Scale (FIQL). | The disease-specific Fecal Incontinence Quality of Life (FIQL) questionnaire is designed to capture the impact of treatment on quality of life for participants suffering from fecal incontinence as it pertains to 4 domains: Lifestyle, Coping/Behavior, Depression/Self perception and Embarrassment. The more the subject is affected by fecal incontinence the lower the value. Hence, a positive change from baseline indicates improvement. Scores range from 1 to 4. | up to 6 months after last treatment | 
| Cleveland Clinic Florida Incontinence Score (CCFIS). | Cleveland Clinic Florida Incontinence Score (CCFIS) score was based on a participant interview using standardized questions regarding incidence and type of incontinence (solid, liquid or gas), pad usage and lifestyle alterations during the past month. The score ranged from 0 (perfect) to 20 (complete incontinence) | up to 6 months after last treatment |