Solesta: Dependable results without surgery1
Solesta has been studied and proven effective in 3 separate clinical studies for up to 3 years1
Reduction in Fecal Incontinence (FI) Episodes1
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All 3 studies show similar durability of the treatment up to 24 months – the pivotal clinical study, the only study that followed patients for 36 months, showed durability for the length of the study
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At 36 months, FI episodes remained reduced by 52.2%
More Accident Free Days1
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All 3 studies show an increase in number of FI free days with Solesta
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There was ~2X increase of incontinence free days
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At 6 and 12 months, patients with Solesta had a larger increase of FI free days than the control groups
Improved Quality of Life1,2
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3X greater improvement in Fecal Incontinence Quality of Life (FIQOL) Lifestyle score for patients receiving Solesta vs the control group
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>50% improved Embarrassment and Coping/Behavior scores at 12 months
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Patients with Solesta experienced a greater increase in all four Quality of Life categories (Lifestyle, Coping/Behavior, Depression/Self-Perception and Embarrassment ) than the control groups at 6 months2
Improved Fecal Incontinence Scores1
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Using the Cleveland Clinic Fecal Incontinence Score (CCFIS) - a validated measure of the impact of FI – Solesta showed improvements at 12 months1
Solesta has minimal post-procedure impact on patients1
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You may resume limited physical activity immediately
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You are able to resume a normal lifestyle and engage in all physical activities after 1 week (e.g. jogging, bicycling, horseback riding, sexual intercourse, etc.)
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Solesta is unlikely to impede future procedures
Learn more about Fecal Incontinence.
References
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Solesta [Package Insert]. Santa Barbara, CA: Palette Life Sciences.
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Solesta Post-Market Approval P100014; 2011.