Inject Solesta: For significant improvements in patients with fecal incontinence (FI) who have failed conservative therapy1
Quick, outpatient procedure in office and requires no anesthesia1
Dramatic reduction in fecal incontinence episodes
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42.7% reduction in the median number of FI episodes in as little as 3 months2
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53.3% reduction in the median number of FI episodes through 36 months1
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~2X increase of incontinence free days1,3
Learn more about Solesta’s efficacy in reducing FI episodes
Durable efficacy up to 36 months1
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30% increase of Responder50rate from month 3 to month 122
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All three studies show durability of the treatment effect to 24 months as evidenced by proportion Responder501
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The pivotal study, the only study followed to 36 months, showed durability of treatment effect to 36 months1
Learn more about Solesta’s durability
Greater control over fecal incontience1
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Superiority was shown for Solesta vs. Sham at 6 months1
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The sham group received 4 needle sticks identical to the Solesta treatment group, but without therapy1
Learn more about greater control with Solesta
Dependable results without surgery1
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Treatment with Solesta was associated with high response rates in all 3 clinical studies at 6, 12 and 24 months1
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Solesta was proven effective for up to 36 months in the pivotal clinical study1
Learn more about Solesta’s dependable results
Measured impact on quality of life1
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3X greater improvement in Fecal Incontinence Quality of Life (FIQOL) Lifestyle score for patients receiving Solesta vs sham1
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>50% improved Embarrassment and Coping/Behavior scores at 12 months1
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The Fecal Incontinence Quality of Life assessment consists of 29 questions in 4 categories—lifestyle, coping/behavior, depression/self-perception, and embarrassment4
Learn more about increased quality of life with Solesta
Solesta has minimal post-procedure impact on patients1
- Patients may resume limited physical activity immediately
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Patients 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
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96% of adverse events were mild to moderate over 18 months
Solesta clinical studies1
Clinical data supporting the safety and effectiveness of Solesta are available from three clinical studies:
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a pivotal, prospective, multicenter, randomized, sham-controlled double-blind study of 206 patients conducted under an Investigational Device Exemption (IDE; Pivotal study),
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a prospective, multicenter, open-label study of 115 patients conducted outside the United States (Open-Label study), and
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a single center study of 34 patients conducted at one site in Sweden (Proof-of-Concept study). The Pivotal study also included a cross-over option for patients initially randomized to Sham. The majority of patients (over 84%) in all three studies were female.
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a post approval study was conducted per FDA post-marketing surveillance requirements to evaluate long-term efficacy of Solesta. This was a single-arm, multi-site study of 283 patients over 36 months. This showed that Solesta provided significant and long lasting improvements to quality of recipients
The open-label and proof-of-concept studies were followed for 24 months and demonstrated similar safety results as the pivotal study. The pivotal study was followed for 36 months.
References
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Solesta [Package Insert]. Santa Barbara, CA: Palette Life Sciences.
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Solesta Post-Market Approval P100014; 2011.
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Graf W, Mellgren A, Matzel KE, et al; for NASHA Dx Study Group. Efficacy of dextranomer in stabilised hyaluronic acid for treatment of faecal incontinence: a randomised, sham-controlled trial. Lancet. 2011;377:997-1003.
- Rockwood TH, Church JM, Fleshman JW, et al. Fecal incontinence quality of life scale—quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000;43:9-17.