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

• 42.7% reduction in the median number of FI episodes in as little as 3 months²

• 53.3% reduction in the median number of FI episodes through 36 months¹

• ~2X increase of incontinence free days^1,3

Learn more about Solesta’s efficacy in reducing FI episodes

Durable efficacy up to 36 months¹

• 30% increase of Responder₅₀rate from month 3 to month 12²

• All three studies show durability of the treatment effect to 24 months as evidenced by proportion Responder₅₀¹

• 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

• Superiority was shown for Solesta vs. Sham at 6 months¹

• 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

• Treatment with Solesta was associated with high response rates in all 3 clinical studies at 6, 12 and 24 months¹

• 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

• 3X greater improvement in Fecal Incontinence Quality of Life (FIQOL) Lifestyle score for patients receiving Solesta vs sham¹

• >50% improved Embarrassment and Coping/Behavior scores at 12 months¹ 

• 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

• 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.)

• Solesta is unlikely to impede future procedures

• 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: 

• a pivotal, prospective, multicenter, randomized, sham-controlled double-blind study of 206 patients conducted under an Investigational Device Exemption (IDE; Pivotal study), 

• a prospective, multicenter, open-label study of 115 patients conducted outside the United States (Open-Label study), and 

• 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. 

• 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.