Efficacy & Quality of Life Overview

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 days1,3

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. 

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

  1. Solesta [Package Insert]. Santa Barbara, CA: Palette Life Sciences.

  2. Solesta Post-Market Approval P100014; 2011. 

  3. 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.

  4. 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.