Dependable Results

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

  • 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

  • At 36 months, FI episodes remained reduced by 52.2%

More Accident Free Days1

  • All 3 studies show an increase in number of FI free days with Solesta

  • There was  ~2X increase of incontinence free days

  • 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

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

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

  • 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

  • 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

  • You may resume limited physical activity immediately

  • 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.)

  • Solesta is unlikely to impede future procedures

 

 

 

Learn more about Fecal Incontinence


 

References

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

  2. Solesta Post-Market Approval P100014; 2011.