Improved Quality of Life

Inject Solesta: For improvements in quality of life that make a difference1

  • 3X greater improvement in Fecal Incontinence Quality of Life (FIQOL) Lifestyle score for patients receiving Solesta vs sham2

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

  • Solesta has no device-related restrictions that interfere with a patient’s quality of life2

Fecal Incontinence Quality of Life (FIQOL) Score3

The FIQOL score measures the effectiveness of therapy to correct Fecal Incontinence. The scale consists of 29 questions in four categories: Lifestyle, Coping & Behavior, Embarrassment and Depression & Self-Perception.

Category ranges: 1 to 4 for Lifestyle, Coping/Behavior, and Embarrassment; 1 to 6 for Depression/Self-Perception3

FIQOL Categories help to measure the effects of fecal incontinence on QOL3



 

pivotol study

From the multicenter, randomized, sham-controlled, double-blind, pivotal study. Patients aged 18-75 years where enrolled if they did not respond to conservative therapy, had a CCFIS of 10 or more, and had 4 or more solid or liquid fecal incontinence episodes in the 2 weeks prior to undergoing the procedure. Exclusion criteria included complete external sphincter disruption and significant mucosal prolapse. 

The FIQOL scale is a validated tool that is specifically designed to assess the impact of FI on a patient’s quality of life. In the blinded phase of the Pivotal study, improvement in FIQOL scores compared to baseline was observed in both the Solesta and Sham groups at 6 months. The change from baseline score was greater in the Solesta group than the Sham group in all four domains: Lifestyle ( =0.22), Coping/Behavior ( =0.25), Depression/Self-perception ( =0.09) and Embarrassment domains ( =0.16). In the Open-Label study, FIQL scores showed a similar improvement. The Proof-of-Concept study did not evaluate FIQOL.1


 

 

Find out more about the clinical safety and tolerability


 


 

References

  1. 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.

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

  3. 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;43:9–16.

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