ArticleClinical and experimental gastroenterology2016
Identifying factors associated with clinical success in patients treated with NASHA(®)/Dx injection for fecal incontinence.
Article in Clinical and experimental gastroenterology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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1 citing paper in PubMed, 1 citations in OpenAlex.
- Evaluation of the Fecal Incontinence Quality of Life Scale (FIQL) using item response theory reveals limitations and suggests revisions.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2018Article
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3 authors at 1 institution in 1 country.
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No grant is acknowledged in the PubMed record.
Abstract
purposeInjection with the bulking agent consisting of non-animal stabilized hyaluronic acid/dextranomer (NASHA(®)/Dx) is well tolerated and efficacious for the treatment of fecal incontinence (FI); however, the patient population that may derive maximum benefit has not been established. This post hoc responder analysis assessed demographic and baseline characteristics predictive of responsiveness to NASHA/Dx treatment.
methodsAdults with a Cleveland Clinic Florida fecal incontinence score (CCFIS) ≥10 were randomized to receive NASHA/Dx or sham treatment. The primary end point was response to treatment (ie, decrease from baseline of ≥50% in number of FI episodes) at 6 months; a prespecified secondary end point was change in fecal incontinence quality of life (FIQL) score at 6 months. Post hoc subgroup analyses were performed for baseline and demographic characteristics and prior FI treatments.
resultsOverall, response to treatment was significantly greater with NASHA/Dx versus sham injection (52.7% vs 32.1%; P=0.0089). All subgroups analyzed demonstrated evidence of improvement, favoring NASHA/Dx versus sham treatment for both response to treatment and change in the FIQL coping/behavior subscale score. For the primary end point, a significantly greater percentage of patients with CCFIS ≤15, FI symptoms ≤5 years' duration, or obstetric causes of FI responded to NASHA/Dx treatment versus patients receiving sham treatment (51.1% vs 28.3%, P=0.0169; 55.4% vs 25.7%, P=0.0026; and 53.6% vs 23.1%, P=0.0191, respectively). The mean change in the FIQL coping/behavior score significantly favored NASHA/Dx versus sham treatment for patients with CCFIS ≤15 (P=0.0371), FI symptoms ≤5 years' duration (P=0.0289), or obstetric causes of FI (P=0.0384). Patients without a history of specific FI treatments (eg, antidiarrheal medications, biofeedback, surgery) were more likely to respond to NASHA/Dx versus sham treatment for both end points.
conclusionAlthough all subgroups analyzed showed evidence of quantitative and qualitative benefit from NASHA/Dx therapy, patients with characteristics indicative of mild-to-moderate FI may exhibit the greatest benefit.
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