Discussion
pelvic floor dysfunction, Fecal incontinence, obstructive defecation, pudendal neuropathy, pelvic organ prolapse
FECAL INCONTINENCE
The NOTABLe trial is the second multicenter, randomized, masked trial of PTNS for treatment of ABL to report no benefit over sham stimulation [This heterogeneity in outcome status is notable, as it highlights the importance of the definition utilized when assessing ABL treatment efficacy and suggests potential variability in standardized research trials compared with common clinical intervention. Indeed, prior research of pelvic floor dysfunction has revealed discordance in the patient assessment of treatment success compared with objective measures with respect to surgical treatment of pelvic organ prolapse [With respect to potential differential efficacy of PTNS vs sham, although there were isolated risk factors that met the significance criteria in our analyses, they were not consistent across our outcome measures or differential response thresholds. As such, our study failed to identify clinically meaningful differences in the application of PTNS to any subgroup of women with ABL. Notably, however, this analysis was exploratory in nature, did not include qualitative assessments and the study was not designed or powered to find differences in response between subgroups. Additionally, this study did not perform sophisticated characterization of anal sphincter defects, rectal tone, and compliance or pudendal neuropathy. Though not part of the NOTABLe study design, high-resolution anorectal manometry with rectal sensory and compliance testing may have helped to characterize individuals with affected rectal tone and compliance who may have differing responses to treatment. Additionally, NOTABLe did not ascertain through questionnaire or structured interview baseline obstructive defecation (OD) symptoms of difficulty with rectal evacuation, excessive straining, requirement for regular digitation, or a sensation of incomplete emptying. As such, we cannot support or refute the negative association between OD and PTNS treatment outcomes identified in a post-hoc subgroup analysis of the CONFIDeNT trial [Our study findings are strengthened by the use of a large number of participants with uniform, validated data collection from a multicenter, randomized trial. However, given the inclusion criteria applied to the NOTABLe trial, the results are not generalizable to men or to individuals with less-severe ABL undergoing behavioral or pharmacological treatment. Fecal incontinence is known to have a significant impact on patient wellbeing and quality of life, but those influences are multifactorial and individualized [