Correlation of Digital Rectal Examination and Anorectal Manometry with Patient-Reported Outcomes Among Women with Fecal Incontinence.

ABSTRACT

INTRODUCTION AND HYPOTHESIS: Standardized digital rectal examination (DRE) correlates with anorectal manometry (ARM) measures. However, less is known about the relationship between DRE/ARM measures and patient-reported outcomes (PROs), especially among women with fecal incontinence (FI). Our aims were to evaluate associations between DRE and ARM measures and compare PROs with diagnostic evaluation measures for women with FI. METHODS: We analyzed data from the parent clinical trial, Controlling Anal incontinence by Performing Anal exercises with Biofeedback or Loperamide (CAPABLe). We pooled data from randomized women who completed standardized ARM, DRE, and validated PROs at baseline and 12 and 24 weeks post-treatment initiation. PROs included FI severity, impact on quality of life, and bowel diary data. We analyzed ARM pressure and volume data and DRE using the Digital Rectal Examination Scoring System (DRESS) resting and squeeze mean scores. We used Spearman Rank Correlation to measure associations between the ARM measures and mean DRESS scores, and between PROs and ARM/DRESS scores. RESULTS: Among 291 randomized women with ARM and DRE data, the correlation between DRESS and ARM resting measures was 0.196 (p<0.001) and between squeeze measures was 0.247 (p<0.001). At most timepoints, PROs more consistently correlated with squeeze ARM pressures and squeeze DRESS scores than resting measures. CONCLUSIONS: We found weak correlations between ARM and DRE measures and between those measures and PROs. Although DRE and ARM are commonly used diagnostic measures among women with FI, the weak correlations with patient-reported symptoms raises questions about their utility in clinical care.