Impact of Bowel Diary Completion and Education on Fecal Incontinence Severity.

OBJECTIVE

This study aimed to determine the effect of a run-in period on fecal incontinence (FI) symptom severity.

STUDY

DESIGN

This study conducted a planned secondary analysis of the run-in period to a study evaluating the effect of 12-week treatment with percutaneous tibial nerve stimulation versus sham in reducing FI severity in women. All participants completed a 4-week run-in period designed to exclude from randomization women whose symptoms reduced below the eligibility threshold after receiving education on FI and completing bowel diaries. Change in St Mark's (Vaizey) score and weekly FI episodes during the run-in period (week 1 vs week 4) was assessed.

RESULTS

One hundred and eighty-five women completed the run-in period. The mean St Mark's (Vaizey) score was 17.8 ± 2.6 and 16.9 ± 3.5 at week 1 and week 4, respectively. There was no significant change in the St Mark's (Vaizey) score from week 1 to week 4 (mean change, -0.93 [95% CI, -1.56 to -0.31]). The average number of FI episodes per week did not change significantly between week 1 and week 4, nor did other bowel diary measures. Only 11 (6%) women became ineligible for the trial following the run-in period, all of whom had baseline St Mark's (Vaizey) scores of 18 or lower.

CONCLUSIONS

Completion of a bowel diary and receiving education on FI during the 4-week run-in period did not significantly affect symptom severity in women with FI. Only 6% of women became ineligible for participation following the run-in period, suggesting that, in a refractory population, a run-in period may have minimal effect.