Anal Plugs for the Management of Fecal Incontinence in Children and Adults: A Randomized Control Trial

Goals: To evaluate the contribution of the anal plug to the management of fecal incontinence in children and adults.

Background: Effective management of fecal incontinence remains problematic. Previous studies of an anal plug have yielded conflicting results.

Study: A randomized controlled trial was conducted. The intervention was the Conveen anal plug (Coloplast Limited) used for 12 months. Outcomes measures included: generic measures of child health [Functional Status II-R, Child Health Questionnaire (CHQ-PF50) and Dartmouth Primary Care Cooperative Information Project Charts]; generic measures of adult health for patients and carers (the SF-36, and Patient Generated and Carer Generated indices); condition-specific measures for adults and children; qualitative interviews, bowel charts, and diaries. The main outcome measure was a condition-specific score on a 0 to 100 scale, where 0 was the most severe and 100 was the least severe incontinence.

Results: Thirty-one intervention and 17 control patients were recruited. Fecal incontinence was due to I of 3 reasons: congenital, acquired, and neurogenic. At baseline, patients managed their condition preemptively or protectively. Intervention patients used the plug as a complete management substitute or as an adjunct to existing management. The majority of intervention respondents retained the plug most of the time. There was greater improvement from baseline in mean condition-specific score in intervention group compared with control group but this difference was not statistically significant (t test P = 0.053). Complete data analysis using analysis of covariance showed the mean difference between the treatment groups in condition-specific score of 9.9 (95% confidence interval-1.4, 21.1). Intention to treat analyses using imputation showed similar results. There was generally greater improvement in intervention groups subjects using other measures for children, adults, and carers.

Conclusions: The anal plug is of benefit to the majority of patients. It does not suit all eligible patients with in situ plug retention being a problem for some.