Anal plugs for the management of fecal incontinence in children and adults: a randomized control trial. Anal plug for faecal incontinence. A new polyurethane anal plug in the treatment of incontinence after anal atresia repair.
To evaluate the contribution of the anal plug to the management of fecal incontinence in children and adults.
                Effective management of fecal incontinence remains problematic. Previous studies of an anal plug have yielded conflicting results.
                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.
                Thirty-one intervention and 17 control patients were recruited. Fecal incontinence was due to 1 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.
                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. Despite the availability of pharmacological, behavioural and surgical treatments for faecal incontinence, many patients remain symptomatic. There are few devices designed specifically to cope with this, and perineal pads are inefficient and unacceptable for many patients. This study aimed to evaluate a new device in patients with intractable faecal incontinence.
                Two sizes of a purpose-designed anal plug were evaluated in 20 patients with intractable faecal incontinence for solid or liquid stool. Each plug size was tested for 2 weeks, with patients completing a structured questionnaire after each size.
                The majority [14/20] could not tolerate a plug due to discomfort. Four patients (20%) wished to continue to use a plug on a regular basis after the study, and two others on an occasional basis. However, for this minority who could tolerate a plug, it was highly successful at controlling faecal incontinence. There was no clear preference for the smaller or larger plug. There was no association between comfort in using the plug and anorectal sensitivity as measured by electrophysiological tests. It was not possible to predict which patients would benefit from plug use.
                The anal plug is effective in controlling faecal incontinence and is well tolerated in a minority of patients. Evaluation quickly reveals whether the patient will find it an effective and acceptable option. This device therefore offers a further management option for patients with faecal incontinence. 38 totally or partially incontinent patients following imperforate anus repair (age 6-15 years) tested a new polyurethane (PU) anal plug against another, widely used anal plug (PVA) in a randomized crossover trial. Plugs were tested 3 weeks each, data concerning bowel habits, handling and plug-related problems were collected by questionnaire before trial, at time of product change and after trial.
                15 of 38 patients did not complete the protocol, among them 6 with anal canal diameters too small for the smallest plug. During plug use, patients experienced enhanced awareness of repletion and urge. Stool consistence did not change in 82% of patients. There were no changes in children constipated prior to study (n = 8/23). 12,123 children were absolutely clean during use of either plug. 15 patients (68%) using the PU plug and 10 (45%) using the PVA plug felt secure from soiling during plug use. 74% of patients preferred the PU plug. Painful plug insertion, a feeling of pressure inside the anal canal and painful plug removal were reported with both plugs, but were less frequent with the PU plug.
                Anal plugs, regardless of their make, offer absolute cleanliness for periods of several hours to 66% of our incontinent patients. The PU plug (Conveen, Coloplast) is preferred by the patients and offers greater security than the PVA plug.
The available data were limited and incomplete, and not all pre-specified outcomes could be evaluated. Consequently, only tentative conclusions are possible. The available data suggest that anal plugs can be difficult to tolerate. However, if they are tolerated they can be helpful in preventing incontinence. Plugs could then be useful in a selected group of people either as a substitute for other forms of management or as an adjuvant treatment option. Plugs come in different designs and sizes; the review showed that the selection of the type of plug can impact on its performance.