38 totally or partially incontinent patients following imperforate anus rep
air (age 6-15 years) tested a new polyurethane (PU) anal plug against anoth
er, widely used anal plug (PVA) in a randomized crossover trial. Plugs were
tested 3 weeks each, data concerning bowel habits, handling and plug-relat
ed problems were collected by questionnaire before trial, at time of produc
t change and after trial.
Results: 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, pat
ients experienced enhanced awareness of repletion and urge. Stool consisten
ce did not change in 82% of patients. There were no changes in children con
stipated prior to study (n = 8/23). 12/23 children were absolutely clean du
ring use of either plug. 15 patients (68%) using the PU plug and 10 (45%) u
sing the PVA plug felt secure from soiling during plug use. 74% of patients
preferred the PU plug. Painful plug insertion, a feeling of pressure insid
e the anal canal and painful plug removal were reported with both plugs, bu
t were less frequent with the PU plug.
Conclusion: Anal plugs, regardless of their make, offer absolute cleanlines
s for periods of several hours to 66% of our incontinent patients. The PU p
lug (Conveen(R), Coloplast) is preferred by the patients and offers greater
security than the PVA plug.