Does the EPI-NO device prevent perineal injury during childbirth?

Question

My wife suggested that we should use EPI-NO, a muscle training device to prevent perineal injury during childbirth.

Does anybody has data on the device? Is it effective?

The web-site has a studies section, that I can not read well, unfortunately.

Answer 1

I'm suspicious of their claims, but can find no concrete evidence to debunk or prove it.

The two medical papers that relate to the product were written by the exact same people, and both read like advertisements in places, going to unusual efforts to include a ® symbol with every mention of the product name. It also seems significantly odd that they'd submit both to the Australian / New Zealand OBGYN journal when both the company and the writers of the paper are German.

Looking at the statistics makes me even more suspicious. They measure the number of injuries sustained during different types of birth procedure for both users and non-users of EPI-NO. Each statistic is provided along with a p-value, which is a simple way of saying how statistically significant the observation is. However, they don't state their null hypothesis (it's implied but never explicitly stated), nor do they explain what their basis for the p-value was. The only two p-values that meet their exact threshold for significance are the two that show the product in a positive light. The other statistics show either very minor differences (well within random variance) or demonstrate that there was a higher incidence of injury when the device was used, but these are dismissed via spurious high p-values. The sample size of one of the studies was also only ~275 people, which isn't very high.

The primary promoter of the product, Dr. Eugen Ruckhäberle, is identified as an OBGYN expert, yet (as far as I can tell) he no longer works as a practising surgeon or doctor. He doesn't seem to be on staff at the OBGYN department at St. Georg Hospital, Leipzig any more. This isn't evidence of anything dodgy, but it may well mean that he is directly involved with the company.

I'd hoped to discover more about the company via the domain WHOIS registrant details, but it looks like a marketing company set up the domain for them.

All in all, it makes me suspicious as hell, but I sadly can't give you anything concrete to work on.