Assessing feasibility and maternal acceptability of a supervised Epi-no® protocol with duration of 4 weeks and daily frequency, in pregnant women

A feasibility study was conducted to address aspects of a supervised Epi-no® protocol provided to pregnant women attending antenatal physical therapy visits. The women were recruited consecutively from February to April 2022. 
The supervised Epi-no® protocol consisted of attending a daily four weeks supervised program using Epi-no®. Feasibility was assessed in terms of the recruitment capability, sample characteristics, data collection procedures, outcome measures, and acceptability (attendance to Epi-no® protocol visits, Epi-no® protocol adherence, participant experiences) of the programme.
Data were collected using self-reported questionnaires.

Among 16 women included, 9 (56%) attended five or more supervised Epi-no supervised sessions, and the mean number of sessions was twelve. All women declared to be completely satisfied with the program and its results and that it would be probable to recommend it to someone. Although adherence does not confirm it, all women considered the daily frequency adequate. 
When asked about the individual use of the device, 77.8% admitted being unable to use it autonomously, and 88.9% considered paying to acquire a service with these characteristics.

As for undesirable effects, only 2 (22.2%) users claimed to have experienced pain or discomfort during the procedure, and on no occasion did they cause them to drop out of the project.
In each session, the level of discomfort at insertion and expulsion of the device, on a scale from 0 to 10, where 10 corresponds to the maximum possible discomfort. The level of discomfort with balloon insertion was between 0 and 5, with a rating of 2 being the most frequently mentioned. The minimum value of discomfort when expelling the balloon was one, and the maximum was 6, with grade 4 being the most frequently applied.

A positive correlation was established between a higher number of sessions performed and a higher final diameter of the device (p=0.05 and r=0.666). The higher the frequency of sessions, the closer to the goal of 22 cm of the device.

No statistically significant differences were found in the number of sessions having a protective effect on the occurrence of episiotomy. However, the women who had a cesarean completed an average of 9 sessions, compared to the 14 performed by women who had a vaginal delivery.

Pregnant women accept a 4-week protocol of Epi-No, which is safe and can positively affect the elasticity of the perineal muscles. 

The daily frequency during the four weeks can be considered exhaustive, and it is pertinent to compare with protocols of 3 and 4 weekly sessions. Although the influence of the Epi-no® device in preventing perineal trauma was not statistically significant, the frequency of weekly sessions may be considered to be weekly sessions can be considered exhaustive, and it is pertinent to compare with protocols 3 and 4 weekly sessions.

Although the influence of the Epi-no® device in preventing perineal trauma was not statistically significant, and attendance was lower than expected, no anal sphincter injuries were reported.
However, a large-scale study would be necessary to understand its influence on peripartum data.

The supervised Epi-no® protocol was acceptable. The results and experiences from the current study may guide implementation and future studies on the effectiveness of the supervised Epi-no® protocol in preventing perineal trauma.