The EpiNo® Device: Efficacy, Tolerability, and Impact on Pelvic Floor—Implications for Future Research

Table 1

Published studies between 2001 and 2011 in chronological order, showing the study populations, sessions with the EpiNo , and outcomes.

Year of publication	Author	Type of study	Primary outcome	Inclusion criteria	Sessions	Study population	Follow-up	Results
2011	Shek et al. [20]	Prospective RCT; Single blinded	Does EpiNo reduce levator ani trauma?	Singleton, age over 18, uncomplicated pregnancy	37 w to delivery, up to 2 × 20 minutes daily	81 EpiNo users, 64 controls	3 months after delivery	(a) Reduced risk for avulsion of levator ani (6% versus 13%, ); (b) No difference in perineal tears and duration of second stage of labour
2009	Ruckhäberle et al. [21]	Multicenter prospective RCT; Single blinded	Does EpiNo reduce perineal trauma?	Singleton, primigravid	37 1/7 to delivery, minimum of 15 minutes daily	107 EpiNo users, 15 controls	3 months after delivery	(a) Higher incidence of intact perineum (37,4% versus 25.7%, ); (b) Tendency towards decreased episiotomy rate (41.9 versus 50.5%, ); (c) No difference in duration of second stage of labour, APGAR scores, Oxford grading of pelvic muscles, bladder neck mobility, and infections rates
2004	Kovacs et al. [22]	Observational; case-control	Effect of EpiNo on perineum	Primigravid	From 37 w to delivery, 15 minutes daily for 14 consecutive days	39 EpiNo users, 248 controls	Directly postpartum	(a) Intact perineum in 46% versus 17% (), perineal tears 28% versus 49% (), episiotomy 26% versus 34% (); (b) No difference in second-stage duration, incidence of instrumental delivery, or APGAR scores
2004	Kok et al. [24]	Case-control; (retrospective analysis of controls)	Episiotomy rate, perineal tear rate, and analgesic requirements postpartum	Primigravid, single pregnancy	36–38 weeks, 15 minutes daily for 14 days	20 EpiNo users, 60 controls	Directly postpartum	(a) Episiotomy 50% versus 93.3% (); (b) Perineal trauma 90.0% versus 96.6%,
2001	Hillebrenner et al. [23]	Prospective observational single blinded case-control	Episiotomy and perineal tear rates, duration of second stage of labour, analgesic requirements, epidural anesthesia rates, and fetal outcome	Primigravid or after primary cesarean section, no infection	From 38 0/7 to delivery, 10 minutes daily	45 EpiNo users, 45 controls	Directly postpartum	(a) Episiotomy 82% versus 47% (); (b) No significance in perineal tears (); (c) Intact perineum 9 versus 49%; (d) Higher 1-minute APGAR scores (); (e) Second-stage duration 29 ± 25 min versus 55 ± 54 min (); (f) Less epidural (15.6% versus 35.6%, )