This interventional cohort study received ethics approval from the local institutional research ethics board and all participants provided written informed consent prior to participating.
Thirty-six healthy females who had attended two training sessions where they learned from a certified Hypopressive trainer how to perform HEs in supine (using the Demeter HP) and standing (using the Athenas HP), and a data collection session as described below, were invited to participate. Nine declined due to the time commitment (n=4), having Covid-19 (n=4) and being pregnant (n=1), thus this study included twenty-seven participants.
The primary outcomes were PFM strength and stiffness. Secondary outcomes included transient changes observed in IAP, EMG amplitude of the LAMs and EAS, and pelvic morphology [levator plate length (LPL), bladder neck height (BNH) and levator plate angle (LPA)] observed on 2D transperineal ultrasound imaging (USI), acquired while participants performed HEs.
At each data collection session, LAM strength and stiffness were first recorded using a custom intravaginal dynamometer. Participants were positioned in supine and the lubricated arms of the dynamometer were inserted vaginally. The arms were opened to a diameter of 35mm, and, after baseline force had stabilized, standardized instructions were provided to perform a maximal voluntary contraction (MVC), by squeezing their PFMs as hard as possible into the resistance provided by the dynamometer. Next, the dynamometer arms opened from an initial diameter of 15mm to a diameter of 40mm at a rate of 15mm/s and were held there for 7s while the participant kept their PFMs relaxed. The arms were then closed. Each task was repeated three times.
Next, EMG electrodes were placed intravaginally over the LAMs and on the skin surface overlying the EAS, interfaced with Delsys (Boston, USA) differential preamplifiers and amplifiers. An IAP sensor [2] was inserted into the posterior fornix of the vagina. Participants performed three MVCs of their PFMs (maximal effort squeeze and lift). In random order, participants then performed three repetitions of the HE maneuver with and without the HP in supine and in standing while EMG, IAP and transperineal USI videos (GE Voluson S6; RAB6-D 4D convex curvilinear probe, GE, Toronto, Canada)] were acquired. This completed the data collection session.
After the first assessment, participants were instructed to complete the HE program at least three times per week, completing three repetitions of each of the four tasks, until returning to repeat the data collection session eight weeks later. Adherence was monitored via regular email correspondence.
EMG data were bias corrected, full-wave rectified, and smoothed using a 4th order, dual-pass low-pass Butterworth filter (cut-off 6 Hz). The peak of the EMG signal during each HE task was normalized to the highest peak achieved during the three PFM MVCs. The greatest change in IAP, levator plate length (LPL), levator plate angle (LPA) and bladder neck height (BNH) observed during each HE was retained for analysis.
All outcomes were tested for normality (Shapiro-Wilk test). Paired t-tests were used to determine whether strength and stiffness changed after training and univariate t-tests were used to determine whether there were changes in IAP, EMG activation and/or pelvic morphology during the performance of the HE in the HP after the training period. Separate two-way, repeated-measures ANOVAs were used to determine whether there was an effect of testing session, the HP, or the interaction between testing session and HP on transient changes in IAP, EMG amplitude (LAMs or EAS), BNH, LPL, or LPA observed during the HEs in each position (i.e., supine, standing). An adjusted alpha (α=0.05/8) was used.
A sample size of n=30 was determined apriori based on Brazalez-Navarro et al. [3] who reported moderate effect sizes for PFM tone (d=0.55) and strength (d=0.35) after an 8-week period of HE training.