Exploring the Impact of a Mobile Health Solution for Postpartum Pelvic Floor Muscle Training: Pilot Randomized Controlled Feasibility Study

Abstract

Background: The postpartum period is a vulnerable time for the pelvic floor. Early implementation of pelvic floor muscle exercises, appropriately termed as pelvic floor muscle training (PFMT), in the postpartum period has been advocated because of its established effectiveness. The popularity of mobile health (mHealth) devices highlights their perceived utility. The effectiveness of various mHealth technologies with claims to support pelvic floor health and fitness is yet to be substantiated through systematic inquiry.

Objective: The aim of this study was to determine the acceptability, feasibility, and potential effect on outcomes of an mHealth device purposed to facilitate pelvic floor muscle training among postpartum women.

Methods: A 16-week mixed methods pilot study was conducted to evaluate outcomes and determine aspects of acceptability and feasibility of an mHealth device. All participants received standardized examination of their pelvic floor muscles and associated instruction on the correct performance of PFMT. Those randomized to the iBall intervention received instructions on its use. Schedules for utilization of the iBall and PFMT were not prescribed, but all participants were informed of the standard established recommendation of PFMT, which includes 3 sets of 10 exercises, 3 to 4 times a week, for the duration of the intervention period. Quantitative data included the measurement of pelvic floor muscle parameters (strength, endurance, and coordination) following the PERFECT assessment scheme: Incontinence Impact Questionnaire scores and the Urogenital Distress Inventory (UDI-6) scores. Aspects of acceptability and feasibility were collected through one-to-one interviews. Interview transcripts were analyzed using Thorne's interpretive description approach.

Results: A total of 23 women with a mean age of 32.2 years were randomized to an intervention group (n=13) or a control group (n=10). Both groups improved on all measures. The only statistically significant change was the UDI-6 score within both groups at 16 weeks compared with baseline. There was no statistically significant difference between the intervention group and control group on any outcomes. Most participants using the iBall (n=10, 77%) indicated value in the concept of the mHealth solution. Technical difficulties (n=10, 77%), a cumbersome initiation process (n=8, 61%), and discomfort from the device (n=8, 61%) were reasons impeding intervention acceptability. Most participants (n=17, 74%) indicated that the initial assessment and training was more useful than the mHealth solution, a tenet that was echoed by all control group participants.

Conclusions: Our pilot study demonstrated the potential for mHealth solution-enhanced PFMT in the early postpartum period. Usability issues in hardware and software hindered feasibility and acceptance by the participants. Our findings can inform the redesign of mHealth solutions that may be of value if acceptability and feasibility issues can be overcome.

Trial registration: ClinicalTrials.gov NCT02865954; https://clinicaltrials.gov/ct2/show/NCT02865954.

Keywords: biofeedback; computer games; feasibility study; mobile health; pelvic floor; postpartum; wearable technology; wireless technology.

Figure 1

The mHealth iBall device. The iBall device consists of a Bluetooth antenna that sits outside of the body and 2 spherical compartments containing a battery and biofeedback sensor that sits within the vaginal canal.

Figure 2

The iBall App. Left: There are a number of activities that aid in engaging the pelvic floor. Right: The progress of the user can be tracked and monitored.