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

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


2a-i) Problem and the type of system/solution
Problem: "The postpartum period is a vulnerable time for the pelvic floor [1]. Dysfunction of the pelvic floor musculature is associated with urinary and fecal incontinence, pelvic organ prolapse, and lumbopelvic pain [2][3][4][5][6][7][8]. Prevalence data vary; however, approximately 23% of postpartum women report either urinary or fecal incontinence [63]. " "PFMT can be effectively initiated with brief instruction through digital palpation of the pelvic floor muscles as associated feedback related to the muscle contraction completed [20]. It is established that, in the absence of providing adequate instruction and biofeedback, it is difficult for women to accurately perform pelvic floor muscle exercises [22,23]. Existing literature suggests that best practices for the prevention and management of pelvic floor dysfunction are not routinely implemented [24,25]. There is no universally accepted protocol for the initiation of PFMT in the postpartum period. This represents a research-practice gap." Solution: "A proactive approach to pelvic health is needed as are strategies to overcome barriers contributing to this research-practice gap. Mobile health (mHealth) solutions may provide strategies to close the gap. mHealth solutions are defined by the World Health Organization [26] as the "medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices, personal digital assistants, and other wireless devices" [26]." "This pilot randomized controlled study aimed to evaluate the feasibility and acceptability of an mHealth solution (iBall) as a rehabilitation tool to support PFMT efforts in the early postpartum period. The iBall is a device that, upon insertion into the vaginal canal, can detect the strength and muscular endurance of pelvic floor muscles. The results are displayed in the accompanying mobile app that incorporates various training routines and gaming options. It aims to encourage both adherence to and improvement of outcomes of PFMT. Specifically, we sought to assess the feasibility, acceptability, and effectiveness of outcomes of an mHealth device (iBall) compared with PFMT instruction alone in the early postpartum period." 2a-ii) Scientific background, rationale: What is known about the (type of) system "The current market for mHealth technologies is growing, including applications marketed for pelvic floor rehabilitation and fitness [53][54][55][56]. These mHealth technologies may represent innovative modalities to support pelvic floor muscle fitness. Claims and proposed benefits of these mHealth solutions, compared with standard care, are based on concepts and have not been substantiated by scientific investigation. Overall, the body of evidence on the effectiveness of mHealth technology is, in general, weak [27]."

Does your paper address CONSORT subitem 2b?
Yes -purpose and aim clearly explained. METHODS 3a) CONSORT: Description of trial design (such as parallel, factorial) including allocation ratio "A 16-week mixed-methods pilot study was conducted to evaluate outcomes and This study was done in a 1:1 allocation ratio using random number assignments. Allocations were placed in sealed envelopes that were opened after the initial physical assessment at the time of randomization. Women having a vaginal or cesarean birth within 21 weeks of delivery were included. To maximize generalizability, the exclusions were made based on the individuals' inability to understand and read English and direction from their caregivers to not insert anything into their vagina." "An initial phone screening was conducted by a research assistant. Interested and eligible participants then met with a research assistant for further discussion and to obtain informed consent. The start time of the intervention took place in the early postpartum period, primarily during the fourth trimester (from week 6 postpartum to week 13 postpartum)." 3b) CONSORT: Important changes to methods after trial commencement (such as eligibility criteria), with reasons None 3b-i) Bug fixes, Downtimes, Content Changes "We were evaluating these aspects so the findings reflect these items. Most participants using the iBall 10(77%) indicated value in the concept of the mHealth solution. Technical difficulties 10(77%), a cumbersome initiation process 8(61%), and discomfort from the device 8(61%) were reasons impeding intervention acceptability. Most participants 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."

4a) CONSORT: Eligibility criteria for participants
Yes -in methods.
"Women in the third trimester of pregnancy, attending local midwifery practices, were invited to participate in the study." 4a-i) Computer / Internet literacy No 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: In person assessments.
Following assessment, subjects received their randomization allocation. Subjects randomized to the iBall group received additional instruction and training from the research assistant. Follow-up assessments were completed by the same assessors (SD and DF). A consistent process for assessment procedures including cueing during the pelvic floor muscle testing and instruction for the performance of pelvic floor exercises was established. All participants received instruction for the correct performance of pelvic floor muscle exercises via digital palpation. 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 duration of the intervention period [28]. Neither assessor was at any time, during the conduct of the study, aware of which group a subject was allocated.

4a-iii) Information giving during recruitment
Posters were used to facilitate recruitment. All initial study procedures took place in the early postpartum period (within the fourth trimester, the first 13 weeks postpartum). Following initial screening and confirmation of eligibility, participants were prospectively randomized to an mHealth-assisted PFMT intervention or PFMT instruction only ( Figure 1). The study was approved by the Hamilton Integrated Research and Ethics Board.

4b) CONSORT: Settings and locations where the data were collected
Yes 4b-i) Report if outcomes were (self-)assessed through online questionnaires no online questionnaires used

4b-ii) Report how institutional affiliations are displayed
In association with authors only.

5) CONSORT: Describe the interventions for each group with sufficient details to allow replication, including how and when they were actually administered 5-i) Mention names, credential, affiliations of the developers, sponsors, and owners
The iBall (ChunShuiTang Co Ltd) is an interactive mHealth device designed to facilitate PFMT. The iBall device is a US Federal Communications Commission-certified [38] and European Conformity-marked [39,40] device that, upon insertion into the vaginal canal, can detect the strength (power generation) and associated muscular endurance of pelvic floor muscles. Currently, iBall has been approved for consumer use in Europe and China. This information detected from the sensors within the device are transmitted via Bluetooth to a smartphone app that guides users in various exercise programs. The device is shown in Figure 1. It comprises 2 spherical compartments and a Bluetooth antenna for wireless communication with the smartphone. The whole device including the antenna is encapsulated in waterproof medical grade silicone casing. The battery and charging circuit are in the top spherical compartment with a waterproof charging port in the silicone encapsulation. The sensor and biofeedback motors are in the bottom compartment, which also contains a power button under the silicone casing. The user can press and hold the power button to turn on/off the device. The antenna also serves as a handle to push in and pull out the device from the vaginal canal. In this study, each participant in the intervention group will receive an iBall device along with an already paired smartphone (iPhone 5e) with the mobile app installed and tested with the device. Both the iBall device and the smartphone were originally fully charged, and power will last a few days depending on usage level.
These quantitative results are saved with a time stamp in the mobile app. The data can also be automatically uploaded to an encrypted cloud storage server through an opt in option. In this study, the participants have consented to upload their usage data for the study with the uploading feature enabled. Each user's study smartphone app has already been configured with a unique randomly generated user account and log-in credential. Only the research team has a securely saved lookup table linking the user account and the identity of the participants. The cloud-stored data can be downloaded as structured data files (in American Standard Code for Information Interchange/ASCII format) for further analysis. The original consumer product has a Web-based profile function allowing the users to access their data on the cloud server and interact (by users' choice) with other users in a Web-based community. This feature is only available in Chinese and was permanently disabled in the clinical study version of the smartphone app. As a result, although the device and app have the capability of Web access to their usage data and interacting with other users, such functionalities were disabled in devices used in this study. The iBall device is currently marked as a consumer electronics gaming device. Some quantitative results (eg, power or contracting force) are not calibrated for absolute pressure measurements. The results of metrics obtained from the devices are not included in this study.

5-ii) Describe the history/development process
Not applicable.

5-iii) Revisions and updating
Discussed in the implications section.
The iBall is a dynamic and interactive mHealth solution that has the capacity to enhance PFMT. With the capacity to provide biofeedback, record data, and track progress, iBall has the potential to increase motivation and adherence. Furthermore, the iBall device and smartphone app have the capability of remote storage of usage data for record keeping and additional analysis. The Web-based data feature is designed for further gamification apps. Owing to research ethics app constrains (Hamilton integrated Research Ethics Board/HiREB has concerns regarding data access), the Web-based interaction features were disabled in this study. Nonetheless, based on experiences from gamification of wearable fitness devices [62], we foresee that such an interactive design feature will generally improve user motivation and adherence. Our study has highlighted several aspects that are important for mHealth solutions to be acceptable and feasible for pelvic floor rehabilitation in the early postpartum period. Convenience, user friendliness, reliable technology, accurate biofeedback, and user progress tracking were identified as being important features (Table 7). Effective mHealth solutions require consideration of the understanding and capabilities of end users (patients and practitioners) to use the technology [49]. End user engagement throughout the design and development processes help ensure that mHealth solutions are acceptable and feasible by fitting within the end user's context [50]. Our study results emphasize the need of end user input in the design of mHealth solutions for pelvic floor muscle function/dysfunction. Acceptability and feasibility need to be established before testing the efficacy of potential pelvic floor rehabilitation mHealth solutions in fully powered randomized controlled trials (RCTs).

5-iv) Quality assurance methods
Limitations explicated clearly and attention to related to qualitative and quantitative methods assurance measures attended to.
A significant limitation of this study is the small sample size. We had challenges with both recruitment and follow-up. Both contributed to poor feasibility. The small sample size confers caution to interpreting the statistical findings. As we did not conduct a priori sample size calculations, the results should be considered exploratory. We acknowledge possible ceiling effects related to the outcome measures. The low burden of pelvic floor dysfunction at baseline and limitations related to the UDI-6 and IIQ-7 in the postpartum period resulted in poor discriminatory powers of the measurements. The UDI-6 and IIQ-7 are well-established psychometrically sound self-report questionnaires that were developed for symptomatic patients and not healthy women in the early postpartum period. A recent review of 33 urogynecology questionnaires confirmed that none target postpartum women and that tools specific to this population are needed [51].

5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used
All provided as figures.

5-vii) Access
Participants randomized to the intervention group received additional instruction on how to use the mHealth solution (iBall) by a research assistant. Participants were shown how to use the device and were familiarized with the associated app on the associated smartphone. Maintenance was informed as per manufacturers recommendations, which involved washing the device with warm water and a natural soap and storing it in the case it came in. Participants then used the device according to their own schedule (eg, when to exercise, frequency, and how long). The PFMT with iBall occurs within the context of playing a variety of games. Participants in the intervention group received a booster session, midway through the intervention period. This booster session consisted of an email sent by a research assistant reminding participants of features of the iBall and benefits of postpartum pelvic floor muscle exercise as a means of self-management support. The use of booster sessions to facilitate self-management support has been shown to be a useful procedure in rehabilitation interventions [29].

5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework
The iBall (ChunShuiTang Co Ltd) is an interactive mHealth device designed to facilitate PFMT. The iBall device is a US Federal Communications Commission-certified [38] and European Conformity-marked [39,40] device that, upon insertion into the vaginal canal, can detect the strength (power generation) and associated muscular endurance of pelvic floor muscles. Currently, iBall has been approved for consumer use in Europe and China. This information detected from the sensors within the device are transmitted via Bluetooth to a smartphone app that guides users in various exercise programs. The device is shown in Figure 1. It comprises 2 spherical compartments and a Bluetooth antenna for wireless communication with the smartphone. The whole device including the antenna is encapsulated in waterproof medical grade silicone casing. The battery and charging circuit are in the top spherical compartment with a waterproof charging port in the silicone encapsulation. The sensor and biofeedback motors are in the bottom compartment, which also contains a power button under the silicone casing. The user can press and hold the power button to turn on/off the device. The antenna also serves as a handle to push in and pull out the device from the vaginal canal. In this study, each participant in the intervention group will receive an iBall device along with an already paired smartphone (iPhone 5e) with the mobile app installed and tested with the device. Both the iBall device and the smartphone were originally fully charged, and power will last a few days depending on usage level. They both require periodic charging by the participants at home during the study period. Once inserted, the user has several interactive games or activities to choose from on the corresponding app on their smartphone (Figure 2). Their progress can also be tracked, both as a score in the game and as a measure of power, endurance, repetitions, and contracting force (Figure 2).

5-ix) Describe use parameters
Following assessment, subjects received their randomization allocation. Subjects randomized to the iBall group received additional instruction and training from the research assistant. Follow-up assessments were completed by the same assessors (SD and DF). A consistent process for assessment procedures including cueing during the pelvic floor muscle testing and instruction for the performance of pelvic floor exercises was established. All participants received instruction for the correct performance of pelvic floor muscle exercises via digital palpation. 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 duration of the intervention period [28].

5-x) Clarify the level of human involvement
Following assessment, subjects received their randomization allocation. Subjects randomized to the iBall group received additional instruction and training from the research assistant. Follow-up assessments were completed by the same assessors (SD and DF). A consistent process for assessment procedures including cueing during the pelvic floor muscle testing and instruction for the performance of pelvic floor exercises was established. All participants received instruction for the correct performance of pelvic floor muscle exercises via digital palpation. 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 duration of the intervention period [28]. Neither assessor was at any time, during the conduct of the study, aware of which group a subject was allocated.

5-xi) Report any prompts/reminders used
Booster session used.
"Participants randomized to the intervention group received additional instruction on how to use the mHealth solution (iBall) by a research assistant. Participants were shown how to use the device and were familiarized with the associated app on the associated smartphone. Maintenance was informed as per manufacturers recommendations, which involved washing the device with warm water and a natural soap and storing it in the case it came in. Participants then used the device according to their own schedule (eg, when to exercise, frequency, and how long). The PFMT with iBall occurs within the context of playing a variety of games. Participants in the intervention group received a booster session, midway through the intervention period. This booster session consisted of an email sent by a research assistant reminding participants of features of the iBall and benefits of postpartum pelvic floor muscle exercise as a means of self-management support. The use of booster sessions to facilitate self-management support has been shown to be a useful procedure in rehabilitation interventions [29]."

5-xii) Describe any co-interventions (incl. training/support)
Participants were instructed on the use of iball prior to the study. 6a) CONSORT: Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed The assessment included completion of 2 self-report outcome measures and a digital pelvic floor examination, inclusive of initiating PFMT by one of the 2 assessors. The 2 validated self-report measures that were administered were the Urogenital Distress Inventory (UDI-6) [30] and the Incontinence Impact Questionnaire (IIQ-7), which are shown in Table 2. The pelvic floor muscle examination followed the PERFECT scheme [8]. Clinically relevant changes in the PERFECT score was predetermined as an improvement of 20% based on previously published minimal clinical improvement thresholds. 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed no online questionnaires used. 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored self-report through one-to-one interviews and corroborated through analytic data. 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Mixed methods pilot feasibility study -one to one interview data represented a large part of the study data. 6b) CONSORT: Any changes to trial outcomes after the trial commenced, with reasons Yes 7a) CONSORT: How sample size was determined 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Not important given feasibility study.

7b) CONSORT: When applicable, explanation of any interim analyses and stopping guidelines
The assessment included completion of 2 self-report outcome measures and a digital pelvic floor examination, inclusive of initiating PFMT by one of the 2 assessors. The 2 validated self-report measures that were administered were the Urogenital Distress Inventory (UDI-6) [30] and the Incontinence Impact Questionnaire (IIQ-7), which are shown in Table 2. The pelvic floor muscle examination followed the PERFECT scheme [8]. Clinically relevant changes in the PERFECT score was predetermined as an improvement of 20% based on previously published minimal clinical improvement thresholds. 8a) CONSORT: Method used to generate the random allocation sequence computer generated. 8b) CONSORT: Type of randomisation; details of any restriction (such as blocking and block size) computer generated -no restrictions. 9) CONSORT: Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Computer generated -assessors blind. 10) CONSORT: Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Research assistant 11a) CONSORT: Blinding -If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how 11a-i) Specify who was blinded, and who wasn't Researchers and assessor were blind. 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Participants knew what group they were in. 11b) CONSORT: If relevant, description of the similarity of interventions Both involved education related to pelvic floor muscle training. 12a) CONSORT: Statistical methods used to compare groups for primary and secondary outcomes There was no statistically significant difference between the groups for change scores (ie, 16-week score minus baseline score) for any measure (Table 5). The predetermined clinically relevant difference in PERFECT score of 20% was not achieved. Both the intervention and the standard care groups showed improvement on all outcome measures: PERFECT criteria, UDI-6, and the IIQ-7 at 16 weeks compared with baseline ( Table 6). The UDI-6 score was the only outcome that achieved statistical significance in both groups.