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The WOMEN-UP Solution, a Patient-Centered Innovative e-Health Tool for Pelvic Floor Muscle Training: Qualitative and Usability Study during Early-Stage Development.

ABSTRACT: e-Health may enhance self-management of pelvic floor muscle training (PFMT) to treat stress urinary incontinence (SUI). It is crucial to involve patients in planning, developing and monitoring the optimal e-Health solution. This research aims to describe patient-centered innovation in an early developmental stage of the WOMEN-UP solution. We conducted a qualitative study through a self-developed questionnaire in 22 women with SUI, to define system requirements from a patient's perspective. The first prototype of the WOMEN-UP solution was developed. It was tested by 9 patients in a usability study (think-aloud protocol and retrospective interviews). Patient preferences regarding the possible use of an e-Health solution with serious games for PFMT were: (1) to receive feedback about PFMT; (2) convenient home-use; (3) increasing motivation; (4) available in medical centers. Identified usability aids (31) reassured our design-development plan, which considered the biofeedback and serious games as key factors. Patient's perspective detected some unexpected issues related to the calibration and serious games, involving a change in the ongoing development to get an improved WOMEN-UP solution; the value of patient-centered innovation during the development of an e-Health solution for PFMT (WOMEN-UP solution). To identify patients' unmet needs, we proposed a longitudinal approach for the future eHealth-related patient-centered innovations.

SUBMITTER: Angles-Acedo S

PROVIDER: S-EPMC8345479 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature

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The WOMEN-UP Solution, a Patient-Centered Innovative e-Health Tool for Pelvic Floor Muscle Training: Qualitative and Usability Study during Early-Stage Development.

Anglès-Acedo Sònia S López-Frías Lorena L Soler Vicenç V Alonso Joan Francesc JF Kastelein Arnoud W AW Graaf Boris C de BC Vodegel Eva V EV Tervo Jaana J Baban Adriana A Espuña-Pons Montserrat M On Behalf Of The Women-Up Consortium

International journal of environmental research and public health 20210723 15

e-Health may enhance self-management of pelvic floor muscle training (PFMT) to treat stress urinary incontinence (SUI). It is crucial to involve patients in planning, developing and monitoring the optimal e-Health solution. This research aims to describe patient-centered innovation in an early developmental stage of the WOMEN-UP solution. We conducted a qualitative study through a self-developed questionnaire in 22 women with SUI, to define system requirements from a patient's perspective. The f ...[more]

PMID: 34360093

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Project description:BackgroundThe 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.ObjectiveThe 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.MethodsA 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.ResultsA 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.ConclusionsOur 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 registrationClinicalTrials.gov NCT02865954; https://clinicaltrials.gov/ct2/show/NCT02865954.

Project description:BackgroundTo date, the focus of pelvic floor muscle training for women suffering from stress urinary incontinence has been on voluntary contractions although involuntary pelvic floor muscle contractions are crucial to guarantee continence in high-impact situations typically triggering this condition. The authors developed 2 pelvic floor muscle home training programs, one including standard voluntary pelvic floor muscle training and one including involuntary reflexive pelvic floor muscle training.ObjectiveThis study aimed to test 2 pelvic floor muscle home training programs regarding maintenance of effects of a previous 16-week intervention in terms of stress urinary incontinence symptoms (International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence short form, modified 20-minute pad test), impact on quality of life (Lower Urinary Tract Symptoms Quality of Life module), and digitally assessed pelvic floor muscle strength.Study designThis trial was a continuation of a previously published triple-blind prospective randomized controlled trial with a 6-month evaluation endpoint with 2 intervention groups (experimental group with involuntary reflexive home pelvic floor muscle training and control group with standard voluntary home pelvic floor muscle training).ResultsFrom the originally included 96 randomized and allocated participants (experimental group=46, control group=46), 33 control and 27 experimental participants completed the 6-month follow-up. From post-16-week physiotherapy intervention to 6-month follow-up (home pelvic floor muscle training), there were statistically significant improvements in pelvic floor muscle strength (control and experimental group), and no difference in the International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence short form and pad test, or the Lower Urinary Tract Symptoms Quality of Life module Part B (control and experimental group) and Part A (control group). However, there was a statistically significant improvement in the Lower Urinary Tract Symptoms Quality of Life module Part A (experimental group). At no point in time (pre, post, follow-up) was there any statistically significant difference between the groups.ConclusionBoth groups could maintain their intervention training effects. This trial investigated involuntary reflexive pelvic floor muscle training alone, which proved to be an effective alternative to standard voluntary pelvic floor muscle training for maintenance of training effects among women suffering from stress urinary incontinence.

Project description:PurposeUrge urinary incontinence is a major problem, especially in the elderly, and to our knowledge the underlying mechanisms of disease and therapy are unknown. We used biofeedback assisted pelvic floor muscle training and functional brain imaging (functional magnetic resonance imaging) to investigate cerebral mechanisms, aiming to improve the understanding of brain-bladder control and therapy.Materials and methodsBefore receiving biofeedback assisted pelvic floor muscle training functionally intact, older community dwelling women with urge urinary incontinence as well as normal controls underwent comprehensive clinical and bladder diary evaluation, urodynamic testing and brain functional magnetic resonance imaging. Evaluation was repeated after pelvic floor muscle training in those with urge urinary incontinence. Functional magnetic resonance imaging was done to determine the brain reaction to rapid bladder filling with urgency.ResultsOf 65 subjects with urge urinary incontinence 28 responded to biofeedback assisted pelvic floor muscle training with 50% or greater improvement of urge urinary incontinence frequency on diary. However, responders and nonresponders displayed 2 patterns of brain reaction. In pattern 1 in responders before pelvic floor muscle training the dorsal anterior cingulate cortex and the adjacent supplementary motor area were activated as well as the insula. After the training dorsal anterior cingulate cortex/supplementary motor area activation diminished and there was a trend toward medial prefrontal cortex deactivation. In pattern 2 in nonresponders before pelvic floor muscle training the medial prefrontal cortex was deactivated, which changed little after the training.ConclusionsIn older women with urge urinary incontinence there appears to be 2 patterns of brain reaction to bladder filling and they seem to predict the response and nonresponse to biofeedback assisted pelvic floor muscle training. Moreover, decreased cingulate activation appears to be a consequence of the improvement in urge urinary incontinence induced by training while prefrontal deactivation may be a mechanism contributing to the success of training. In nonresponders the latter mechanism is unavailable, which may explain why another form of therapy is required.

Project description:Background Pelvic Floor Muscle Training (PFMT) has been shown to be effective for pelvic organ prolapse in women, but its implementation in routine practice is challenging due to lack of adequate specialist staff. It is important to know if PFMT can be delivered by different staff skill mixes, what barriers and facilitators operate in different contexts, what strategies enable successful implementation and what are the underlying mechanisms of their action. PROPEL intervention was designed to maximise the delivery of effective PFMT in the UK NHS using different staff skill mixes. We conducted a realist evaluation (RE) of this implementation to understand what works, for whom, in what circumstances and why. Methods Informed by the Realist and RE-AIM frameworks, the study used a longitudinal, qualitative, multiple case study design. The study took place in five, purposively selected, diverse NHS sites across the UK and proceeded in three phases to identify, test and refine a theory of change. Data collection took place at 4 time points over an 18?month implementation period using focus groups and semi-structured interviews with a range of stakeholders including service leads/managers, senior practitioners, newly trained staff and women receiving care in the new service models. Data were analysed using thematic framework approach adapted to identify Context, Mechanism and Outcome (CMO) configurations of the RE. Results A heightened awareness of the service need among staff and management was a mechanism for change, particularly in areas where there was a shortage of skilled staff. In contrast, the most established specialist physiotherapist-delivered PFMT service activated feelings of role protection and compromised quality, which restricted the reach of PFMT through alternative models. Staff with some level of prior knowledge in women’s health and adequate organisational support were more comfortable and confident in new role. Implementation was seamless when PFMT delivery was incorporated in newly trained staff’s role and core work. Conclusion Roll-out of PFMT delivery through different staff skill mixes is possible when it is undertaken by clinicians with an interest in women’s health, and carefully implemented ensuring adequate levels of training and ongoing support from specialists, multi-disciplinary teams and management.

Dataset Information

The WOMEN-UP Solution, a Patient-Centered Innovative e-Health Tool for Pelvic Floor Muscle Training: Qualitative and Usability Study during Early-Stage Development.

Publications

The WOMEN-UP Solution, a Patient-Centered Innovative e-Health Tool for Pelvic Floor Muscle Training: Qualitative and Usability Study during Early-Stage Development.

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