Hypothesis / aims of study
Parkinson’s Disease (PD) is the second most common neurodegenerative disorder worldwide. Beyond hallmark motor symptoms, pelvic floor disorders (PFD), including urinary incontinence and constipation, are highly disabling and often insufficiently managed [1]. First-line treatments such as pelvic floor muscle training (PFMT) rely on adherence, which may be reduced by invasive anal or vaginal biofeedback, causing discomfort and limiting access to care.
Non-invasive external biofeedback devices may help overcome these barriers. External pressure sensors have shown promising feasibility in both women and men [2], although their application in PD remains underexplored. Integrating these devices into established mHealth platforms, such as ParkinsonRehab®, already effective in neurological rehabilitation, may enhance adherence and expand pelvic floor care [3].
This study evaluates a non-invasive external biofeedback device (PelviTrainer), equipped with two pressure sensors for recording contraction from anterior and posterior pelvic floor, integrated with ParkinsonRehab® app for home-based pelvic floor rehabilitation. We aimed to assess feasibility, acceptability, and usability in a domestic setting.
Study design, materials and methods
This was a single-arm, non-controlled, quasi-experimental feasibility study including men and women with PD. Participants at baseline were trained to use the PelviTrainer and the dedicated PFMT section in ParkinsonRehab® app on their smartphone and received a vademecum with instructions for use and training. At this stage, participants filled in the Pelvic Floor Distress Inventory (PFDI-20) for baseline symptoms, a multiple-answer survey tool to collect socio-demographic data and their familiarity and awareness with pelvic floor muscles. Pressure was measured during dynamic pelvic floor contractions from anterior and posterior sensors.
Participants then performed 7 days of self-managed training via ParkinsonRehab®, receiving real-time biofeedback of their pelvic floor muscles. Post-intervention, usability and satisfaction were assessed using Numeric Rating Scale (NRS) and Likert scales. Numbers, percentages, means, and standard deviations were reported.
Results
Thirteen participants (9 men, 4 women; age 68 ± 9) were recruited. PFDI-20 scores and socio-demographic data are reported in Table 1. At baseline, 82% had heard about the pelvic floor, 62% reported uncertain or absent pelvic muscle proprioception, 42% reported knowing pelvic anatomy and functions, 38% could perceive their muscles during contractions, and 46% were unsure about performing an isolated pelvic floor contraction. Dynamic variation of posterior and anterior sensors during contractions is presented in Figure 1.
After the intervention, the NRS of satisfaction was 8.08. All participants felt at ease using the device and reported no physical discomfort or embarrassment, expressing a willingness to continue the treatment and would recommend the device to others. All participants reported that the device could be useful for pelvic floor rehabilitation programmes, while 46% experienced difficulties related to motor coordination (e.g., breathing control and sustained contractions).
Interpretation of results
Pressure data showed distinguishable variations between rest and contraction phases in the posterior sensor, supporting the device’s ability to capture pelvic floor muscle activation, whereas anterior measurements appeared less consistent and more variable. The integration of a non-invasive external biofeedback device within an established mHealth platform appears feasible and highly acceptable in people with PD. Despite a high symptom burden and limited baseline awareness, participants engaged effectively with the intervention, reporting high satisfaction, no discomfort, and willingness to continue treatment. Barriers were primarily related to motor coordination, supporting device’s usability and potential to overcome limitations of invasive biofeedback.