Hypothesis / aims of study
Pelvic floor muscle (PFM) training is suggested to be the first line conservative therapy for stress urinary incontinence (SUI), the most prevalent urinary incontinence subtype [1], comprising intensive, supervised exercise programs of at least three months’ duration [2]. Recently, telerehabilitation for PFM training has emerged as a promising approach for enhancing patient motivation and adherence [3], yet its effectiveness as an alternative to the ‘gold standard’ face-to-face (FtF) approach remains largely unexplored, especially within the Greek healthcare setting. Thus, this study aims to evaluate the effectiveness of a telerehabilitation PFM training program compared to the traditional FtF; hypothesizing the telerehabilitation program would be equally effective.
Study design, materials and methods
This three-arm randomized controlled trial invited adult women with an SUI diagnosis, able to read/write in Greek, familiar with teleconferencing applications and smart devices and capable of voluntarily contracting their PFM during initial clinical examination. Women less than six months postpartum, suffering from systemic diseases, malignancy, neurological disorders, mental impairment or having had major gynecological surgery (last 10 years) were excluded. Following informed consent, group randomization was performed through a pre-generated computer-list utilizing blocks of six with allocation concealed in sealed envelopes. All participants initially received a thorough FtF assessment by a pelvic floor physiotherapist, where a comprehensive advisory leaflet was provided, along with a standardized 12-week, individually prescribed progressive PFM training program (3x/week). The experimental group received a blended intervention combining synchronous (weekly supervised via online platform) and asynchronous (educational video-based, accessible anytime) components. The FtF group performed the program under continuous therapist supervision (outpatient healthcare setting). The control group (CG) was encouraged to continue the exercises shown in initial assessment (unsupervised). Although participants and therapists could not be blinded, outcome assessors and data analyst were blinded to group allocation. An intention-to-treat analysis was used. Outcomes (tested at baseline and 12-weeks) included the “1-hour Pad test” measuring urine leakage and the Greek-validated Australian Pelvic Floor Questionnaire (APFQ_Greek). Repeated measures ANOVA were utilized for pre- to post-intervention group differences.
Results
Out of 60 initially enrolled SUI women as per power analysis calculations (GPower 3.1 for repeated measures within-between interaction, a=0.05, power=0.95, effect size=0.3 estimated a required sample of 48 participants plus 12 more, to account for a 20% potential dropout rate), 56 completed the trial, aged 54.5±12.7 years-old with body mass index of 27.2±5.6 (classified as overweight) and mean symptom duration of 111.5±132.1 months (≈ 9.3 years). Participants were randomly allocated to Telerehab (n=18), Traditional/FtF (n=19) and Control (n=19) groups. Non-statistically significant differences were yielded between groups across all baseline measurements. At 12 weeks, the 1-hour pad test yielded significant reductions in urine loss within groups (p=0.03), but not between groups (p=0.27). Mean baseline and 12-week post-intervention reports were: 3.82±3.47 and 3.63±9.73 (Telerehab), 4.29±3.89 and 1.64±2.47 (Traditional), and 5.79±5.16 and 2.73±4.14 (CG), respectively. Similarly, APFQ Greek total score as well as two of its subscales (Bladder and Bowel) yielded significant improvements in SUI severity within each group (p≤0.001) but not between them (p>0.05).
Interpretation of results
In this challenging SUI sample (high menopausal rates, long symptom duration, overweight) telerehabilitation proved effective, showing significant improvements in urinary leakage, incontinence severity, bladder- and bowel-related symptoms. Compared to gold standard FtF therapy, telerahabilitation was equally effective, suggesting a promising and effective treatment option for SUI. Active engagement of the CG (documented through the exercise diaries) and the initial individually tailored PFM program given could have accounted for this group’s significant symptom improvements.