Hypothesis / aims of study
The primary aim was to evaluate the effectiveness of a telerehabilitation program on reports of urinary incontinence(UI) in women post- gynecological pelvic cancer(GPA) treatment. The secondary aims were to assess fecal incontinence(FI), vaginal stenosis(VS), sexual dysfunction, dyspareunia, self- physical activity(PA), the barriers and facilitators to adherence and treatment satisfaction.
Study design, materials and methods
A randomized controlled trial(RCT) with two arms, one that received the online intervention(IG) and a control group(CG) that followed the routine of the service.
The study included women over 18 years of age assisted in a reference service; clinical stage I to III of GPC; who had undergone surgery, radiotherapy and/or brachytherapy, self-reported UI; with no orthopedic or neurological impairments.
This study was approved by the Ethics Committee and registered in the Clinical Trials. The participants were recruited from a list of the institution.
The sample size calculation was based on the score of the ICIQ-SF pilot study using the G*Power software, indicating 29 participants in each group (alpha level of 0.05 and 80% power of the test). A computerized list of random numbers, was generated and the allocation of participants in the groups was concellead.
The IG participated in 12weeks telerehabilitation including PFMT[1]. The CG received the routine treatment of the institution including life style and PFMT instructions. Data was collected in two stages: pre-intervention and after 12weeks.
The primary outcome UI was measured using the ICIQ-SF. The secondary outcomes were measured using validated questionnaires and scales. Barriers and facilitators related to telereahabilitation were assessed only after 12 weeks using questionnaires. Satisfaction with the treatment was assessed using anumerical scale and adherence to PFMT at home was assessed using a diary.
A mixed-effects model was used to assess the effect of the intervention. Data analysis used an intention-to-treat analysis approach, 95% confidence intervals (95%CI) were calculated for the mean differences observed, within and between groups. The significance level adopted was α=0.05, and all analyzes were performed using the R software (Version 2024.04.1+748).
Results
Figure 1 shows the flow of participants in the study. A total of 59 participants were randomized into an IG n=29 (47±10,24 years), and a CG n=29 (48±10,32 years). The groups were homogeneous in relation to all variable (age, type of cancer treatment, cancer stage BMI, parity, type of birth) except UI severity that was more severe at baseline in the IG.
After 12 weeks of intervention, the IG showed a significantely lower prevalence of self-reported UI (OR 0.038, 95% 0.005 to 0.320), an improvement in the severity and impact of UI on QL (95% CI 4.45; 5.36), an improvement in dyspareunia (95% CI 3.88; 1.51) and in pelvic pain (95% CI 3.61;-0.11) compared to CG prevalence of self-reported UI (OR 0.964, 95% 0.898 to 1.03), the severity and impact of UI on QL (95% CI 9.97; 5.41), dyspareunia (95% CI 6.16; 2.50) and in pelvic pain (95% CI 4.28; 3.62).
No statistical diference was found in any other secondary outcomes of the study.
Of the 29 participants included in the intervention group, 20 (68.9%) adhered to 100% of the 12 scheduled supervised sessions. A total of 25 participants (80%) adhered to 3 home sessions per week.
As for the usability of the system, 65% defined the telerehabilitation as good. The participants' average satisfaction with the intervention was 9.5(VAS). There were no reports of adverse events with the training.
Interpretation of results
The 12 week telerehabilitation program investigated was effective in reducing UI reports, severity of UI, dyspareunia and pelvic pain in women post-GPC treatment.