Endometrial cancer is the fifth most incident cancer affecting women worldwide.[1] This cancer is treated primarily by surgical ablation of the uterus and appendices, while radiation therapy is the most frequently recommended adjuvant treatment. Urinary incontinence (UI) is reported by 30 to 80% of endometrial cancer survivors following these treatments. While pelvic floor muscle training (PFMT) and bladder training (BT) are two recommended first-line treatments for UI in women without a history of cancer, the benefits of these approaches for endometrial cancer survivors remain uncertain. Considering that challenges in access to healthcare are growing, mobile technologies may be a viable option to deliver rehabilitation interventions.[2] This study is the first to investigate the effects of an in-home rehabilitation program, including the use of the Elvie Trainer mobile technology, in women with UI who have been treated for endometrial cancer. Our main hypothesis was that at least 50% of participants would demonstrate improvements in their UI severity by the end of the program.

To assess the process of change at an individual level, a single-case A1-B-A2 experimental study with replications was conducted. Participants were included if they 1) had been diagnosed with endometrial cancer stage I, 2) had been treated with total hysterectomy and brachytherapy at least 12 months ago, 3) were continent prior to the cancer treatments, and 4) presented with de novo UI which occurred at least 3x/week based on self-report. Women were not eligible to participate if they presented with prolapse (POPQ>stage 2), urinary or vaginal infection at medical follow-up, severe vaginal stenosis, concomitant cancer, any other adjuvant cancer treatment (including external-beam radiation therapy), or any physical impairments limiting participation in the tests planned for this study.  All participants provided written informed consent prior to enrolling in the study. The B-phase (intervention) included daily PFMT performed using the Elvie Trainer for a 12-week duration. The Elvie Trainer (Chiaro Technology Limited, United Kingdom) is a commercially available intra-vaginal device which connects to a mobile phone or tablet via Bluetooth technology to provide real-time biofeedback on contraction force generated during PFMT. BT was provided concurrently through weekly telephone follow-up by a physiotherapist. Baseline (A1) and final (A2) assessments were each conducted over a 2-week period before and after the B-phase. The main outcome measure for UI severity was the 1h-Pad Test; it was assessed 3 times during the A1- and A2-phases, and 5 times during the B-phase. Pelvic floor muscle (PFM) morphology and functional properties were assessed using ultrasound and dynamometry, and secondary measures of UI severity including a 3-day bladder diary and the ICIQ-UI SF questionnaire were also collected but are not reported in the present abstract. Descriptive analyses were first conducted for the whole sample and, following recommendations from Lane and Gast [3], comparisons of UI severity between phases were conducted using graphical analysis for each individual: changes of absolute and relative levels, of direction and stability of the trend curves, and the 95% confidence interval (95%CI) of the A1- and A2-phases (see Table 1 for details) were all evaluated.

Eight participants were recruited between July 2018 and July 2019. Participants were aged between 39 and 76 years old (mean 66.1 ± 12.5 years), had Body Mass Indices between 23 and 54.6 kg/m2 (mean 30.7 ± 8.8 kg/m2). They reported between 3 and 18 episodes of urinary urgency and urinary incontinence in the 3-day bladder diary prior to beginning the study. Three participants reported that their level of comfort and autonomy with technology was “excellent”, while it was characterized as “poor” for 3 others, and “moderate” for 2 participants. The results of the 1h-Pad Tests at the various follow-up evaluations are presented in Figure 1 for the 8 participants. Three participants had higher UI severity (greater leaks during the 1hr-Pad Tests) at the beginning of the study (A1-phase) that resolved during the intervention phase (B). The median [range] of leakages in grams measured by the 1h-Pad Tests for each participant (S1 to S8) throughout the study were: S1: 0.10 [0.00 - 2.96], S2: 0.63 [0.10 - 6.96], S3: 0.59 [0.00 - 6.66], S4: 2.38[0.00 - 56.39], S5: 0.46 [0.03 - 1.86], S6: 0.35 [0.06 - 5.17], S7: 2.91 [0.39 - 33.10] and S8: 2.50 [0.22 - 33.85]. 

For the between-phase analyses, changes were classified as positive (reduced leakage) or negative (increased leakage) as can be seen in Table 1. Most women (7/8) had a positive change in UI severity according to changes in absolute (6/8) and relative levels (7/8), and in the direction (5/7) or stability (5/7) of their trend curves, and baseline data were outside (over) the final 95%CI for 5 of the 8 women demonstrating an improvement in UI severity after the intervention.

Our main hypothesis was verified with more than 50% of participants presenting with improvement in UI severity after the in-home rehabilitation program. Indeed, UI severity was found improved in 87.5% of the participants for at least one graphical analysis during the B- and/or A2-phases of the program. The interpretation of these results may be further clarified by the analysis of the effects of in-home rehabilitation on PFM morphology and functional properties collected as secondary outcomes in this study.

This study is the first time that changes in UI severity are reported after an in-home rehabilitation program, including the use of the Elvie Trainer and remote BT education, in survivors of endometrial cancer. The results of this program on urinary leakage measured with the 1h-Pad Test are encouraging. Further analysis of secondary outcomes and of the characteristics of the respondents is needed before recommending in-home rehabilitation using mobile technologies to improve UI severity in survivors of endometrial cancer.

Bray, F., Ferlay, J., Soerjomataram, I., Siegel, R. L., Torre, L. A., & Jemal, A. (2018). Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians, 68(6), 394-424.
Bernard, S., Boucher, S., McLean, L., & Moffet, H. (2019). Mobile technologies for the conservative self-management of urinary incontinence: a systematic scoping review. Int Urogynecol J. doi:10.1007/s00192-019-04012-w
Lane, J.D. and D.L. Gast, Visual analysis in single case experimental design studies: brief review and guidelines. Neuropsychol Rehabil, 2014. 24(3-4): p. 445-63.