Reducing Low Anterior Resection Syndrome After Low Rectal Cancer Surgery Using an Integrated Intra-Anal Balloon Training and Reminder Device: Feasibility Nonrandomized Controlled Trial

Background: Low anterior resection syndrome (LARS) is a common postoperative complication in patients with low rectal cancer, presenting with a spectrum of bowel dysfunction symptoms, including urgency, incontinence, evacuation disorders, and changes in stool frequency. Pelvic floor muscle training (PFMT) can alleviate LARS, but its effectiveness may be limited by poor accuracy of technique and low adherence during home-based training due to a lack of real-time feedback and monitoring devices. Objective: This study aimed to evaluate the effects of a novel integrated balloon biofeedback device for home-based PFMT on accuracy of technique, adherence, quality of life, and LARS reduction in patients after sphincter-preserving surgery for low rectal cancer. Methods: A nonrandomized controlled trial was conducted among 164 patients with low rectal cancer who underwent temporary ileostomy without neoadjuvant therapy. Participants were assigned by surgical date to an intervention group (n=82) using an adjustable-pressure balloon device with real-time waveform feedback via a mobile app or a control group (n=82) performing PFMT without equipment. PFMT was initiated within 72 hours after temporary ileostomy and continued throughout the stoma period until 1 month after ileostomy reversal. Outcomes including PFMT accuracy of technique, adherence, LARS score and incidence, and quality of life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30) were assessed 1 month after stoma reversal. Results: At baseline, major LARS was present in 47.6% (39/82) of patients in the intervention group and 62.2% (51/82) of patients in the control group. Compared with the control group, the intervention group showed significantly higher PFMT training accuracy and adherence (P<.001 in both cases). LARS scores were significantly lower in the intervention group (median 16.00, IQR 11.00-29.00 vs 32.00, IQR 13.75-36.00), with a markedly reduced proportion of major LARS (17/82, 20.7% vs 45/82, 54.9%; P<.001). Global health/quality of life scores were significantly higher in the intervention group (P<.001). Conclusions: The integrated balloon biofeedback device improved the accuracy of technique and adherence to home-based PFMT, reduced the incidence and severity of LARS, and enhanced quality of life in patients after low rectal cancer surgery. These findings support further development and clinical implementation of the device. However, the nonrandomized, time-sequenced study design and baseline differences between groups may limit causal interpretation of the results, and randomized controlled trials with longer follow-ups are needed to confirm long-term efficacy.