School of Medicine, Western Sydney University, Campbelltown, New South Wales, Australia.
School of Computer, Data and Mathematical Sciences, Western Sydney University, Parramatta, New South Wales, Australia.
PLoS One. 2024 Sep 27;19(9):e0311134. doi: 10.1371/journal.pone.0311134. eCollection 2024.
Biofeedback therapy is useful for treatment of functional defecation disorders but is not widely available and is labor intensive. We developed an Internet-of-Medical-Things (IoMT) device, enabling self-guided biofeedback therapy. This study assesses the safety and efficacy of self-guided biofeedback therapy using the IoMT device in comparison to standard operator-led therapy. Patients experiencing urge or seepage fecal incontinence (≥1 episode/week) were randomly assigned to either our IoMT system or to the conventional anorectal manometry-based therapy. Both interventions comprised six weekly sessions, focusing on enhancing anal strength, endurance, and coordination. The novel device facilitated self-guided therapy via visual instructions on a companion app. Primary outcomes included safety/tolerability, changes in Vaizey severity scores, and alterations in anorectal pressure profiles. Twenty-five patients (22 females, 3 males) participated, with 13 in the novel device group and 12 in the standard therapy group. Both groups showed significant reductions in symptom severity scores: IoMT device group -4.2 (95% CI: -4.06, -4.34, p = 0.018), and the standard therapy group -4.8 (95% CI: -4.31, -5.29, p = 0.028). Anal sphincter resting pressure and sustained squeeze time improved significantly in both groups, and the novel device group demonstrated an increase in maximum sphincter squeeze pressure. There were no significant differences between the therapy groups. Importantly, the experimental device was well-tolerated compared with standard therapy, with no serious adverse events observed. This study demonstrates the comparable efficacy of self-administered biofeedback using the IoMT device with traditional biofeedback therapy. The results demonstrates the potential of the IoMT device as a safe, self-guided method for FI therapy, offering convenience and effectiveness in fecal incontinence management.
生物反馈疗法对功能性排便障碍的治疗有效，但尚未广泛应用，且劳动强度大。我们开发了一种医疗物联网 (IoMT) 设备，实现了自我引导的生物反馈治疗。本研究评估了使用 IoMT 设备进行自我引导的生物反馈治疗的安全性和疗效，并与标准操作员引导的治疗进行了比较。患有急迫或渗漏性粪便失禁（≥1 次/周）的患者被随机分配到我们的 IoMT 系统或传统的基于肛门直肠测压的治疗组。两种干预措施均包括每周 6 次治疗，重点是增强肛门力量、耐力和协调性。新型设备通过配套应用程序上的视觉指导促进自我引导治疗。主要结局包括安全性/耐受性、Vaizey 严重程度评分的变化以及肛门直肠压力谱的改变。25 名患者（22 名女性，3 名男性）参与了研究，其中 13 名患者在新型设备组，12 名患者在标准治疗组。两组患者的症状严重程度评分均显著降低：IoMT 设备组-4.2（95%CI：-4.06，-4.34，p=0.018），标准治疗组-4.8（95%CI：-4.31，-5.29，p=0.028）。两组患者的肛门括约肌静息压和持续收缩时间均显著改善，新型设备组的最大括约肌收缩压也有所增加。两组治疗之间无显著差异。重要的是，与标准治疗相比，实验设备具有更好的耐受性，未观察到严重不良事件。本研究表明，使用 IoMT 设备进行自我管理的生物反馈与传统生物反馈治疗具有相当的疗效。研究结果表明，IoMT 设备作为一种安全、自我引导的 FI 治疗方法具有潜力，为粪便失禁管理提供了便利和有效性。
