Solomon Michael J, Pager Chet K, Rex Jenny, Roberts Rachael, Manning Jane
Central Sydney Area Department of Colorectal Surgery at Royal Prince Alfred Hospital, Australia.
Dis Colon Rectum. 2003 Jun;46(6):703-10. doi: 10.1007/s10350-004-6643-9.
A prospective, three-armed, randomized, controlled trial was performed to assess whether pelvic floor exercises with biofeedback using anal manometry or transanal ultrasound are superior to pelvic floor exercises with feedback from digital examination alone in terms of continence, quality of life, physiologic sphincter strength, and compliance. Its secondary objectives were to assess whether there are any differences in these outcomes between biofeedback with transanal ultrasound vs. anal manometry and to correlate the physiologic measures with clinical outcome.
One hundred twenty patients with mild to moderate fecal incontinence were randomized into one of three treatment groups: biofeedback with anal manometry, biofeedback with transanal ultrasound, or pelvic floor exercises with feedback from digital examination alone. Commencing one week after an initial 45-minute assessment session, patients attended monthly treatments for a total of five sessions. Each session lasted 30 minutes and involved sphincter exercises with biofeedback that involved instrumentation or digital examination alone, and patients were encouraged to perform identical exercises twice per day between outpatient visits.
One hundred two patients (85 percent) completed the four-month treatment program. Across all treatment allocations, patients experienced modest but highly significant improvements in all nine outcome measures during treatment, with 70 percent of all patients perceiving improvement in symptom severity and 69 percent of patients reporting improved quality of life. With the possible exception of isotonic fatigue time, there were no significant differences between the three treatment groups in compliance, physiologic sphincter strength, and clinical or quality-of-life measures. Correlations between physiologic measures and clinical outcomes were much stronger with ultrasound-based measures than with manometry.
Although patients in this study who completed pelvic floor exercises with feedback from digital examination achieved no additional benefit from biofeedback and measurement with transanal ultrasound or manometry, it may be that the guidance received through digital examination alone offered patients in the pelvic floor exercise group an effective biofeedback mechanism. Contrary to our hypothesis, the use of transanal ultrasound offered no benefit over manometry, but the use of ultrasound for isotonic fatigue time and isometric fatigue contractions provided potentially important physiologic measures that require further study. This study has confirmed, through a large sample of patients, that pelvic floor retraining programs are an effective treatment for improving physiologic, clinical, and quality-of-life parameters in the short term.
开展了一项前瞻性、三臂、随机对照试验，以评估使用肛门测压法或经肛门超声进行生物反馈的盆底肌锻炼在控便能力、生活质量、生理性括约肌强度和依从性方面是否优于仅通过指诊反馈进行的盆底肌锻炼。其次要目标是评估经肛门超声生物反馈与肛门测压法在这些结果上是否存在差异，并将生理指标与临床结果相关联。
120例轻度至中度大便失禁患者被随机分为三个治疗组之一：肛门测压法生物反馈组、经肛门超声生物反馈组或仅通过指诊反馈进行的盆底肌锻炼组。在最初45分钟的评估 session 一周后开始，患者每月接受一次治疗，共五次。每次 session 持续30分钟，包括使用生物反馈的括约肌锻炼，该锻炼仅涉及器械检查或指诊，并且鼓励患者在门诊就诊期间每天进行两次相同的锻炼。
102例患者（85%）完成了为期四个月的治疗方案。在所有治疗分配中，患者在治疗期间所有九项结果指标上均有适度但高度显著的改善，70%的患者感觉症状严重程度有所改善，69%的患者报告生活质量有所提高。除等张疲劳时间外，三个治疗组在依从性、生理性括约肌强度以及临床或生活质量指标方面无显著差异。基于超声的测量方法在生理指标与临床结果之间的相关性比测压法更强。
尽管本研究中完成仅通过指诊反馈进行盆底肌锻炼的患者未从经肛门超声或测压法的生物反馈和测量中获得额外益处，但可能是仅通过指诊获得的指导为盆底肌锻炼组的患者提供了一种有效的生物反馈机制。与我们的假设相反，经肛门超声的使用并未比测压法更具优势，但超声用于等张疲劳时间和等长疲劳收缩提供了可能需要进一步研究的潜在重要生理指标。本研究通过大量患者样本证实，盆底肌再训练方案是短期内改善生理、临床和生活质量参数的有效治疗方法。
