METHODS: A retrospective non-inferiority study of patients at two academic tertiary referral centers who underwent radical hysterectomy between January 2010 and January 2020 was carried out. Patients were stratified according to timing of postoperative TOV: either pre-discharge or post-discharge from the hospital. Short-term urinary outcomes (including passing TOV, representation with retention) and long-term de novo urinary dysfunction (defined as irritative voiding symptoms, urgency, frequency, nocturia, stress or urgency incontinence, neurogenic bladder, and/or urinary retention) were extracted from the medical record. We hypothesized that the proportion of patients who failed pre-discharge TOV would be within a 15% non-inferiority margin of post-discharge TOV.
RESULTS: A total of 198 patients underwent radical hysterectomy for cervical (118 out of 198; 59.6%), uterine (36 out of 198; 18.2%), and ovarian (29 out of 198; 14.6%) cancer. One hundred and nineteen patients (119 out of 198, 60.1%) underwent pre-discharge TOV, of whom 14 out of 119 (11.8%) failed. Of the post-discharge TOV patients (79 out of 198, 39.9%), 5 out of 79 (6.3%) failed. The proportion of patients who failed a pre-discharge TOV was within the non-inferiority margin (5.4% difference, p = 0.23). A greater proportion of patients in the post-discharge TOV group developed long-term de novo urinary dysfunction (27.2% difference, p = 0.005). Median time to diagnosis of de novo urinary dysfunction was 0.5 years (range 0-9) in the pre-discharge TOV group versus 1.0 year (range 0-6) in the post-discharge TOV group (p > 0.05).
CONCLUSIONS: In this study, pre-discharge TOV had non-inferior short-term outcomes and improved long-term outcomes.
方法:对2010年1月至2020年1月在两个学术三级转诊中心接受根治性子宫切除术的患者进行了一项回顾性非劣效性研究。根据术后TOV的时间对患者进行分层:出院前或出院后。短期泌尿结果(包括通过TOV,保留表示)和长期从头泌尿功能障碍(定义为刺激性排尿症状,紧迫性,频率,夜尿症,压力或急迫性尿失禁,神经源性膀胱,和/或尿retention留)从病历中提取。我们假设出院前TOV失败的患者比例在出院后TOV的15%非劣效性范围内。
结果:总共198例患者接受了子宫颈根治性子宫切除术(198例中有118例;59.6%),子宫(198人中有36人;18.2%),和卵巢癌(198人中有29人;14.6%)。119名患者(198人中有119名,占60.1%)接受了出院前TOV,其中119人中有14人(11.8%)失败。出院后TOV患者(198人中有79人,占39.9%),79人中有5人(6.3%)失败。出院前TOV失败的患者比例在非劣效性范围内(差异为5.4%,p=0.23)。出院后TOV组出现长期从头排尿功能障碍的患者比例更高(差异为27.2%,p=0.005)。出院前TOV组诊断新尿路功能障碍的中位时间为0.5年(范围0-9),而出院后TOV组为1.0年(范围0-6)(p>0.05)。
结论:在这项研究中,出院前TOV的短期结局不差,长期结局改善.