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Defining success after surgical treatment of stress urinary incontinence
American Journal of Obstetrics and Gynecology ( IF 9.8 ) Pub Date : 2024-03-23 , DOI: 10.1016/j.ajog.2024.03.034
Rubin Raju , Annetta M. Madsen , Brian J. Linder , John A. Occhino , John B. Gebhart , Michaela E. McGree , Amy L. Weaver , Emanuel C. Trabuco

A consensus standardized definition of success after stress urinary incontinence surgical treatment is lacking, which precludes comparisons between studies and affects patient counseling. This study aimed to identify optimal patient-centric definition(s) of success after stress urinary incontinence surgical treatment and to compare the identified “” treatment success definitions with a commonly used (ie, no reported urine leakage, negative cough stress test result, and no retreatment). We evaluated 51 distinct treatment success definitions for participants enrolled in a previously conducted randomized trial of stress urinary incontinence treatments concomitantly performed with sacrocolpopexy (NCT00934999). For each treatment success definition, we calculated the mean (SD) of and scores with an 11-point Likert scale among those achieving success and failure. The “more accurate” treatment success definition(s) were identified by measuring the magnitude of the mean difference of participant assessments with Hedges values. The treatment success definitions with the highest Hedges values were considered “more accurate” treatment success definitions and were then compared with the composite definition of success. The percentage of participants who had treatment success (6.4% to 97.3%) and Hedges values (−4.85 to 1.25) varied greatly according to each treatment success definition. An International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form score ≤5, Urogenital Distress Inventory-6 score ≤33.3, and a no/mild stress urinary incontinence response on Urogenital Distress Inventory-6 question 3 had the highest Hedges values and were considered the top 3 “more accurate” treatment success definitions. Paradoxically, treatment success definitions that required a negative cough stress test result or no persistent urinary leakage greatly reduced the ability to differentiate between participant-assessed symptom improvement and surgical success. When the “more accurate” treatment success definitions were compared with the composite definition, patients with failed treatment according to the composite definition had lower Urinary Impact Questionnaire-7 scores and a higher proportion of survey responses indicating complete satisfaction or some level of satisfaction and very good/perfect bladder condition. In addition, the composite definition had considerably fewer favorable outcomes for participants than did the top 3 “more accurate” treatment success definitions. Successful outcomes of stress urinary incontinence surgical treatments for women undergoing concurrent sacrocolpopexy varied greatly depending on the definition used. However, stringent definitions (requiring complete dryness) and objective testing (negative cough stress test result) had decreased, rather than increased, participant-assessed symptom improvement and surgical success scores. The “more accurate” treatment success definitions better differentiated between participant-assessed symptom improvement and surgical success than the composite definition. The composite definition disproportionately misidentified participants who reported minor symptoms or complete/partial satisfaction with their outcome as having treatment failures and yielded a considerably lower proportion of women who reported favorable outcomes than did the top 3 “more accurate” treatment success definitions.

中文翻译:

压力性尿失禁手术治疗成功的定义

对于压力性尿失禁手术治疗后的成功缺乏统一的标准化定义,这妨碍了研究之间的比较并影响了患者咨询。本研究旨在确定压力性尿失禁手术治疗后以患者为中心的最佳成功定义,并将确定的“治疗成功定义”与常用的定义(即没有报告漏尿、咳嗽压力测试结果呈阴性以及不予再治疗)。我们对先前进行的一项压力性尿失禁治疗与骶骨阴道固定术同时进行的随机试验(NCT00934999)的参与者进行了 51 种不同的治疗成功定义的评估。对于每个治疗成功的定义,我们计算了成功和失败患者的平均值 (SD) 和 11 点李克特量表分数。通过测量参与者评估与对冲值的平均差异大小来确定“更准确”的治疗成功定义。具有最高对冲值的治疗成功定义被认为是“更准确”的治疗成功定义,然后与成功的复合定义进行比较。根据每种治疗成功的定义,治疗成功的参与者百分比(6.4% 至 97.3%)和 Hedges 值(−4.85 至 1.25)差异很大。国际尿失禁咨询问卷 - 尿失禁简表评分≤5,泌尿生殖窘迫量表 6 评分≤33.3,以及泌尿生殖窘迫量表 6 问题 3 的无/轻度压力性尿失禁反应具有最高的 Hedges 值,被认为是前 3 个“更准确”的治疗成功定义。矛盾的是,治疗成功的定义需要阴性咳嗽压力测试结果或没有持续性尿漏,这大大降低了区分参与者评估的症状改善和手术成功的能力。当将“更准确”的治疗成功定义与综合定义进行比较时,根据综合定义,治疗失败的患者具有较低的排尿影响问卷 7 分数,并且较高比例的调查答复表明完全满意或某种程度的满意,并且非常满意。膀胱状况良好/完美。此外,与前 3 个“更准确”的治疗成功定义相比,综合定义对参与者的有利结果要少得多。对于同时接受骶骨阴道固定术的女性来说,压力性尿失禁手术治疗的成功结果因所使用的定义而异。然而,严格的定义(要求完全干燥)和客观测试(阴性咳嗽压力测试结果)降低了参与者评估的症状改善和手术成功分数,而不是增加了分数。“更准确”的治疗成功定义比综合定义更好地区分参与者评估的症状改善和手术成功。综合定义不成比例地错误地将报告轻微症状或对其结果完全/部分满意的参与者视为治疗失败,并且与前 3 个“更准确”的治疗成功定义相比,报告良好结果的女性比例要低得多。
更新日期:2024-03-23
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