Supplementary Material for: Comparing single-incision midurethral sling with bulking agents for female stress urinary incontinence: rationale for a non-randomised controled trial

Objectives: Midurethral slings are considered the gold standard for the surgical treatment of stress-urinary incontinence (SUI), with an efficacy up to 80%. Another therapeutic option is the use of bulking agents, which create an artificial mass into the urethral submucosa, with an efficacy varying from 64% to 74%. Although bulking agents have a lower risk of complications than midurethral sling surgery, they are mainly used in case a midurethral sling is not an option or if midurethral sling surgery failed to cure stress urinary incontinence. In this study we offer all patients with SUI in secondary care a choice between a single incision midurethral sling procedure and treatment with a bulking agent. We want to examine patient preference and patient satisfaction for both procedures. We expect that offering both interventions in combination with standardized counselling will result in high patient satisfaction. Design: In this non-randomized controlled trial 266 patients will be objectively counselled for both interventions, after which all patients will choose between single-incision midurethral slings (SIMS) and Polyacrylamide hydrogel (PAHG), followed by the standard care procedure for women with SUI. Participants/Materials, Setting, Methods: From 1 January 2021 onwards, all consecutive adult patients (between 18 and 80 years of age) attending the outpatient gynaecology department with objectively confirmed, moderate to severe SUI will be eligible for enrolment in this non-randomized study. The primary outcome is patient satisfaction at 1 year, measured by the Patient Global Impression of Improvement; secondary outcomes are patient satisfaction at 3 months, objective and subjective cure at 3 months and 1 year, adverse events, postoperative pain and cost-effectiveness. Differences in outcome measures will be assessed through logistic and linear regression analyses, both unadjusted and adjusted with covariate adjustment using the propensity score. Results: No results are available yet. Limitations: The major disadvantage of this study design is the potential confounding bias. We intend to eliminate this bias by applying propensity scoring. Conclusion: By designing a non-randomized patient preference trial, we not only expect to demonstrate high patient satisfaction with both interventions, but also provide insight in the possible role of PAHG-injections in the treatment of female SUI as a first-choice non-conservative treatment. Trial Registration: This study is retrospectively registered at the Dutch Trial Registry on 22-03-2021 under the number NL9353.

研究目的：尿道中段悬吊术（midurethral slings）被视为压力性尿失禁（stress urinary incontinence, SUI）外科治疗的金标准，其疗效可达80%。另一治疗方案为填充剂（bulking agents），即向尿道黏膜下层注射以形成人工占位，疗效介于64%至74%之间。尽管填充剂的并发症风险低于尿道中段悬吊术，但仅在尿道中段悬吊术不可行或手术未能治愈压力性尿失禁时，方作为主要治疗手段。本研究为二级医疗保健机构中所有压力性尿失禁患者提供单切口尿道中段悬吊术与填充剂治疗的选择，旨在探究两种术式的患者偏好与满意度。我们推测，将两种干预手段与标准化咨询相结合，可获得较高的患者满意度。
研究设计：本项非随机对照试验将对266例患者就两种干预方案开展标准化咨询，随后由所有患者自主选择单切口尿道中段悬吊术（single-incision midurethral slings, SIMS）或聚丙烯酰胺水凝胶（polyacrylamide hydrogel, PAHG）治疗，后续按照压力性尿失禁女性的标准诊疗流程实施干预。
研究对象、材料、研究场景与方法：自2021年1月1日起，所有连续就诊于妇科门诊、经客观检查确诊为中重度压力性尿失禁的成年患者（年龄18~80岁）均可纳入本项非随机研究。本研究的主要结局为术后1年的患者满意度，采用患者总体印象改善评分（Patient Global Impression of Improvement）进行评估；次要结局包括术后3个月的患者满意度、术后3个月与1年的客观与主观治愈率、不良事件、术后疼痛及成本效益。结局指标的差异将通过logistic回归与线性回归分析进行评估，同时包含未校正与采用倾向得分进行协变量校正的分析。
研究结果：目前暂无相关研究结果。
研究局限性：本研究设计的主要缺陷为潜在的混杂偏倚，我们拟通过倾向得分法消除该偏倚。
研究结论：通过开展此项非随机化患者偏好试验，我们不仅有望证实两种干预手段均可获得较高的患者满意度，还可明确聚丙烯酰胺水凝胶注射作为女性压力性尿失禁首选非保守治疗手段的潜在应用价值。
试验注册：本研究于2021年3月22日在荷兰试验注册中心进行回顾性注册，注册编号为NL9353。