Division of Urogynecology, Department of Obstetrics and Gynecology, Linkou, Chang Gung Memorial Hospital, Linkou Medical Center, Taoyuan, Taiwan; Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Keelung Medical Center, Keelung, Taiwan; Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Taipei, Medical Center, Taipei, Taiwan; Chang Gung University, School of Medicine, Taoyuan, Taiwan.
Department of Obstetrics and Gynecology, Women and Children Hospital (Hospital Tunku Azizah), Kuala Lumpur, Malaysia.
Taiwan J Obstet Gynecol. 2024 Sep;63(5):685-691. doi: 10.1016/j.tjog.2024.03.020.
To evaluate the surgical outcomes and predictors of failure of Single Incision Mini Sling (Ophira) in women with urodynamic stress incontinence.
Records of 115 women underwent anti-incontinence procedure using Ophira Mini Sling from June 2019 to September 2020 reviewed. Subjective evaluation was assessed using validated IIQ-7, UDI-6, POPDI-6 and PISQ-12 questionnaires. Multichannel urodynamics, 1-h pad test and 72-h voiding diary was performed as objective evaluation. Primary outcome was the objective cure rate of negative urine leak on provocative filling cystometry and 1-h pad test weight <2 g, and subjective cure rate was negative response to question 3 of UDI-6. Secondary outcome was to identify risk factors associated with failure for Ophira.
Total of 108 women were evaluated. The objective cure rate was 91.7% with subjective cure rate of 86.1%. Comparison of clinical outcome shows significant improvement of USI post-operatively (p < 0.001) and reflected in 1-h pad test (p < 0.001). Improvement in all subjective evaluation parameters is seen except for POPDI-6. Failure of Ophira correlate significantly in women age >66 years, presence of asthma, pre-operative Intrinsic Sphincter Deficiency (ISD), and Maximum Urethral Closure Pressure (MUCP) value < 40 cmH20.
Ophira Single Incision Mini Sling is safe and effective treatment option for USI, showing high objective and subjective cure rates with low incidence of complications. Non-modifiable risks of age ≥66 years, asthma status, pre-operative intrinsic sphincteric deficiency and low maximal urethral closure pressure were the factors of failure for Ophira.
评估单切口迷你吊带（Ophira）治疗女性压力性尿失禁的手术效果和失败预测因素。
回顾 2019 年 6 月至 2020 年 9 月期间 115 例接受 Ophira 迷你吊带抗失禁手术的女性患者的记录。使用经过验证的 IIQ-7、UDI-6、POPDI-6 和 PISQ-12 问卷进行主观评估。多通道尿动力学检查、1 小时垫试验和 72 小时排尿日记作为客观评估。主要结果是在诱发充盈性膀胱测压和 1 小时垫试验重量<2g 时尿漏的阴性客观治愈率，以及 UDI-6 第 3 个问题的阴性反应率。次要结果是确定与 Ophira 失败相关的风险因素。
共 108 例女性患者接受了评估。客观治愈率为 91.7%，主观治愈率为 86.1%。术后尿失禁（USI）的临床结果比较显示显著改善（p<0.001），并反映在 1 小时垫试验中（p<0.001）。除了 POPDI-6 外，所有主观评估参数均有改善。Ophira 失败与女性年龄>66 岁、存在哮喘、术前固有括约肌缺陷（ISD）和最大尿道闭合压（MUCP）值<40cmH20 显著相关。
Ophira 单切口迷你吊带是治疗 USI 的安全有效方法，具有较高的客观和主观治愈率，并发症发生率低。不可改变的危险因素为年龄≥66 岁、哮喘状态、术前固有括约肌缺陷和最大尿道闭合压低，是 Ophira 失败的因素。
