Lo Tsia-Shu, Harun Fazlin, Chua Sandy, Shen Yu-Hua, Tan Yiap Loong, Hsieh Wu-Chiao
Division of Urogynecology, Department of Obstetrics and Gynecology, Linkou, Chang Gung Memorial Hospital, Linkou Medical Center, Taoyuan, Taiwan, ROC; Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Keelung Medical Center, Keelung, Taiwan, ROC; Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Taipei, Medical Center, Taipei, Taiwan, ROC; Chang Gung University, School of Medicine, Taoyuan, Taiwan, ROC.
Department of Obstetrics and Gynecology, Women and Children Hospital (Hospital Tunku Azizah), Kuala Lumpur, Malaysia.
J Formos Med Assoc. 2024 Mar;123(3):331-339. doi: 10.1016/j.jfma.2023.11.003. Epub 2023 Nov 22.
We present this current study to complement with mesh inlays plausible benefits (UPHOLD-LITE System) on available long-term study amidst FDA's concern on mesh complications. This study aims to assess the medium-term outcomes of UPHOLD-LITE system for treatment of advanced pelvic organ prolapse (POP) and its complications, and lower urinary tract symptoms.
This is a retrospective case series of 53 months follow-up of 123 consecutive patients who underwent UPHOLD-LITE system. Objective outcome measures the anatomical correction of prolapse with POP-Q ≤ Stage 1. Subjective outcome was patient's feedback to questions 2 and 3 of POPDI-6. Secondary outcome measures the quality of life, presence of lower urinary tract symptoms and complications. Quality of life is assessed by validated questionnaires on Urogenital Distress Inventory 6 (UDI-6), Incontinence Impact Questionnaire 7 (IIQ-7), Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6), and Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire 12 (PISQ-12) at 1 and 3 years post-operatively.
Objective outcome at 1 and 3 years was at 96.7 % and 95.4 % respectively. The subjective cure was 95.1 % and 91.6 %. Five-year cumulative cure rate maintained at 87.2 %. Secondary outcomes observed improvement on UDI-6, IIQ-7, POPDI-6 and PISQ-12 postoperatively. Bladder outlet obstruction improved while de novo urodynamic stress incontinence (USI) increased slightly post surgically. Mesh erosion rate was 0.8 %.
The UPHOLD-LITE system demonstrated good medium term anatomical correction of apical and anterior prolapse, with good subjective cure and improved quality of life. Whilst complication rate was low, slight increase in de novo USI was observed.
鉴于美国食品药品监督管理局（FDA）对网片并发症的关注，我们开展本项研究，以补充关于网片嵌体（UPHOLD-LITE系统）潜在益处的现有长期研究。本研究旨在评估UPHOLD-LITE系统治疗重度盆腔器官脱垂（POP）及其并发症和下尿路症状的中期疗效。
这是一项回顾性病例系列研究，对123例连续接受UPHOLD-LITE系统治疗的患者进行了53个月的随访。客观结局指标为采用盆腔器官脱垂定量分期系统（POP-Q）评估脱垂解剖复位至≤1期。主观结局为患者对盆腔器官脱垂症状指数-6（POPDI-6）中问题2和问题3的反馈。次要结局指标为生活质量、下尿路症状及并发症的存在情况。生活质量通过术后1年和3年使用经过验证的泌尿生殖系统困扰量表6（UDI-6）、尿失禁影响问卷7（IIQ-7）、盆腔器官脱垂困扰量表6（POPDI-6）以及盆腔器官脱垂/尿失禁性功能问卷12（PISQ-12）进行评估。
1年和3年时的客观治愈率分别为96.7%和95.4%。主观治愈率分别为95.1%和91.6%。5年累积治愈率维持在87.2%。次要结局显示术后UDI-6、IIQ-7、POPDI-6和PISQ-12均有改善。膀胱出口梗阻有所改善，而术后新发尿动力学压力性尿失禁（USI）略有增加。网片侵蚀率为0.8%。
UPHOLD-LITE系统在中期对顶端和前部脱垂显示出良好的解剖复位效果，主观治愈率良好，生活质量得到改善。虽然并发症发生率较低，但观察到新发USI略有增加。
