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Are anterior mesh arms necessary in Japanese-style transvaginal mesh surgery for cystocele?
日本式阴道网格手术中前置网格臂是否必要？

Masaki Watanabe , Masami Takeyama , Tomoko Kuwata , Hiromi Kashihara ,
Masaki Watanabe ，Masami Takeyama ，Tomoko Kuwata ，Hiromi Kashihara ，Chikako Kato and Miho Hirota
卡藤千佳 和广田美穗 Urogynecology Center, First Towakai Hospital, Osaka, Japan
日本大阪第一东脇医院泌尿妇科中心 Arakawa Chemical Industries, Ltd., Osaka, Japan
日本大阪荒川化学工业株式会社

Abstract 摘要

Aim: In this study, we retrospectively analyzed the medium-term efficacy and safety of surgery with transobturator two-arm transvaginal mesh for cystocele and to verify whether the anterior arms are necessary for Japanese-style transvaginal mesh surgery. Methods: The study included 203 patients with cystocele who underwent transobturator two-arm transvaginal mesh at our hospital between August 2015 and June 2017 and received appropriate follow-up care for at least 48 months after surgery. Results: The Pelvic Organ Prolapse Quantification stage was III in all the patients. Intraoperative complications included two cases of bladder injury and one case of more than 200 mL of blood loss. The mean observation period was 51.9 months, and prolapse recurred in the operated compartment in nine patients ( . No cases of mesh exposure were observed. In comparing the preoperative characteristics of the 9 patients with prolapse recurrence at the surgical site with those of the other 194 patients, we found that the recurrence rate was significantly higher among patients in whom point Ba being 3.5 cm or more and among patients younger than 66 years. Conclusions: Transobturator two-arm transvaginal mesh for cystocele was as good and safe as the procedure previously reported with four-arm mesh; thus, it was possible to omit the anterior mesh arms in Japanese-style transvaginal mesh surgery. Patients should be informed preoperatively that prolapse recurs at a significantly higher rate among younger patients and in those whose point Ba being 3.5 cm or more.
目的：在本研究中，我们回顾性分析了经阴道两臂经阴道网格手术治疗膀胱脱垂的中期疗效和安全性，并验证了日本式经阴道网格手术是否需要前臂。 方法：研究包括 203 名患有膀胱脱垂的患者，他们在 2015 年 8 月至 2017 年 6 月间在我们医院接受了经阴道两臂经阴道网格手术，并在手术后至少 48 个月接受了适当的随访护理。 结果：所有患者的盆腔器官脱垂定量分期均为 III 期。术中并发症包括两例膀胱损伤和一例超过 200 毫升的出血。平均观察期为 51.9 个月，在 9 名患者（ ）中手术区域脱垂复发。未观察到网格外露的病例。将手术部位脱垂复发的 9 名患者的术前特征与其他 194 名患者进行比较，发现 Ba 点≥3.5 厘米和年龄小于 66 岁的患者中复发率显著较高。 结论：经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经阴道经

Key words: clinical outcomes, objective recurrence rates, pelvic organ prolapse, surgical complications, transvaginal mesh.
关键词：临床结果，客观复发率，盆腔器官脱垂，手术并发症，阴道网。

Introduction 介绍

Pelvic organ prolapse (POP) is common among middle-aged and elderly women and worsens quality of life. POP develops when tissues that support the pelvic floor, such as the sacrouterine ligament, pubocervical fascia, and arcus tendineus fascia pelvis, loosen or collapse as a result of aging, childbirth, and obesity. The ultimate treatment is surgical reconstruction of the pelvic floor. Native tissue repair without mesh has been carried out for many years, but POP recurs after surgery at a high rate. To compensate for the weakness, surgery with nonabsorbable synthetic transvaginal mesh (TVM) was introduced in the late 1990s.
盆腔器官脱垂（POP）在中年和老年妇女中很常见，会加重生活质量。 POP 发生在支撑盆底的组织，如子宫韧带、耻子宫筋膜和髂腱膜盆底，由于老化、分娩和肥胖而松弛或坍塌。 最终的治疗方法是盆底手术重建。多年来一直进行无网格的本体组织修复，但手术后 POP 复发率很高。为了弥补这种弱点，于 1990 年代末引入了使用不可吸收合成经阴道的网格（TVM）的手术。
Starting with Prolift mesh (Johnson & Johnson, New Brunswick, NJ, USA), whose use was standardized by the French TVM group, several mesh kits have been developed and widely used, mainly in Europe and the United States. However, TVM surgery
从 Prolift 网格（美国新不伦瑞克州约翰逊和约翰逊公司）开始，其使用已被法国 TVM 团队标准化，已开发并广泛使用了几种网格套件，主要在欧洲和美国。然而，TVM 手术
with polypropylene mesh was discontinued in the United States by the US Food and Drug Administration because of a high number of mesh-related complications and is no longer performed in most Western countries. In Japan, Prolift-type TVM surgery with self-cut polypropylene mesh was introduced in 2005 , has been uniquely developed and is a safe and efficient procedure still performed to treat POP, with few mesh-related complications.
在美国，由于与网格相关的并发症数量较高，聚丙烯网格手术已被美国食品和药物管理局停止使用，并且在大多数西方国家不再进行。 在日本，自行切割的聚丙烯网格的 Prolift 型 TVM 手术于 2005 年引入，已经得到独特发展 ，是一种安全高效的程序，仍然用于治疗盆腔器官脱垂，几乎没有与网格相关的并发症。
In Japanese-style TVM surgery, which is Prolifttype TVM surgery modified by Japanese surgeons, self-cut mesh is placed between the entire vaginal wall and the muscle layer of the urinary bladder with special needles necessary for the mesh arms to penetrate the firm tissue around the ischial spine (e.g., the site of adhesion of the sacrospinous ligament [SSL] to the ischial spine), the arcus tendinous fascia pelvis (in anterior TVM), and SSL (in posterior TVM). Unlike the procedures performed in Western countries, Japanese-style TVM surgery includes elaborate anchoring and extension of the mesh without wrinkles. The four important anchoring points are firm tissue around both sides of the ischial spine, the center of the distal vaginal wall, and the uterine cervix. The anterior mesh arms are designed to help the mesh expand only laterally; therefore, the anchoring of anterior mesh arms through the obturator foramen did not seem necessary. Broad paravesical dissection performed to insert the anterior mesh arms increases the risk for bladder injury, ureteral injury, blood loss, and voiding disorders. Therefore, omitting the anterior mesh arms and minimizing the range of paravesical dissection are desirable; in this way, the anchor with the remaining two posterior mesh arms plays a more important role in surgery. The most useful anchoring point is the firm tissue around the ischial spine, which the posterior mesh arms of the anterior TVM mesh penetrate. This anchoring procedure is so difficult that hands-on training and much experience are necessary to master it. We thought that the anterior mesh arms would not be necessary in Japanese-style TVM surgery, which involves this precise anchoring of the posterior mesh arms.
在日本式 TVM 手术中，由日本外科医生修改的 Prolift 型 TVM 手术，自行切割的网格被放置在整个阴道壁和膀胱肌层之间，需要用特殊针头穿透坚固组织以使网格臂穿过坐骨棘周围的组织（例如，骶棘韧带[SSL]与坐骨棘的粘附部位），髂筋膜盆底（在前置 TVM 中）和 SSL（在后置 TVM 中）。与西方国家进行的程序不同，日本式 TVM 手术包括精心的锚定和网格的延伸，避免皱褶。四个重要的锚定点是坐骨棘两侧的坚固组织、远端阴道壁的中心和子宫颈。前置网格臂设计为帮助网格仅侧向扩展；因此，通过闭孔肌孔锚定前置网格臂似乎并不必要。进行广泛的膀胱旁解剖以插入前置网格臂会增加膀胱损伤、输尿管损伤、失血和排尿障碍的风险。 因此，省略前部网格臂并最小化骨盆旁切除范围是可取的；这样，剩余的两个后部网格臂与锚点在手术中扮演更重要的角色。最有用的锚定点是坚固的坐骨棘周围组织，前置 TVM 网格的后部网格臂穿过这些组织。这种锚定程序非常困难，需要实际操作培训和丰富经验才能掌握。我们认为在日本式 TVM 手术中，前部网格臂是不必要的，因为这种手术涉及对后部网格臂进行精确锚定。
In the two-arm TVM procedure ("TVM-A2"), we add fixing threads at one place on each side to help the mesh expand laterally, instead of using the anterior mesh arms. To verify whether it is possible to omit the anterior mesh arms in Japanese-style TVM procedure, we investigated the medium-term surgical results retrospectively.
在双臂 TVM 程序（“TVM-A2”）中，我们在每侧的一个地方添加固定线来帮助网格横向扩展，而不是使用前置网格臂。为了验证在日本式 TVM 程序中是否可以省略前置网格臂，我们进行了中期手术结果的回顾性调查。

Methods 方法

We studied the records of 203 patients with cystocele who underwent TVM-A2 at our hospital between August 2015 and June 2017 and who received the appropriate follow-up care for at least 48 months after surgery. We used the Pelvic Organ Prolapse Quantification (POP-Q) system to assess patients' preoperative anatomical status, the Overactive Bladder Symptom Score (OABSS) to assess the subjective status of urine storage, and uroflowmetry and residual urine measurement to assess objective voiding function. Operative time, blood loss, concomitant surgery, and complications were assessed as well. Postoperative anatomical recurrence of prolapse and complications were evaluated 3 and 12 months after surgery and then annually thereafter, and objective voiding function was evaluated with uroflowmetry and residual urine measurement 3 months after surgery. Anatomical recurrence of prolapse was defined as POP-Q stage II or higher. Preoperative characteristics of the patients were compared, and patients were classified into two groups according to characteristics related to recurrence: the "recurrence group," consisting of patients in whom prolapse recurred in the operated compartment during the observation period, and the "nonrecurrence group," consisting of the remaining patients. This retrospective study was approved by the First Towakai Hospital Ethics Committee (approval number 109) and conducted in accordance with the principles of the Declaration of Helsinki. Each patient provided written informed consent to report data.
我们研究了 2015 年 8 月至 2017 年 6 月间在我们医院接受 TVM-A2 手术的 203 名膀胱膨出患者的记录，并在手术后至少 48 个月接受了适当的随访护理。我们使用盆底器官脱垂量化（POP-Q）系统评估患者术前解剖状况，使用过度活跃膀胱症状评分（OABSS）评估尿液储存的主观状况， 以及尿流率和残余尿量测量来评估客观排尿功能。手术时间、失血量、伴随手术和并发症也进行了评估。手术后膨出解剖复发和并发症在手术后 3 个月和 12 个月进行评估，然后每年进行一次评估，客观排尿功能在手术后 3 个月通过尿流率和残余尿量测量进行评估。膨出解剖复发定义为 POP-Q 分期 II 或更高。 手术前患者的特征进行了比较，并根据与复发相关的特征将患者分为两组： “复发组”，包括在观察期间手术区域复发脱垂的患者，以及“非复发组”，包括其余患者。本回顾性研究已获得第一塔瓦凯医院伦理委员会批准（批准号 109），并按照《赫尔辛基宣言》原则进行。每位患者均提供了书面知情同意以报告数据。
All values were calculated as means SDs. EZR (The R Foundation for Statistical Computing, Vienna, Austria) was used to perform statistical analysis. The Mann-Whitney test and binomial logistic regression analysis were used to compare the preoperative characteristics of the recurrence and nonrecurrence groups. The cutoff values for predictors of recurrence were determined by receiver operating characteristic (ROC) curve analysis, and the chisquare test was used to compare the two groups.
所有数值均计算为平均值 标准差。使用 EZR（奥地利维也纳统计计算基金会）进行统计分析。 使用曼-惠特尼 检验和二项逻辑回归分析比较复发组和非复发组的术前特征。复发预测因子的截断值由受试者工作特征（ROC）曲线分析确定，卡方检验用于比较两组。
To determine which surgical procedure would be performed, we examined the patients, while they were under general anesthesia, just before surgery. TVM-A2 was performed in cases of cystocele with POP-Q stage III, in which the main descending point of prolapse was in the anterior wall and no prolapse of the posterior wall was obvious. Patients with stage IV cystoceles were not included in this study
为确定将执行哪种手术程序，我们在手术前检查了患者，当他们处于全身麻醉状态时。在膀胱脱垂伴有 POP-Q III 期的情况下，我们执行了 TVM-A2 手术，其中脱垂的主要下降点位于前壁，后壁没有明显的脱垂。本研究不包括患有 IV 期膀胱脱垂的患者。
because those lesions were treated with laparoscopic sacrocolpopexy (LSC) or anterior-posterior TVM surgery. The mesh used was a self-cut polypropylene mesh (Polyform ; Boston Scientific, Natick, MA, USA). The mesh previously used in Prolift-type anterior TVM surgery and the mesh used in TVM-A2 are depicted in Figure 1. The surgical technique was basically the same as that previously reported ; the difference was that we omitted the puncture for the anterior mesh arms and instead added a fixation suture to the vaginal wall at the origin of the anterior mesh arms (Figure 1b). The addition of this suture ensured better extension of the mesh and better fixation to the vaginal wall on the lateral side of the bladder.
因为这些病变是通过腹腔镜骶骨盆底固定术（LSC）或前后 TVM 手术治疗的。使用的网格是自行切割的聚丙烯网格（Polyform ;波士顿科学公司，马萨诸塞州内蒂克，美国）。在 Prolift 型前置 TVM 手术中先前使用的网格和 TVM-A2 中使用的网格如图 1 所示。手术技术基本与先前报道的相同 ；不同之处在于我们省略了前置网格臂的穿刺，而是在前置网格臂的起源处向阴道壁添加了固定缝线（图 1b）。添加这根缝线确保了网格的更好延伸和更好地固定在膀胱侧的阴道壁上。

Results 结果

The background information about the 203 patients included in this study is listed in Table 1. The mean age was years, the mean body mass index was , the mean number of deliveries was , and all the patients were postmenopausal. The mean duration of observation was 51.9 months, and in most (176) cases, the most descending compartment point was on the anterior vaginal wall. The POP-Q stage was III in all cases. Six patients ( ) had undergone hysterectomy, two ( ) had undergone LSC, and one ( ) had undergone TVM surgery; no patient underwent
203 名患者的背景信息列在表 1 中。平均年龄为 岁，平均体重指数为 ，平均分娩次数为 ，所有患者均为绝经后。观察期平均持续时间为 51.9 个月，在大多数（176）病例中，最下降区点位于阴道前壁。所有病例的 POP-Q 分期均为 III 期。六名患者（ ）接受过子宫切除术，两名（ ）接受过 LSC 手术，一名（ ）接受过 TVM 手术；没有患者接受。
native tissue repair. The mean operation time was 33.1 min , and the mean amount of blood loss was 22 mL . Concomitant procedures included posterior colporrhaphy in 10 patients ( ), cervical amputation in 9 patients , and cervical polypectomy in 1 patient ( ; Table 2). Perioperative complications included blood loss of more than 200 mL in one patient and bladder injury in two patients (1.0%; Table 2).
本地组织修复。平均手术时间为 33.1 分钟，平均失血量为 22 毫升。伴随手术包括 10 名患者进行后阴道成形术（ ），9 名患者进行宫颈截断术 ，1 名患者进行宫颈息肉切除术（ ；表 2）。围手术期并发症包括 1 名患者失血超过 200 毫升 ，2 名患者膀胱受伤（1.0%；表 2）。
TABLE 1 Baseline characteristics
表 1 基线特征
Age (years), mean SD (range)
年龄（岁），平均 标准差（范围）
BMI (kg ), mean SD
BMI（kg ），平均 SD
(range)
Parity ( ), mean SD (range)
平均值 ( ), 意味着 标准差 (范围)
Menopause,  绝经，
Follow-up interval (months),
跟进间隔（月），
mean SD (range) 意味着 标准差（范围）
Most descending component (s)
大多数下降组件（s）
Anterior,  前,
Anterior and apical,
前部和顶部，
Apical,  顶端，
POP-Q stage POP-Q 阶段
Stage III,  第三阶段，
After hysterectomy,
子宫切除术后，
History of POP surgery
POP 手术的历史
LSC,  LSC，
TVM,  TVM，
NTR,
Abbreviations: BMI, body mass index; LSC, laparoscopic sacrocolpopexy; NTR, native tissue repair; POP-Q, pelvic organ prolapse-quantification; TVM, transvaginal mesh.
缩写：BMI，身体质量指数；LSC，腹腔镜骶骨盆底固定术；NTR，自体组织修复；POP-Q，盆腔器官脱垂定量化；TVM，经阴道网片。
FIGURE 1 Meshes for Japanese-style anterior transvaginal mesh (TVM) surgery. (a) Transobturator four-arm mesh based on Prolift . (b) Transobturator two-arm mesh. White arrowheads indicate the anterior mesh arms. Black arrowheads indicate the posterior mesh arms. Asterisks indicate additional sutures for fixation
图 1 日本风格前阴道网格（TVM）手术网格。 （a）基于 Prolift 的经阴道四臂网格。 （b）经阴道两臂网格。 白色箭头表示前网格臂。 黑色箭头表示后网格臂。 星号表示额外的缝线用于固定。
Watanabe et al. Watanabe 等。
The 203 patients underwent follow-up for 4 years. The postoperative results are listed in Table 3. Prolapse (POP-Q stage II or higher) occurred in other compartments in 13 patients ( ) and recurred in the operated compartment in 9 patients (4.4%).
203 名患者接受了为期 4 年的随访。手术后的结果列在表 3 中。13 名患者（ ）在其他区域发生脱垂（POP-Q 分期 II 或更高），9 名患者（4.4%）手术区域复发。
TABLE 2 Surgical characteristics
表 2 手术特征
Operation time (min), 操作时间（分钟）， (23-75)
mean SD (range) 意味着 标准差（范围）
Blood loss (mL), mean SD
失血量（mL），平均 标准差
(range)
Simultaneous surgery 同时手术
Posterior colporrhaphy,
后阴道前壁修补术，
Cervical amputation,
颈椎截断，
Removal of cervical polyp,
宫颈息肉切除，
(%)
Perioperative complication
围手术期并发症
Blood loss >200 mL,
失血量>200 毫升，
Bladder injury,  膀胱受伤，
TABLE 3 Surgical outcomes
表 3 手术结果
Recurrence 复发
Total,  总计，
22 (10.8)
In the operated 9 (4.4) compartment, StageII/III, Additional procedures,
在经过的 9 (4.4) 间隔中， StageII/III， 额外程序，
Time to recurrence (months), (12.1-61) mean (range)
时间到复发（月）， （12.1-61）平均 （范围）
In the other compartments,
在其他隔间中，
StageII/III, (%) (3.9)/5 (2.4) Additional procedures,
阶段 II/III， (%) (3.9)/5 (2.4) 额外程序，
4 (2)
Time to recurrence (months), (12.2-54.8) mean (range)
时间到复发（月）， （12.2-54.8）平均 （范围）
Postoperative complication
手术后并发症
Mesh extrusion, (%)
网格挤出， (%)
Chronic pain,  慢性疼痛，

Prolapse in other compartments was classified as POP-Q stage II in eight patients ( ) and as stage III in five patients , and surgical treatment was performed in four patients out of five that were stage III . All the recurrences in the operated compartment were classified as stage II, and none of them necessitated additional treatment. We observed no cases of mesh exposure or chronic pain during the study period. On average, prolapse in other compartments occurred 26.8 months after surgery, and prolapse in the operated compartment recurred 31.4 months after surgery.
脱垂在其他区域被分类为 8 名患者的 POP-Q II 期（ ），在 5 名患者中被分类为 III 期 ，其中 5 名中有 4 名接受了手术治疗 。在手术区域的所有复发病例均被分类为 II 期，无需额外治疗。在研究期间我们未观察到任何网格外露或慢性疼痛病例。平均而言，手术后其他区域的脱垂发生在术后 26.8 个月，手术区域的脱垂在术后 31.4 个月复发。
The results for urination are listed in Table 4. The results were evaluated preoperatively and 3 months later. We found no significant change in the maximum urinary flow rate ( preoperatively, postoperatively; ) or in the average urinary flow rate ( preoperatively, postoperatively; ). Significant improvement was observed in residual urine volume ( 42.1 mL preoperatively, 7.4 mL postoperatively; ); in OABSS question 3 (1.6 preoperatively, 0.9 postoperatively; ); and in OABSS total score (4.6 preoperatively, 3.3 postoperatively; .
结果见表 4。结果在术前和术后 3 个月进行评估。我们发现最大尿流率没有显著变化（ 术前， 术后; ）或平均尿流率（ 术前， 术后; ）。残余尿量有显著改善（术前 42.1 毫升，术后 7.4 毫升; ）；在 OABSS 问题 3（术前 1.6，术后 0.9; ）；以及在 OABSS 总分（术前 4.6，术后 3.3; ）。
To investigate the characteristics predictive of recurrence, we divided the patients into two groups: the 9 patients who suffered recurrence in the operated compartment were in the "recurrence group," and the other 194 were in the "nonrecurrence group." Then, we performed univariable analysis of preoperative characteristics (Table 5). The recurrence group was significantly younger, and point Ba was higher than in the nonrecurrence group. Point Aa also tended to be higher in the recurrence group. Multivariable analysis suggested a significant association between recurrence and age (odds ratio, confidence interval, ) and between recurrence and point Ba (odds ratio, 1.467; confidence interval, 1.989-9.452; ; Table 6). The ROC curves for the cutoff values for recurrence indicated
为了调查预测复发的特征，我们将患者分为两组：手术区域发生复发的 9 名患者属于“复发组”，其他 194 名患者属于“非复发组”。然后，我们对术前特征进行了单变量分析（表 5）。复发组的年龄显著较小，点 Ba 高于非复发组。点 Aa 在复发组也倾向较高。多变量分析表明复发与年龄（比值比， 置信区间， ）以及复发与点 Ba（比值比，1.467； 置信区间，1.989-9.452； ；表 6）之间存在显著关联。用于复发截断值的 ROC 曲线表明
TABLE 4 Changes in urological parameters by surgery and OABSS
表 4 手术和 OABSS 对泌尿学参数的变化
Baseline  基线 3 months postoperatively
3 个月术后 		-Value  -值
, average (range)  ，平均（范围） 0.749
, average (range)  ，平均（范围） 0.14
Residual urine , average (range)
残余尿 ，平均（范围）
OABSS-3, average (range)
OABSS-3，平均（范围）
OABSS-total, average (range)
\footnotetext{
Abbreviations: OABSS, overactive symptom score; Q max, maximum flow rate; Q average, average flow rate
缩写：OABSS，过度活跃症状评分；Q max，最大流量；Q average，平均流量
TABLE 5 Univariate analyses for variables between groups
表 5 组间变量的单变量分析
Recurrence  复发 Nonrecurrence  不再发生 -Value  -值
Age (years), mean SD
年龄（岁），平均 标准差		 0.034
BMI , mean SD
BMI ，意味着 标准差		 0.67
Parity , mean SD
平均 ，意味着 标准差		 0.72
Point Aa, mean SD
点 Aa，意味着 标准差		 0.065
Point Ba, mean SD
点巴，意味着 标准差
Point C, mean SD
点 C，意味着 标准差		 0.84
Note: Point Aa, Point Ba, Point C: as defined in the POP-Q system, respectively.
注意：点 Aa，点 Ba，点 C：分别在 POP-Q 系统中定义。
TABLE 6 Multivariate logistic analysis for the risk factor of recurrence related to the explanately valuables
表 6 复发风险因素的多变量 logistic 分析与解释性价值相关
95 confidence limits 95 置信限制
Explanatory valuables 解释性贵重物品 Partial regression coefficient
部分回归系数		 Odds ratio 几率比 Lower limit 下限 Upper limit 上限 -Value  -值
Age 年龄 -0.203 0.816 0.697 0.956 0.012
Point Aa 点 Aa -0.048 0.953 0.546 1.663 0.865
Point Ba 点巴 1.467 4.336 1.989 9.452
Note: Point Aa, Point Ba: as defined in the POP-Q system, respectively.
注意：Point Aa，Point Ba：分别在 POP-Q 系统中定义。
TABLE 7 Comparison of recurrence in each group separated by cut off values
表 7 每组根据截断值分开的复发比较
Recurrence 复发
Yes 是 No 不 -Value  -值
Age 年龄 0.019
66 years, or less
66 年，或更少		 5 42
More than 66 years
超过 66 年		 4 152
Point Ba 点巴 0.001
Less than 3.5 小于 3.5 2 140
3.5 or more 3.5 或更高 7 54
Note: Point Ba: as defined in the POP-Q system.
注意：Point Ba：如 POP-Q 系统中定义的那样。
an age cutoff of 66 years (area under the curve, 0.71 ; ) and 3.5 cm of point Ba (area under the curve, ). The classifications of the patients into the two groups according to these cutoff values are shown in Table 7. The rate of prolapse recurrence was significant among patients younger than 66 years and those with point Ba of being 3.5 cm or more .
年龄截止年龄为 66 岁（曲线下面积，0.71; ）和 Ba 点为 3.5 厘米（曲线下面积， ）。根据这些截止值将患者分类为两组的情况如表 7 所示。在年龄小于 66 岁的患者中 和 Ba 点为 3.5 厘米或更多的患者中 ，脱垂复发率显著。

Discussion 讨论

In this study, we retrospectively investigated the medium-term efficacy and safety of TVM-A2, which is Japanese-style TVM surgery without anterior mesh arms, and we sought to verify whether anterior mesh arms were necessary in this procedure.
在这项研究中，我们对 TVM-A2 的中期疗效和安全性进行了回顾性调查，TVM-A2 是一种没有前置网格臂的日本风格 TVM 手术，我们试图验证在这个程序中是否需要前置网格臂。
In this study, nine patients (4.4%) suffered anatomical recurrence of prolapse in the operated compartment during the observation period of 51.8 months. In a previous report on the results of TVM surgery with transobturator four-arm mesh, TVM surgery with Prolift mesh for cystocele had to be reported in of cases within 2 years after surgery. Kdous and Zhioua reported that the 3-year anatomical success rate of TVM surgery for cystocele with a transobturator fourarm mesh as well as Prolift mesh was . Takahashi et al. reported a 12-month anatomical success rate of There was also a report by a surgeon almost identical to the present study, which showed an anatomical recurrence rate of at 2 years postoperatively. In this study, we used the transobturator two-arm mesh, which produced therapeutic effects equivalent to those previously reported with the transobturator four-arm mesh. Therefore, the anterior mesh arms may be omitted in Japanese-style TVM surgery.
在这项研究中，九名患者（4.4%）在 51.8 个月的观察期内在手术区域发生了脱垂的解剖复发。在先前关于使用经阴道四臂网格进行 TVM 手术的结果的报告中，必须在手术后 2 年内报告膀胱膨出的 Prolift 网格的 例病例。 Kdous 和 Zhioua 报告说，使用经阴道四臂网格以及 Prolift 网格进行膀胱膨出的 TVM 手术的 3 年解剖成功率为 。 Takahashi 等人报告了 12 个月的解剖成功率为 。还有一份几乎与本研究相同的外科医生的报告，显示了术后 2 年的解剖复发率为 。 在这项研究中，我们使用了经阴道两臂网格，其治疗效果与先前报道的经阴道四臂网格相当。因此，在日本式 TVM 手术中可能可以省略前置网格臂。
In transvaginal surgery for cystocele, the Uphold LITE vaginal mesh (Boston Scientific), which is a twoarm mesh like TVM-A2, has been reported to show good results. However, although Uphold mesh is indicated for uterine prolapse, it is not suitable for cases of cystocele alone. In addition, a larger area of dissection near SSL is needed for Uphold mesh than for transobturator TVM. This wider area of dissection has been reported to cause more cases of voiding difficulties in patients with SSL suspension, and we try to minimize the extent of dissection during TVM-A2. For these reasons, we prefer TVM-A2 over
在膀胱膨出的阴道手术中，据报道，Uphold LITE 阴道网格（波士顿科学公司）表现良好，这是一种类似于 TVM-A2 的双臂网格。 然而，尽管 Uphold 网格适用于子宫脱垂，但不适用于单纯的膀胱膨出病例。此外，与经阴道外路 TVM 相比，Uphold 网格需要更大范围的在 SSL 附近的解剖。据报道，这种更广泛的解剖范围会导致 SSL 悬吊患者出现更多排尿困难的病例， 因此我们尽量减少 TVM-A2 过程中的解剖范围。出于这些原因，我们更倾向于选择 TVM-A2。
Watanabe et al. Watanabe 等。
surgery with Uphold mesh for cystocele. LSC has also been reported to be as effective for the treatment of cystocele as TVM surgery. However, LSC is not recommended for patients with glaucoma because it is performed with the patient's head lowered, and it is unsuitable for elderly patients because it is longer than TVM surgery. In contrast, TVM surgery is performed with patients in the supine position, in addition to being shorter, and so it is suitable for a wide range of patients.
手术使用 Uphold 网格治疗膀胱脱垂。据报道，LSC 对治疗膀胱脱垂与 TVM 手术一样有效。 然而，不建议青光眼患者接受 LSC 手术，因为该手术需要患者头部低垂，对于年长患者也不适合，因为手术时间比 TVM 手术长。 相比之下，TVM 手术是在仰卧位患者上进行的，手术时间较短，适用于广泛的患者。
With regard to bladder injury, Halaska et al. reported a rate of in TVM surgery for vaginal prolapse, and Kato et al. reported rates of . In our study, bladder injury occurred in two patients ; this rate is comparable with those previously reported. With regard to intraoperative bleeding, only one patient lost more than 200 mL of blood, and no patients required blood transfusion; these results were similar to those reported by Kato et al.
关于膀胱损伤，Halaska 等人报道了阴道脱垂 TVM 手术中的发生率 ，而 Kato 等人报道了 的发生率。在我们的研究中，有两名患者发生了膀胱损伤；这一比率与先前报道的情况相当。至于术中出血，只有一名患者失血超过 200 毫升，没有患者需要输血；这些结果与 Kato 等人的报道相似。
Mesh exposure occurred in of Lucot et al.'s patients, in of Long et al.'s patients, and in of Kato et al.'s and Takahashi et al.'s patients, whereas we observed none in our study. According to Takeyama et al. and Kato et al., this was due to the factors that the mesh insertion site was placed under the full-thickness of the vaginal wall and that the inserted mesh was extended appropriately to prevent it from contracting and bending. Other factors include the lack of simultaneous hysterectomy and an inverted T-shaped incision.
网格暴露发生在 Lucot 等人的患者中的 ，在 Long 等人的患者中的 ，以及在 Kato 等人和 Takahashi 等人的患者中的 和 ，而我们的研究中没有观察到。根据 Takeyama 等人和 Kato 等人的说法，这是由于网格插入位置位于阴道壁全厚度下 ，并且插入的网格适当延伸以防止其收缩和弯曲 。其他因素包括缺乏同时子宫切除和倒 T 形切口 。
Vaiyapuri et al. reported chronic pain 12 months after surgery in of patients, and Sherif et al. reported a rate of Long et al. reported a rate 10 years after surgery, and Takahashi et al. reported a rate 12 months after surgery. In contrast, none of our patients reported chronic pain. The cause of pain was reported to be contraction of the polypropylene mesh, and the mechanism of contraction is inflammation caused by the nonabsorbable thread and polyfilament or by inaccurate anchoring.
Vaiyapuri 等人报道手术后 的患者慢性疼痛， ，Sherif 等人报道 的比率，Long 等人报道手术后 10 年的 比率， ，Takahashi 等人报道手术后 12 个月的 比率。 相比之下，我们的患者没有报告慢性疼痛。疼痛的原因被报道为聚丙烯网的收缩， ，而收缩的机制是由于不可吸收的线和聚丙烯纤维引起的炎症 或不准确的固定 。
In our study, the patients who suffered prolapse recurrence after TVM-A2 were younger and had more advanced cystocele than did patients without recurrence. Vergeldt et al. reported that old age is a factor in the development of ; however, Whiteside et al. reported that younger age is a factor for recurrence after surgery for POP. Whiteside et al. also speculated that younger women who develop POP may have genetic factors and connective tissue vulnerability that may predispose them to postoperative recurrence of prolapse. Although our findings do not clarify the reason, recurrence was indeed significantly more common among patients younger than 66 years.
在我们的研究中，TVM-A2 术后出现脱垂复发的患者比没有复发的患者年龄更小，且膀胱膨出更为严重。 Vergeldt 等人报告称，老年是 发展的一个因素；然而，Whiteside 等人报告称，年轻是腹膜腹膨出手术后复发的一个因素。 Whiteside 等人还推测，年轻女性患有腹膜腹膨出可能具有遗传因素和结缔组织易损性，这可能使她们更容易在术后复发脱垂。 尽管我们的发现并未阐明原因，但 66 岁以下的患者中复发确实更为普遍。
Friedman et al. and Padoa et al. reported that a preoperative point Ba of being 3 cm or more was a risk factor for recurrence. Our results were almost in agreement with this assertion. Takeyama et al. reported that in young patients with advanced cystocele and uterine prolapse who underwent TVM surgery with a transobturator four-arm mesh similar to the Prolift type, the rate of recurrence was significantly higher than in older patients. Padoa et al. reported that in of patients who underwent robot-assisted sacrocolpopexy for advanced cystocele, prolapse recurred. TVM-A2 may be suitable for such cases, but the results may be the same even with a different technique. This issue remains to be resolved.
Friedman 等人和 Padoa 等人报告称，术前 Ba 点为 3 厘米或更多是复发的危险因素。 我们的结果几乎与这一说法一致。Takeyama 等人报告称，在接受类似于 Prolift 型号的经阴道腹股沟四臂网格 TVM 手术的年轻患者中，晚期膀胱脱垂和子宫脱垂的复发率明显高于年长患者。 Padoa 等人报告称，在接受机器人辅助骶骨盆底重建术治疗晚期膀胱脱垂的患者中，脱垂复发。 TVM-A2 可能适用于这类病例，但即使采用不同技术，结果可能相同。这个问题仍有待解决。
This study had several limitations. It was a singlearm, retrospective study, and the number of enrolled patients who underwent 4 -year follow-up was not large (203). Therefore, it is difficult to determine a clear causal relationship.
这项研究有几个局限性。这是一项单臂、回顾性研究，接受了 4 年随访的入组患者数量不大（203）。因此，很难确定明确的因果关系。
In conclusion, the mid-term results of TVM-A2 were as safe and favorable as those of four-arm TVM surgery, which suggests that the anterior mesh arms may not be necessary in Japanese-style TVM surgery if anchoring to the firm tissue around the ischial spine is accurate. However, the rate of prolapse recurrence is significantly higher in patients aged 66 or younger and in those with advanced cystocele with point Ba of being 3.5 cm or more, as is the case with other techniques. This information must be provided to patients preoperatively.
总之，TVM-A2 的中期结果与四臂 TVM 手术一样安全和有利，这表明如果固定到坐骨棘周围的坚固组织准确，那么在日本式 TVM 手术中前置网状臂可能是不必要的。然而，在 66 岁或以下的患者以及那些患有 3.5 厘米或更多 Ba 点的晚期膀胱膨出的患者中，脱垂复发率显著较高，就像其他技术一样。这些信息必须在术前向患者提供。

Author contributions 作者贡献

Masaki Watanabe: data curation, visualization, and writing (original draft). Masami Takeyama: conceptualization, project administration, supervision, and data validation. Tomoko Kuwata: data curation and formal analysis. Hiromi Kashihara: data curation and formal analysis. Chikako Kato: data curation and formal analysis. Miho Hirota: data validation and manuscript review and editing.
渡辺正樹：数据整理、可视化和撰写（原始草稿）。竹山真美：概念化、项目管理、监督和数据验证。桑田智子：数据整理和形式分析。柏原浩美：数据整理和形式分析。加藤千佳子：数据整理和形式分析。广田美穗：数据验证和手稿审阅和编辑。

Acknowledgments 致谢

The authors would like to acknowledge Akiko Fujisaki, MD, of Itellas limited company (Tokyo, Japan) for assistance with statistical analysis.
作者们要感谢伊藤晶子（日本东京）的 Itellas 有限公司的 MD，对统计分析的帮助。

Conflict of interest 利益冲突

The authors declare no conflicts of interest for this article.
作者声明本文没有利益冲突。

Data availability statement
数据可用性声明

The data that support the findings of this study are available from the corresponding author, Masaki Watanabe, upon reasonable request.
本研究结果的支持数据可根据合理请求从对应作者 Masaki Watanabe 处获取。

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  1. Received: March 242022. 收到：2022 年 3 月 24 日。
    Accepted: June 132022. 接受：2022 年 6 月 13 日。
    Correspondence: Masaki Watanabe, First Towakai Hospital, 2-17 Miyanocho, Takatsuki city, Osaka 569-0081, Japan.
    通讯：日本大阪府高槻市宫野町 2-17 的第一东脇医院，邮编 569-0081，日本。