正确面对FDA对经阴道植入网片手术治疗盆腔器官脱垂的公告

自2008年起,美国食品药品监督管理局（FDA）颁布了一系列有关经阴道植入网片（transvaginal mesh,TVM）手术治疗盆腔器官脱垂（pelvic organ prolapse,POP）的警示与公告,至今十余年来,盆底重建手术的网片植入与自体组织修补引起了全球妇科泌尿领域学者与医生的广泛关注。基于现有的临床研究,美国、加拿大、英国、澳大利亚等国家先后发布了TVM的禁售令。以上一系列举措对我国妇科盆底重建领域有较大影响,应予以高度重视,要科学客观面对FDA对TVM手术治疗POP的公告。     

Evaluating the efficacy of the single-incision uphold system for pelvic organ prolapse repair

Objective

The aim of this study was to assess the efficacy and clinical outcomes of pelvic floor reconstruction with transvaginal mesh of the Uphold? Vaginal Support System (Boston Scientific Corporation).

Role of MR imaging in surgical planning and prediction of successful surgical repair of pelvic organ prolapse

ObjectiveTo determine the role of magnetic resonance imaging (MRI) in surgical planning for females with pelvic organ prolapsed (POP) and to determine the clinical utility of MR imaging in predicting successful surgical repair.MethodsFifteen patients with different varieties of pelvic floor dysfunction and 15 nulliparous females as control subjects were studied by magnetic resonance imaging (static and dynamic). Intraoperative findings related to POP were correlated to MRI findings. In the symptomatic patients, magnetic resonance imaging was repeated within 6–12 months after surgery.ResultsPreoperative MRI and operative findings showed a significant correlation in all types of prolapse, except rectocele. On the other hand preoperative pelvic examination and operative findings were significantly correlated for cystocele, rectocele and vaginal cuff prolapse (r = 0.75, P < 0.008). Preoperative magnetic resonance imaging added information that changed the management in 40% of symptomatic women. Postoperative magnetic resonance imaging showed normal pelvic floor in asymptomatic patients (n = 13). Abnormal imaging findings were found in patients with persistent postoperative or de novo complaints (n = 2).ConclusionMagnetic resonance imaging can accurately localize pelvic floor defects, evaluate success or failure of surgical procedures, predict the need for more extensive reconstruction, and identify complications.     

改良盆底重建术治疗盆腔器官脱垂的临床研究

目的:探讨改良盆底重建术治疗盆腔器官脱垂(POP)的临床实用性。方法:选取59例POP患者,其中19例采用改良盆底重建术(A组),20例采用阴式子宫全切除术+阴道前壁"斜拉桥"式修补术(B组);20例采用传统阴式子宫全切除术+阴道前壁修补术(C组)。比较3组患者的围手术期各项指标情况及术后复发、阴道深度、性生活保持情况及疼痛不适等并发症情况。结果:(1)3组患者的手术时间、术中出血量、术后病率、术后性生活保持率及术后随访主观复发率比较差异均无统计学意义(P0.05);3组的术后留置尿管时间及客观复发率两两比较差异均有统计学意义(P0.05),A组的留置尿管时间最短,C组的客观复发率较高。C组术后的平均阴道深度浅于A、B组,差异有统计学意义(P=0.000);但后两组比较差异无统计学意义。3组患者均无严重并发症发生。结论:3种术式均能短期内解决POP问题,改良盆底重建术术式简单易操作,可保持盆底结构及功能的完整性,短期内具有较好的疗效,但远期疗效尚待循证。     

The efficacy and complications of using transvaginal mesh to treat pelvic organ prolapse in Taiwan: A 10-year review

Transvaginal mesh (TVM) insertion for the treatment of pelvic organ prolapse (POP) is significantly associated with lower failure rates, although its use remains controversial due to the potential risk of mesh-related complications. In this review, we collected the published literature regarding the use of TVM to treat POP in an attempt to assess both the efficacy and complications related to TVM usage in Taiwan.We searched 25 English language articles using PubMed related to TVM in Taiwan from 2010 to 2019. The present article focuses on the efficacy and complications of TVM and analyzes the data.There were 25 studies on TVM selected for this review. Regarding their success rate, 21 out of the 22 studies (95.5%) had more than a 90% objective success rate. Twenty studies (90.9%) had less than 10% major complications of TVM. Twenty out of the 25 studies (80.0%) had 5% or less mesh exposure. For self-cut TVM and the later single-incision TVM, both the complication rates and exposure rates decreased. The rate of de novo dyspareunia ranged from 2.6% to 14.3%, and the incidence decreased yearly from 2011 to 2019.This review showed both the high treatment efficacy and low complication rate of TVM usage for the short-term treatment of POP in Taiwan. However, a longer-term study is needed to draw a conclusion regarding the safety of this treatment.     

Risk factors for pelvic organ prolapse.

OBJECTIVES: To evaluate the risk factors for pelvic organ prolapse (POP) and to determine the relationship between these risk factors and stage or other components of POP. METHODS: 244 patients with primary POP and 314 women without POP were included. Age, parity, smoking, body mass index (BMI), menopause, and hormone replacement therapy (HRT) were investigated. RESULT: Independent risk factors for POP included age over 70, parity higher than 3, and menopause. Age, parity, menopause, and HRT were significantly associated with stage of POP. Genital hiatus (GH) and perineal body (PB) showed a significant positive and negative correlation with age and parity, respectively. Menopause and HRT were also associated with them. CONCLUSION: Age, parity and menopause are possible risk factors of POP and associated with the lengths of GH and PB in POP women. Further, these risk factors and HRT are significantly correlated with the severity of the disease.     

Surgical repair of pelvic organ prolapse and follow-up: An institutional multi-center experience

AIM: To investigate the effects of the Elevate Anterior and Posterior transvaginal mesh procedure on 30 patients affected by pelvic organ prolapse (POP) at 12 mo follow-up. METHODS: Between September 2011 and September 2012, a prospective multicenter observational study enrolled 30 consecutive patients with POP-Q ≥ stage II. After a preoperative evaluation, patients underwent prolapse repair utilizing the Elevate Anterior and Posterior Prolapse Repair System (American Medical Systems, Minnetonka, MN, United States). Operative technique was standardized and performed by the same surgical team under spinal or general anesthesia. Patients were evaluated postoperatively at 1, 3, 6 and 12 mo. RESULTS: All 30 patients completed the 12 mo follow-up. The mean age was 65.3 years (range 49-81 years) and average hospital stay was 4.5 d. The mean operative time was 65 min (range 40-120 min). Related adverse events reported were mesh extrusions (6.7%) and post void residual urine volume (13.3%). There were no visceral injuries, no infection of the mesh, and no symptoms of recurrent prolapse. All quality-of-life scores significantly improved from baseline. CONCLUSION: One year’s follow-up of our 30 patients confirms the safety and the efficacy of the Elevate Anterior and Posterior transvaginal mesh procedure for POP treatment. Our final results are comforting but longer term follow-up is ongoing.     

Retrospective multicentre study of the new minimally invasive mesh repair devices for pelvic organ prolapse

Objectives  To assess the complications and short-term outcomes of prolapse repair mesh devices used in the management of female pelvic organ prolapse (POP).
Design  Retrospective cohort study.
Setting  Multicentre study involving a tertiary referral urogynaecology unit and two district general hospitals.
Population  329 women who underwent surgical management of prolapse with various prolapse repair mesh devices in the period between January 2005 and December 2006.
Methods  Women were identified from theatre records. An independent clinician performed a case notes review during the period March to May 2007.
Main Outcome Measures  Complication rates and the short-term cure at 3-month follow-up (defined as ≤stage I prolapse on the POP-Q or Baden Walker scoring systems).
Results  A total of 289 women were included: 219 (76%) used the Gynecare prolapse repair mesh devices, while 70 women (24%) used the American Medical Systems prolapse repair mesh devices. Operative complications included: bladder injury (1.6%), rectal injury (1.1%) and two women with serious vascular injuries. Postoperative complications included: buttock pain (5.2%), vaginal erosion (10%), one woman with bladder erosion and two women (0.7%) with serious infection, leading to necrotising fasciitis in one woman. Short-term cure rates in different groups varied from 94 to 100%, depending on vaginal compartment and device used. In total 15 women (5%) had persistent prolapse at 3-month follow up.
Conclusion  The new prolapse repair mesh devices demonstrate excellent short-term cure and low morbidity rates. However, some complications are serious and require highly specialised management. Rigorous evaluation by means of independent, controlled studies is urgently required.     

Risk factors for prolapse recurrence after vaginal repair

OBJECTIVE: The purpose of this study was to determine factors that are associated with recurrent prolapse. STUDY DESIGN: Of 389 women who underwent vaginal prolapse and incontinence between June 1996 and May 1999, 176 women had 1-year follow-up evaluations. Recurrent prolapse was analyzed by both pelvic organ prolapse quantification stage and centimeter measurements that were relative to the hymen. Logistic regression was used to determine odds ratios and 95% CI for factors that were associated with recurrent prolapse. RESULTS: One year after surgery, 102 women (58%) had recurrent prolapse (>/=stage II). Seventeen women (10%) had prolapse >/=1 cm beyond the hymen. Age <60 years (odds ratio, 3.2; 95% CI, 1.6-6.4; P = .001) and preoperative pelvic organ prolapse quantification stage III or IV (odds ratio, 2.7; 95% CI, 1.3-5.3; P = .005) were associated with a greater likelihood of recurrent prolapse (>/=stage II) at 1 year. CONCLUSION: Younger women and women with more advanced prolapse are more likely to experience recurrent prolapse after vaginal repair.     

Vaginal mesh colpopexy for the treatment of concomitant full thickness rectal and pelvic organ prolapse: a case series

Objective

To present our case series of concomitant rectal and pelvic organ prolapse (POP) treated with vaginal colpopexy with synthetic mesh.

Study design

Charts of patients with full thickness rectal prolapse and POP were reviewed for presenting symptoms, physical examination with POP-Q including rectal prolapse evaluation, and perioperative complications and outcomes.

Results

Four patients aged 63-78 were identified with full thickness rectal prolapse and POP. All of them had symptoms related to both conditions. Rectal prolapse protrusion ranged from 2 cm to 3 cm outside the anus. All patients had vaginal mesh colpopexy; two of them with anterior and posterior vaginal mesh and 2 with posterior mesh only. At a follow-up of 6-44 months, all patients had resolution of both POP and rectal prolapse signs and symptoms.

Conclusion

Vaginal colpopexy with mesh may be a unique treatment to address both POP and full thickness rectal prolapse in selected patients. Further research is needed to determine the safety and efficacy of this method.     

Impact of total vaginal mesh surgery for pelvic organ prolapse on female sexual function

Objective

To evaluate the short-term impact of surgical repair with total transvaginal mesh (TVM) on sexual function among women with pelvic organ prolapse (POP).

Methods

Twenty-seven sexually active women who underwent total TVM procedures for symptomatic POP at Buddhist Dalin Tzu Chi General Hospital between 2007 and 2010 were included in the retrospective study. Preoperative and postoperative assessments included pelvic examination using the POP quantification (POP-Q) system, urodynamic studies, and a personal interview to evaluate urinary and sexual symptoms via the urogenital distress inventory (UDI-6), incontinence impact questionnaire (IIQ-7), and female sexual function index (FSFI).

Results

The mean patient age was 51.4 years (range 36–68 years) and the mean parity was 2.7 (range 0–4). Regarding POP-Q parameters, there were significant improvements at points Aa, Ba, C, Ap, and Bp after surgery (P < 0.001). Similarly, the UDI-6 and IIQ-7 scores significantly dropped postoperatively (P < 0.01). After surgery, the scores for the dyspareunia and the lubrication domains of FSFI worsened significantly (P < 0.05). There was no significant change in other domains (desire, arousal, orgasm, satisfaction, and total score; P > 0.05). Two-thirds (66.7%) of women had a lower total FSFI score postoperatively.

Conclusion

TVM surgery was found to contribute successfully to the anatomic correction of POP, but individual domains of sexual function sometimes worsened.     

Risk factors and management of vaginal mesh erosion after pelvic organ prolapse surgery

Objective

Mesh erosion is a serious and not uncommon complication in women undergoing vaginal mesh repair. We hypothesized that mesh erosion is associated with the patient’s comorbidities, surgical procedures, and mesh material. The aims of this study were to identify the risk factors and optimal management for mesh erosion.

Trans-vaginal mesh surgery for management of recurrent pelvic organ prolapse following abdominal sacrocolpopexy

Objective

To evaluate the outcome of transvaginal mesh surgery as a management of recurrent pelvic organ prolapse, in patients previously treated with sacrocolpopexy.

Laparoscopic surgical repair of pelvic organ prolapse and female stress urinary incontinence

Pelvic organ prolapse (POP) occurs in a relatively big population of women which is continuously increasing and is associated with a variety of urinary bowel and sexual symptoms. As this problem magnifies, the need for surgical repair is increasing relatively. The main goals of surgical repair for POP include: no anatomic prolapse, no functional symptoms, patient satisfaction and avoidance of complications, goals that cannot always be fully achieved. The decision for the type of surgery depends of various factors such as patient characteristics and prolapsed compartment but also by the surgeon expertise. The laparoscopic approach is already the gold standard procedure for many urologic procedures and can also be used for the treatment of POP and stress urinary incontinence. Herein, we review the literature about the available data concerning laparoscopic surgery techniques for treating POP.     

经阴道植入TiLOOP网片的盆底重建术的临床疗效和安全性分析

目的:评价经阴道植入轻型钛化聚丙烯网片TiLOOP的盆底重建术的临床短期疗效和安全性。方法:回顾性分析南京医科大学附属无锡妇幼保健院2017年11月至2019年7月,以阴道前壁膨出Ⅲ~Ⅳ度为主的50例盆腔器官脱垂（POP）患者,对其实施经阴道植入TiLOOP网片的盆底重建术,其中自行裁剪TiLOOP网片的“协和式”盆底...     

经阴网片全盆重建术治疗重度盆腔器官脱垂中长期临床疗效评价

目的 探讨经阴网片全盆重建手术治疗盆腔器官脱垂的疗效及并发症,评估该手术的有效性和安全性。方法 回顾性分析2007年1月至2014年6月在广州医科大学附属第一医院因盆腔器官脱垂行经阴网片全盆重建术110例患者的临床资料,比较手术前后盆腔器官脱垂定量分期法(POP-Q)各指示点位置,评价总体客观治愈率及复发率。采用盆底功能障碍性疾病症状问卷简表(PFDI-20)等相关问卷评分评价主观治愈率以及术后尿失禁相关症状改善情况。结果 110例患者中失访12例（12/110, 10.91%）,其中1例因心血管疾病术后1年余死亡,随访98例（98/110, 89.09%）。随访时间6～90个月,中位随访时间：48个月。110例患者年龄(65.30±8.00)岁;绝经时间(14.01±9.08)年;采用POP-Q分期评价,术后15例（15/98,15.31%）出现复发,其中11例POP-Q分期Ⅱ期,无主观症状不需再次手术,4例阴道顶端复发（POP-Q Ⅲ期）,需再次手术治疗。术后主观治愈率95.92%(94/98）,客观治愈率84.69%(83/98）;网片挛缩4例（4/98, 4.08%）,网片外露11例（11/98,11.22%）。术后PFDI-20评分与术前比较,差异有统计学意义(P<0.05);术后性生活13例,其中性生活质量5例满意,6例患者较术前差,2例配偶出现性交疼痛;患者总体术后满意度评分满意率95.91%(94/98)。结论 经阴网片全盆重建术用于治疗重度盆腔器官脱垂主、客观治愈率高,不仅能达到较好的解剖学复位,对患者的盆腔器官脱垂相关症状有明显改善,术后满意度高且长期疗效稳定,但对性生活质量无明显改善。