Could the vaginal wall sling still have a role after FDA's warning? the functional outcomes at 20 years.

IF 4.7 Q2 MATERIALS SCIENCE, BIOMATERIALS ACS Applied Bio Materials Pub Date : 2022-03-07 eCollection Date: 2022-01-01 DOI:10.1177/17562872221084391

Ester Illiano, Francesco Trama, Alessandro Marchesi, Consuelo Fabi, Stefano Brancorsini, Elisabetta Costantini

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Abstract

Introduction: Aims of this study were to evaluate the functional outcomes of a vaginal wall sling technique in patients with stress urinary incontinence at 20 years after surgery and to evaluate the patient's satisfaction after the surgical procedure.

Material and methods: This was a prospective single-center study on patients with stress urinary incontinence who underwent in situ vaginal sling surgery. Presurgery evaluation included history, pelvic examination, and urodynamic test. All patients completed Urogenital Distress Inventory-6 (UDI-6) questionnaire. They underwent checkups at 1, 3, 6, and 12 months postoperatively and then annually. The sling was created by making a rectangle (15-20 × 25 mm) on the anterior vaginal wall and it was reinforced by one roll of Marlex mesh on each side of the sling. The sutures were passed through the vagina at the suprapubic level after suprapubic incision, above the rectus fascia and tied without excessive tension.

Results: From May 1996 to May 2002, 40 women underwent vaginal wall sling surgery for stress urinary incontinence. Last visit was performed on 20 women between March 2020 and April 2020. Median follow-up was 251.3 months (20.9 years) (range = 204.3-285.4 months). The success rate after 5 years of surgical procedure was 80%; over 5 years, the objective cure rate was 45%. Considering only the group of 13 patients with pure stress urinary incontinence, the objective cure rate decreased to 38%, in particular 7 years after surgery. Women who did not resolve their urinary incontinence needed to undergo a new treatment. At over 5 years after surgery, there was an increase in urgency (p = 0.001) and voiding symptoms (p = 0.008) and urgency urinary incontinence (UUI) (p = 0.04). Ninety-five percent were very much worse or much worse according to the Patient Global Impression of Improvement (PGI-I) scale.

Conclusion: The in situ vaginal wall sling does not guarantee good long-term functional outcomes in women with stress urinary incontinence.

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在美国食品药品监督管理局发出警告后，阴道壁吊带还能发挥作用吗？20年的功能结果

引言：本研究的目的是评估阴道壁悬吊技术在压力性尿失禁患者术后20年的功能结果，并评估患者在手术后的满意度。材料和方法：这是一项前瞻性的单中心研究，研究对象为接受原位阴道吊带手术的压力性尿失禁患者。术前评估包括病史、骨盆检查和尿动力学检查。所有患者均完成了泌尿生殖道疼痛调查表-6（UDI-6）。他们在术后1、3、6和12个月接受检查，然后每年进行一次。吊索是通过制作一个矩形（15-20 × 25mm），并且通过吊带每侧上的一卷Marlex网片加固。在耻骨上切口后，缝合线在耻骨上水平穿过阴道，在直肌筋膜上方，并在没有过度张力的情况下打结。结果：从1996年5月至2002年5月，40名女性因压力性尿失禁接受了阴道壁悬吊术。最后一次访问是在2020年3月至2020年4月期间对20名女性进行的。中位随访时间为251.3个月（20.9年）（范围 = 204.3–285.4个月）。手术5年后成功率为80%；5年来，客观治愈率为45%。仅考虑13例单纯压力性尿失禁患者，客观治愈率降至38%，尤其是术后7年。没有解决尿失禁的妇女需要接受新的治疗。在手术后5年以上，紧急情况有所增加（p = 0.001）和排尿症状（p = 0.008）和紧迫性尿失禁（UUI）（p = 0.04）。根据患者整体改善印象（PGI-I）量表，95%的患者情况非常糟糕或更糟。结论：原位阴道壁吊带不能保证女性压力性尿失禁患者获得良好的长期功能结果。

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来源期刊

ACS Applied Bio Materials Chemistry-Chemistry (all)

CiteScore

9.40

自引率

2.10%

发文量

464

期刊介绍： ACS Applied Bio Materials is an interdisciplinary journal publishing original research covering all aspects of biomaterials and biointerfaces including and beyond the traditional biosensing, biomedical and therapeutic applications. The journal is devoted to reports of new and original experimental and theoretical research of an applied nature that integrates knowledge in the areas of materials, engineering, physics, bioscience, and chemistry into important bio applications. The journal is specifically interested in work that addresses the relationship between structure and function and assesses the stability and degradation of materials under relevant environmental and biological conditions.