Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Eur Urol. 2010 Jun;57(6):973-9. doi: 10.1016/j.eururo.2010.02.018. Epub 2010 Feb 19.
No studies have been published comparing the U- and H-type methods of the TVT SECUR (TVT-S) procedure.
Our aim was to compare the efficacy and safety of the two types of TVT-S for female stress urinary incontinence (SUI).
DESIGN, SETTING, AND PARTICIPANTS: Women with urodynamic SUI were enrolled in this 12-mo multicenter randomized study.
Subjects were randomly allocated to either the U- or H-type method of TVT-S.
Pre- and postoperative evaluations included a standing stress test, the Sandvik questionnaire, the Incontinence Quality of Life (I-QOL) questionnaire, and the International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS). Patients' satisfaction and complications were evaluated. Objective and subjective cures were defined as no leakage on the stress test and responses on the Sandvik questionnaire, respectively. We compared the surgical outcomes between the two methods.
Of 285 women, 144 had the U-type method and 141 had the H-type method. Objective cure rates were 87.5% for the U-type method and 80.1% for the H-type method (p=0.091). Subjective cure rates were 77.1% for the U-type method and 75.7% for the H-type method (p=0.786). Improvement in I-QOL and domain scores of the ICIQ-FLUTS (filling and incontinence sum, QOL score), and patients' satisfaction favored the U-type method. There were three cases of intraoperative vaginal wall perforation, one case of increased bleeding, and three cases of temporary postoperative retention. A power calculation was not performed, and some baseline characteristics were not balanced between the two methods.
Both methods of TVT-S provided comparable cure rates for female SUI. However, QOL and treatment satisfaction favored the U-type method.
The protocol of this study was not registered.
目前尚未有研究比较 TVT-SECUR（TVT-S）手术的 U 型和 H 型方法。
本研究旨在比较两种 TVT-S 治疗女性压力性尿失禁（SUI）的疗效和安全性。
设计、地点和参与者：本 12 个月多中心随机研究纳入了尿动力学 SUI 女性患者。
受试者随机分配至 TVT-S 的 U 型或 H 型方法。
术前和术后评估包括站立压力测试、Sandvik 问卷、尿失禁生活质量（I-QOL）问卷和国际尿失禁咨询问卷-女性下尿路症状（ICIQ-FLUTS）。评估患者满意度和并发症。客观和主观治愈率分别定义为压力测试无漏尿和 Sandvik 问卷有反应。我们比较了两种方法的手术结果。
285 名女性中，144 名接受了 U 型方法，141 名接受了 H 型方法。U 型方法的客观治愈率为 87.5%，H 型方法为 80.1%（p=0.091）。U 型方法的主观治愈率为 77.1%，H 型方法为 75.7%（p=0.786）。I-QOL 和 ICIQ-FLUTS 领域评分（充盈和失禁总分、生活质量评分）改善以及患者满意度均倾向于 U 型方法。术中发生 3 例阴道壁穿孔、1 例出血增加和 3 例暂时性术后潴留。未进行功效计算，且两种方法之间的一些基线特征未平衡。
两种 TVT-S 方法治疗女性 SUI 的治愈率相当。然而，U 型方法在生活质量和治疗满意度方面更具优势。
本研究方案未注册。
