Fekete Zoltán, Surányi Andrea, Rénes Lórand, Németh Gábor, Kozinszky Zoltan
Division of Urogynaecology, Department of Obstetrics and Gynaecology, University of Szeged, Semmelweis u. 1., 6725, Szeged, Hungary.
Department of Obstetrics and Gynaecology, Blekinge Hospital, Karlskrona, Sweden.
Trials. 2017 Dec 28;18(1):624. doi: 10.1186/s13063-017-2314-8.
The prevalence of obesity with aging is escalating alarmingly; and pelvic organ prolapse (POP) and stress urinary incontinence (SUI) are now becoming a growing epidemic among the elderly. Synthetic transvaginal mesh has been employed with increasing popularity in the treatment of POP and is usually highly effective in controlling the principal symptoms of prolapse. However, studies have reported that mesh operations provide fairly unfavorable SUI cure rates. Therefore, additional anti-incontinence surgical strategies are increasingly being scrutinized to achieve better postoperative continence without any significant side-effects for patients with both POP and SUI. We hypothesize that the modification with the fixing of the mesh to the mid-urethra is superior to the original transvaginal mesh operation (TVM) with regard to anti-incontinence.
One hundred and thirty patients diagnosed with POP-Q II-III and concomitant SUI requiring surgical treatment will be included in this prospective, randomized, double-blind, controlled clinical trial. Patients will be randomly allocated to receive either original TVM (TVM group, n = 65) or modified TVM surgery (mTVM group, n = 65). As the primary outcome parameter, we will evaluate the objective SUI and POP cure rates. Secondary endpoints include postoperative morbidity as assessed with the International Urogynaecological Association classification and subjective prolapse and incontinence cure rates reported by questionnaires.
Recognizing the importance of an additional surgical procedure for anti-incontinence management, we aim to investigate whether a stabilizing suturing of the mesh to the mid-urethra delivers superior SUI correction compared to the original prosthesis surgery.
ClinicalTrials.gov, NCT02935803. Registered on 20 May 2016.
随着年龄增长，肥胖患病率正以惊人的速度上升；盆腔器官脱垂（POP）和压力性尿失禁（SUI）在老年人中日益成为一种流行病。合成阴道网片在POP治疗中的应用越来越广泛，通常在控制脱垂的主要症状方面非常有效。然而，研究报告称，网片手术的SUI治愈率相当不理想。因此，越来越多的抗尿失禁手术策略正在接受审查，以期在不产生任何重大副作用的情况下，为同时患有POP和SUI的患者实现更好的术后控尿效果。我们假设，在抗尿失禁方面，将网片固定于尿道中段的改良手术优于原始经阴道网片手术（TVM）。
130例被诊断为POP-Q II-III级且伴有SUI需要手术治疗的患者将纳入这项前瞻性、随机、双盲、对照临床试验。患者将被随机分配接受原始TVM（TVM组，n = 65）或改良TVM手术（mTVM组，n = 65）。作为主要结局参数，我们将评估客观SUI和POP治愈率。次要终点包括根据国际妇科学协会分类评估的术后发病率以及问卷报告的主观脱垂和尿失禁治愈率。
认识到额外手术程序在抗尿失禁管理中的重要性，我们旨在研究将网片稳定缝合至尿道中段与原始假体手术相比，是否能提供更好的SUI矫正效果。
ClinicalTrials.gov，NCT02935803。于2016年5月20日注册。
