Barakat Bara, Hijazi Sameh, Vögeli Thomas-Alexander
Department of Urology and Pediatric Urology, Hospital Viersen, Viersen, Germany.
Department of Urology, Hospital Ibbenbüren, Ibbenbüren, Germany.
Turk J Urol. 2021 May;47(3):216-222. doi: 10.5152/tud.2021.21059.
To evaluate the safety and efficacy rate of polyvinylidene fluoride (PVDF) slings in the treatment of female stress urinary incontinence (SUI).
A prospective pilot study was conducted with women with SUI who underwent PVDF slings. Data regarding subjective (International Consultation on Incontinence Questionnaire - Urinary Incontinence [ICIQ-UI] and International Consultation on Incontinence Questionnaire - Overactive Bladder [ICIQ-OAB]) and objective (stress test and bladder diary) outcomes and complication rates were evaluated. Primary outcomes were objective (negative pad and stress test) and subjective (no leakage episodes) success after a median follow-up of 24 months.
PVDF slings demonstrated a high level of satisfaction with objective cure (transobturator 90% compared with retropubic 100%, P = .90), urgency to urinate, frequency of de novo incontinence (transobturator 90% compared with retropubic 80%, P = .85), ability of physical and sexual activity (transobturator 90% compared with retropubic 100%, P = .90). The multivariate logistic regression model for satisfaction was associated with overall treatment success (odds ratio [OR] = 3.55, 95% confidence interval [CI] 2.32-6.1), greater reduction in ICIQ-UI (OR = 0.85; 95% CI 0.78-1.85) and ICIQ-OAB (OR =0.99; 95% CI 0.89-1.78). The total Female Sexual Function Index (FSFI) score for both groups was 19.3 ± 1.2 and 20.7 ± 1.8, statistically significant when compared with perioperative FSFI score 16.7 ± 1.1 and 17.6 ± 1.4 (P < .001).
PVDF mid-urethral slings are safe with clinically efficacies at 3, 6, 12, and 24-month follow-up for the treatment of SUI. The high level of satisfaction seen after PVDF sling procedures is associated with objective improvement of SUI and fewer slings related complications. Further studies using larger sample sizes with longer and comparative clinical follow-up are required.
评估聚偏氟乙烯（PVDF）吊带治疗女性压力性尿失禁（SUI）的安全性和有效率。
对接受PVDF吊带治疗的SUI女性患者进行一项前瞻性试点研究。评估有关主观（国际尿失禁咨询问卷-尿失禁[ICIQ-UI]和国际尿失禁咨询问卷-膀胱过度活动症[ICIQ-OAB]）和客观（压力试验和膀胱日记）结果及并发症发生率的数据。主要结局指标为在中位随访24个月后客观（护垫阴性和压力试验）和主观（无漏尿事件）成功情况。
PVDF吊带在客观治愈率（经闭孔90%，耻骨后100%，P = 0.90）、尿急、新发尿失禁频率（经闭孔90%，耻骨后80%，P = 0.85）、身体和性活动能力（经闭孔90%，耻骨后100%，P = 0.90）方面显示出较高的满意度。满意度的多因素逻辑回归模型与总体治疗成功相关（比值比[OR]=3.55，95%置信区间[CI]2.32 - 6.1），ICIQ-UI（OR = 0.85；95% CI 0.78 - 1.85）和ICIQ-OAB（OR = 0.99；95% CI 0.89 - 1.78）有更大程度降低。两组的女性性功能指数（FSFI）总分分别为19.3±1.2和20.7±1.8，与围手术期FSFI评分16.7±1.1和17.6±1.4相比有统计学意义（P < 0.001）。
PVDF中尿道吊带治疗SUI在3、6、12和24个月随访时安全且临床有效。PVDF吊带手术后的高满意度与SUI的客观改善及较少的吊带相关并发症有关。需要使用更大样本量、更长时间和对比性临床随访的进一步研究。
