Meschia Michele, Bertozzi Rosanna, Pifarotti Paola, Baccichet Roberto, Bernasconi Francesco, Guercio Elso, Magatti Fabio, Minini Gianfranco
Department of Obstetrics and Gynecology, Ospedale G. Fornaroli, Magenta, Italy.
Int Urogynecol J Pelvic Floor Dysfunct. 2007 Nov;18(11):1257-61. doi: 10.1007/s00192-007-0334-8. Epub 2007 Mar 8.
The aim of this study was to compare the morbidity and short-term efficacy of retro-pubic (TVT) and inside-out trans-obturator (TVT-O) sub-urethral sling in the treatment of stress urinary incontinence. This was a prospective multi-centre randomised trial; 231 women with primary stress urinary incontinence were randomised to TVT (114) or TVT-O (117). The International Consultation on Incontinence-Short Form (ICIQ-SF), Women Irritative Prostate Symptoms Score (W-IPSS) and Patient Global Impression of Severity (PGI-S) questionnaires were used to evaluate the impact of incontinence and voiding dysfunction on QoL and to measure the patient's perception of incontinence severity. The primary and secondary outcome measures were rates of success and complications. The SPSS software was used for data analysis. The TVT-O procedure was associated with significantly shorter operation time and with a more extensive use of general anaesthesia when compared with TVT. There were 5 (4%) bladder perforations in the TVT group compared with none in the TVT-O group. Rates of early post-operative urinary retention and voiding difficulty were similar for both groups and no difference was found in the average hospital stay. Six patients (5%) in the TVT-O group complained of thigh pain in the post-operative course. The median follow-up time was 6 months. Two hundred eighteen patients were available for the analysis of outcomes. Subjective and objective cure rates were 92% and 92% in the TVT group and 87% and 89% in the TVT-O group. The ICIQ-SF questionnaire symptoms score showed a highly statistical decrease in both groups, the W-IPSS on the contrary was unchanged. Our data show that both procedures were equally effective in the short-term for the treatment of stress urinary incontinence with a highly significant improvement in incontinence-related QoL.
本研究旨在比较耻骨后（TVT）和经闭孔内出法（TVT-O）尿道下悬吊带术治疗压力性尿失禁的发病率和短期疗效。这是一项前瞻性多中心随机试验；231例原发性压力性尿失禁女性被随机分为TVT组（114例）和TVT-O组（117例）。采用国际尿失禁咨询委员会简表（ICIQ-SF）、女性刺激性前列腺症状评分（W-IPSS）和患者总体严重程度印象（PGI-S）问卷来评估尿失禁和排尿功能障碍对生活质量的影响，并测量患者对尿失禁严重程度的感知。主要和次要结局指标为成功率和并发症发生率。使用SPSS软件进行数据分析。与TVT相比，TVT-O手术的手术时间明显更短，全身麻醉的使用更为广泛。TVT组有5例（4%）膀胱穿孔，而TVT-O组无膀胱穿孔。两组术后早期尿潴留和排尿困难的发生率相似，平均住院时间无差异。TVT-O组有6例患者（5%）在术后出现大腿疼痛。中位随访时间为6个月。218例患者可用于结局分析。TVT组主观和客观治愈率分别为92%和92%，TVT-O组分别为87%和89%。ICIQ-SF问卷症状评分显示两组均有高度统计学意义的下降，相反W-IPSS未改变。我们的数据表明，两种手术在短期内治疗压力性尿失禁同样有效，与尿失禁相关的生活质量有高度显著改善。
