Capobianco Giampiero, Azzena Antonio, Saderi Laura, Dessole Francesco, Dessole Salvatore, Sotgiu Giovanni
Gynecologic and Obstetric Clinic, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Viale San Pietro 12, 07100, Sassari, Italy.
Department of Obstetrics and Gynaecology, Conegliano Veneto Hospital, Conegliano, Veneto, Italy.
Int Urogynecol J. 2018 Sep;29(9):1239-1247. doi: 10.1007/s00192-018-3703-6. Epub 2018 Jun 23.
The aim of the present systematic review and meta-analysis was to assess the effectiveness and safety of injections of the new bulking agent Urolastic® in the treatment of patients with stress urinary incontinence (SUI).
A systematic search was carried out to select observational and experimental studies on Urolastic® in female patients with SUI. Three different databases, Pubmed, the Cochrane Central Register of Controlled Trials, and Scopus, were used to retrieve scientific articles published from their inception to 31 January 2018.
Eight full texts were evaluated but only five were selected for the qualitative and quantitative analyses. Duration of follow-up after Urolastic® injections was significantly heterogeneous, ranging from 6 to 24 months. Secondary injections were needed in 16.7%-35.0% of the treated patients. The pooled proportion of secondary injections was 20% (95% CI: 15%-24%; I: 0%). Subjective improvement, measured by different means (i.e., patient global impression of improvement PGI-I score) was only assessed by 40% of the selected papers and was > 80% in two cohorts. The objective treatment success was evaluated by four (80.0%) papers and was achieved in all cohorts with a wide proportional range: from 32.7% (i.e., patients without objective SUI symptom cough tests and with a negative pad test) to 67.0%. Its pooled proportion was 57% (95% CI: 38%-75%; I: 82.3%).
Urolastic® showed effectiveness in patients with SUI during a follow-up period of 6-24 months.
本系统评价和荟萃分析的目的是评估新型填充剂Urolastic®注射治疗压力性尿失禁（SUI）患者的有效性和安全性。
进行系统检索，以选择关于Urolastic®治疗女性SUI患者的观察性和实验性研究。使用三个不同的数据库，即PubMed、Cochrane对照试验中央注册库和Scopus，检索从建库至2018年1月31日发表的科学文章。
共评估了8篇全文，但仅5篇被选入定性和定量分析。Urolastic®注射后的随访时间显著异质，范围为6至24个月。16.7%-35.0%的治疗患者需要二次注射。二次注射的合并比例为20%（95%CI：15%-24%；I²：0%）。仅40%的入选论文通过不同方式（如患者总体改善印象PGI-I评分）评估了主观改善情况，且在两个队列中>80%。4篇（80.0%）论文评估了客观治疗成功率，所有队列均实现了客观治疗成功，比例范围较广：从32.7%（即无压力性尿失禁客观症状咳嗽试验且护垫试验阴性的患者）至67.0%。其合并比例为57%（95%CI：38%-75%；I²：82.3%）。
Urolastic®在6至24个月的随访期内对压力性尿失禁患者显示出有效性。
