de Tayrac R, Cortesse A, Fernandez H, Fritel X
Service de Gynécologie-Obstétrique, Hôpital Carémeau, place Professeur-Robert-Debré, Nîmes.
J Gynecol Obstet Biol Reprod (Paris). 2005 Nov;34(7 Pt 1):702-10. doi: 10.1016/s0368-2315(05)82904-7.
The aim of the study was to evaluate feasibility and results of ambulatory transurethral injections of Macroplastique using the system MIS under local anaesthesia, for treatment of female stress urinary incontinence.
We have performed a prospective multicentre study which has enrolled 20 patients between January 2003 and May 2004. Mean age was 72.8 ans (range 40 to 91). Preoperative inclusion criterias were positive stress test, 24 hours PAD test more than 10 g and post-void residual less than 100 ml. Urethral hypermobility was present in 8 patients (42.1%), and 3 patients was diagnosed as intrinsic sphincter deficiency (16.7%) on urodynamics examination. Pre and post-operative evaluation of urinary symptoms and quality of life were performed with the MHU score (Mesure du Handicap Urinaire), the Ditrovie score and the Contilife scale. The Macroplastique implant (Uroplasty) contains silicone and a bioabsorbable gel. Injections were perfomed under the mid-urethral mucosa (2.5 ml at 6 hours and 1.25 ml at 2 and 10 hours) using the system MIS (Uroplasty). No cystoscopy was required and the mean operative time was 15 minutes.
The procedure was feasible under pure local anaesthesia in all cases. No intra-operative complications occurred. Postoperative complications had included 2/19 local pain (10.5%), 3/19 minimal urethrorrhagia (15.8%) and 6/19 urinary retentions (31.6%), which were treated by heterologous intermittent catheterization during 3 to 20 days. Eight patients returned home the same day (42.1%). The mean hospital stay was 2.3 days. Mean postoperative follow-up was 8.3 months (range 2.7 to 19.1). No patient required a second injection. Results had shown a 36.9% success rate (7/19), 52.6% improvement (10/19) and 10.5% failure (2/19). At follow-up, stress test was negative in 66.7% of patients (12/18) and PAD test was<10 g in 66.7% (10/15). Modifications on maximal flow rate were non significant after injections. Postoperatively, all urinary symptoms were improved except nocturia and voiding difficulties. Quality of life was improved on all parameters.
The surgical treatment of female stress urinary incontinence by transurethral injections of Macroplastique using the system MIS under local anaesthesia was feasible in all cases with a success or improvement rate of 89.5% at a mean follow-up of 8.3 months. Ambulatory treatment was compromised by the high rate of postoperative urinary retention (31.6%).
本研究旨在评估在局部麻醉下使用MIS系统门诊经尿道注射Macroplastique治疗女性压力性尿失禁的可行性及效果。
我们进行了一项前瞻性多中心研究,于2003年1月至2004年5月招募了20例患者。平均年龄为72.8岁(范围40至91岁)。术前纳入标准为压力试验阳性、24小时尿垫试验超过10克且排尿后残余尿量少于100毫升。8例患者(42.1%)存在尿道活动过度,3例患者在尿动力学检查中被诊断为固有括约肌缺陷(16.7%)。使用MHU评分(尿功能障碍测量)、Ditrovie评分和Contilife量表对术前和术后的泌尿系统症状及生活质量进行评估。Macroplastique植入物(Uroplasty)包含硅酮和一种可生物吸收的凝胶。使用MIS系统(Uroplasty)在尿道中段黏膜下进行注射(6小时时注射2.5毫升,2小时和10小时时各注射1.25毫升)。无需进行膀胱镜检查,平均手术时间为15分钟。
该手术在所有病例的单纯局部麻醉下均可行。术中未发生并发症。术后并发症包括2/19例局部疼痛(10.5%)、3/19例轻微尿道出血(15.8%)和6/19例尿潴留(31.6%),通过异体间歇性导尿治疗3至20天。8例患者当天出院(42.1%)。平均住院时间为2.3天。术后平均随访8.3个月(范围2.7至19.1个月)。无患者需要第二次注射。结果显示成功率为36.9%(7/19),改善率为52.6%(10/19),失败率为10.5%(2/19)。随访时,66.7%的患者(12/18)压力试验为阴性,66.7%(10/15)的患者尿垫试验<10克。注射后最大尿流率的变化不显著。术后,除夜尿症和排尿困难外,所有泌尿系统症状均有所改善。生活质量在所有参数上均得到改善。
在局部麻醉下使用MIS系统经尿道注射Macroplastique治疗女性压力性尿失禁在所有病例中均可行,平均随访8.3个月时成功率或改善率为89.5%。门诊治疗因术后尿潴留发生率高(31.6%)而受到影响。