Doumerc Nicolas, Mouly Patrick, Thanwerdas Jacky, Vazzoler Nicolas, Khedis Mehdi, Huyghe Eric, Soulié Michel, Plante Pierre
Service d'Urologie et d'Andrologie, Hôpital de Rangueil, Toulouse, France.
Prog Urol. 2006 Feb;16(1):58-61.
To evaluate the efficacy and safety of a porcine biomaterial (Pelvicol) in the transvaginal surgical treatment of urogenital prolapse.
Prospective study from June 2001 to February 2004 based on 132 patients with a mean age of 67.6 +/- 9.89 years presenting major urogenital prolapse: 132 cystoceles and 84 rectoceles with 100% and 63.4% of grade 2 or 3, respectively. Patients were evaluated by questionnaire and clinical examination at 1 month, 6 months, 12 months and 24 months after the operation. Two hundred and sixteen Pelvicol implants were inserted via a vaginal approach: 132 anterior implants and 84 posterior implants.
The mean follow-up was 21 months [range: 6-24]. No intraoperative complication was observed. The postoperative complication rate was 11.3% (15/132) including 1 prosthetic exposure with a favourable outcome. After 6 months, 1 recurrence of cystoceles and 1 recurrence of rectoceles were found in 132 patients. Out of the 117 patients followed up for 12 months, 6 presented with grade 2 cystoceles and 1 grade 2 rectoceles. After 24 months, out of the 107 patients evaluated, 18 cystoceles and 9 rectoceles of grade 2 or 3 were found. Globally, 83.1% of patients did not present with grade 2 or 3 recurrences after 24 months. Safety was considered to be good with 10% of moderate pelvic pain and 6% of de novo dyspareunia at 12 months. The overall satisfaction rate was 94%.
These preliminary results demonstrate an efficacy of 83.1% at 24 months and the good safety of Pelvicol in the transvaginal surgical treatment of urogenital prolapse.
评估一种猪生物材料（Pelvicol）在经阴道手术治疗泌尿生殖系统脱垂中的疗效和安全性。
2001年6月至2004年2月的前瞻性研究，基于132例平均年龄为67.6±9.89岁的患有严重泌尿生殖系统脱垂的患者：132例膀胱膨出和84例直肠膨出，分别有100%和63.4%为2级或3级。在术后1个月、6个月、12个月和24个月通过问卷调查和临床检查对患者进行评估。通过阴道途径植入216个Pelvicol植入物：132个前植入物和84个后植入物。
平均随访时间为21个月[范围：6 - 24个月]。未观察到术中并发症。术后并发症发生率为11.3%（15/132），包括1例假体暴露，结局良好。6个月后，132例患者中发现1例膀胱膨出复发和1例直肠膨出复发。在117例随访12个月的患者中，6例出现2级膀胱膨出，1例出现2级直肠膨出。24个月后，在107例接受评估的患者中，发现18例2级或3级膀胱膨出和9例2级或3级直肠膨出。总体而言，24个月后83.1%的患者未出现2级或3级复发。安全性被认为良好，12个月时10%的患者有中度盆腔疼痛，6%的患者出现新发性交困难。总体满意率为94%。
这些初步结果表明，在经阴道手术治疗泌尿生殖系统脱垂中，Pelvicol在24个月时的疗效为83.1%，且安全性良好。
