Lamblin Gery, Boix Solene, Moret Stéphanie, Nohuz Erdogan, Chene Gautier, Hamid David
Gynecology Surgery Department, Hôpital Femme Mère Enfant, Bron, France.
Université Claude Bernard Lyon 1, Lyon, France.
Int Urogynecol J. 2025 Jan;36(1):205-211. doi: 10.1007/s00192-024-06005-w. Epub 2024 Dec 10.
Various treatment options are currently available for the management of stress urinary incontinence (SUI). This study was aimed at determining the effectiveness and safety profile of Bulkamid, and identify predictive factors of clinical success.
This retrospective study conducted in two French urogynecology university centers between September 2019 and December 2023 included all patients with urinary incontinence who received Bulkamid.
Among the 320 patients included (median age 58.2 years), the median follow-up was 24 months. Urethral hypermobility was found in 93.4% of patients (n = 282) and 92% (n = 275) had a positive cough test. At 1 month, 68.7% of patients (n = 220) achieved clinical success, 25.6% (n = 82) improved, and 5.6% (n = 18) reported failure. At last follow-up, 63.7% of patients (n = 204) were still cured, 21.9% (n = 70) had improved, and 14.4% (n = 46) reported failure. Among the 16 patients with overactive bladder (OAB) 43.7% had a Patient Global Improvement (PGI) score of 1-2 at 1 month and 50.0% at last follow-up, with significant difference compared with patients without OAB, 81.0% had a PGI score of 1-2 at 1 month and 74.8% at last follow-up (p = 0.0006 and p = 0.04 respectively). Regarding complications, acute urinary retention occurred in 3.1% of patients (n = 10), urinary infections in 2.2% (n = 7), and transient hematuria in 7.2% (n = 23). In multivariate analysis, follow-up time was significantly associated with failure compared with improvement/cure (OR = 1.05, 95% CI 1.02-1.08, p = 0.0002).
The present large series of patients reported the effectiveness of Bulkamid injection, a minimally invasive procedure providing good clinical outcomes at 2 years' follow-up.
目前有多种治疗压力性尿失禁（SUI）的方法。本研究旨在确定Bulkamid的有效性和安全性，并识别临床成功的预测因素。
这项回顾性研究于2019年9月至2023年12月在法国两个大学泌尿妇科中心进行，纳入了所有接受Bulkamid治疗的尿失禁患者。
纳入的320例患者（中位年龄58.2岁）中，中位随访时间为24个月。93.4%（n = 282）的患者存在尿道活动过度，92%（n = 275）的患者咳嗽试验呈阳性。1个月时，68.7%（n = 220）的患者取得临床成功，25.6%（n = 82）的患者病情改善，5.6%（n = 18）的患者治疗失败。在最后一次随访时，63.7%（n = 204）的患者仍治愈，21.9%（n = 70）的患者病情改善，14.4%（n = 46）的患者治疗失败。在16例膀胱过度活动症（OAB）患者中，43.7%在1个月时患者整体改善（PGI）评分为1 - 2分，在最后一次随访时为50.0%，与无OAB的患者相比有显著差异，81.0%在1个月时PGI评分为1 - 2分，在最后一次随访时为74.8%（分别为p = 0.0006和p = 0.04）。关于并发症，3.1%（n = 10）的患者发生急性尿潴留，2.2%（n = 7）的患者发生泌尿系统感染，7.2%（n = 23）的患者出现短暂血尿。在多因素分析中，与病情改善/治愈相比，随访时间与治疗失败显著相关（OR = 1.05，95%CI 1.02 - 1.08，p = 0.0002）。
本研究纳入大量患者，报告了Bulkamid注射治疗的有效性，这是一种微创手术，在2年随访时能提供良好的临床效果。
