Department of Urology, North Hospital, Aix-Marseille University, APHM, Marseille, France.
Department of Urology, CH Aix-Pertuis, Aix en Provence, France.
World J Urol. 2024 Sep 11;42(1):518. doi: 10.1007/s00345-024-05221-9.
This study aimed to evaluate the efficacy and safety following treatment with Bulkamid for stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence (MUI).
We retrospectively analyzed data of women diagnosed with SUI or stress-predominant MUI who underwent Bulkamid periurethral injection between November 2020 and January 2023 and completed 12 months of follow-up. The primary outcome of the study was to assess patient satisfaction, which was measured on a four-point scale, ranging from cured to worse, and through validated questionaries such as the International Consultation on Incontinence Questionnaire-short Form (ICIQ-UI SF) and Contilife Quality of Life questionnaire.
Of the 70 patients included, 41 (59%) had MUI with predominant stress incontinence. Median age was 59 years (IQR 47-75), with a median BMI of 25 (18-40) and a median number of pregnancies of 2 (0-4). Forty-seven (67%) procedures were performed under sedation and 23 (33%) under local anesthesia. Forty-three (69%) women reported feeling cured or improved at 12 months follow-up and among them, 25 (40%) reported feeling cured. A total of 16 (23%) patients were subsequently treated, in detail 11 (16%) patients underwent MUS positioning, and 5 (7%) had an additional injection of Bulkamid. ICIQ and Contilife QoL showed a significant improvement at 1, 3, 6, and 12 months (all p < 0.001).
Bulkamid injections are an effective and safe treatment option for women with SUI or stress-predominant MUI, providing good outcomes at 12 months.
本研究旨在评估 Bulkamid 治疗压力性尿失禁（SUI）或以压力为主的混合性尿失禁（MUI）的疗效和安全性。
我们回顾性分析了 2020 年 11 月至 2023 年 1 月期间接受 Bulkamid 尿道周围注射治疗并完成 12 个月随访的 SUI 或以压力为主的 MUI 女性患者的数据。本研究的主要结局是评估患者满意度，通过 4 分制进行评估，范围从治愈到更差，并通过国际尿失禁咨询问卷简表（ICIQ-UI SF）和 Contilife 生活质量问卷等经过验证的问卷进行评估。
在 70 名患者中，41 名（59%）患有以压力性尿失禁为主的 MUI。中位年龄为 59 岁（IQR 47-75），中位 BMI 为 25（18-40），中位妊娠次数为 2（0-4）。47 例（67%）手术在镇静下进行，23 例（33%）在局部麻醉下进行。43 名（69%）女性在 12 个月随访时报告感觉治愈或改善，其中 25 名（40%）报告感觉治愈。共有 16 名（23%）患者随后接受了治疗，具体为 11 名（16%）患者行 MUS 定位术，5 名（7%）患者接受了 Bulkamid 追加注射。ICIQ 和 Contilife QoL 在 1、3、6 和 12 个月时均显示出显著改善（均 p<0.001）。
Bulkamid 注射是治疗 SUI 或以压力为主的 MUI 女性的有效且安全的治疗选择，在 12 个月时可获得良好的结果。
