Department of Neurourology, CTO-Spinal Cord Unit, AOU Città della Salute e della Scienza di Torino, Turin, Italy.
Neurourol Urodyn. 2020 Jun;39(5):1523-1528. doi: 10.1002/nau.24388. Epub 2020 May 14.
The aim of the present work is to analyze the safety profile, effectiveness, and favorable and unfavorable predictors of clinical outcome in urethral bulking with Bulkamid, and to better identify the ideal candidate for the procedure.
We included all consecutive female patients treated with urethral bulking with Bulkamid at our institution within 2 years. Patients were affected by stress urinary incontinence (SUI) or mixed incontinence. Incontinence severity was classified as "mild" (urinary leakage <50 g/die), "moderate" (50-200 g/die), or "severe" (>200 g/die) at 24-hours pad test. Clinical success was defined as "dry" (no pads); clinical failure included "partial improvement" (>50% 24-hours pad test reduction) and "no benefit" (<50% 24-hours pad test reduction). The χ and Mann-Whitney tests were performed to assess the predictors of clinical outcome.
The success rate was 36.1% (n = 35). Forty-three patients (44.3%) reported continence improvement. Complications included eight urinary retention cases (8.2%). Statistically significant correlation was observed between incontinence severity and clinical outcome in thee χ test (P = .008). No significant correlation was found between functional outcome and urodynamic incontinence features, postoperative urinary retention, previous pelvic surgery, age, and other physiological, pathological, and urodynamics characteristics. Urinary retention following the surgical procedure appeared to be related to clinical success with nonsignificant P value (P = .10).
Bulkamid procedure could be proposed with good results in elderly patients or in patients requiring a low-invasive procedure with low risk of complications, affected either by SUI or mixed incontinence and with mild to moderate incontinence. Previous training to clean intermittent self-catheterization maneuver should be performed.
本研究旨在分析经尿道注射巴氯芬（Bulkamid）治疗的安全性、有效性以及临床结局的有利和不利预测因素，并更好地确定该治疗方法的理想适用人群。
我们纳入了本机构在 2 年内接受经尿道注射巴氯芬治疗的所有连续女性患者。患者患有压力性尿失禁（SUI）或混合性尿失禁。在 24 小时尿垫试验中，尿失禁严重程度分为“轻度”（漏尿<50g/天）、“中度”（50-200g/天）或“重度”（>200g/天）。临床疗效定义为“无漏尿”（不使用尿垫）；临床疗效包括“部分改善”（24 小时尿垫试验减少>50%）和“无获益”（24 小时尿垫试验减少<50%）。采用卡方检验和曼-惠特尼检验评估临床结局的预测因素。
成功率为 36.1%（n=35）。43 例患者（44.3%）报告尿失禁改善。并发症包括 8 例尿潴留（8.2%）。卡方检验显示，尿失禁严重程度与临床结局呈显著相关性（P=0.008）。功能结局与尿动力学性尿失禁特征、术后尿潴留、既往盆腔手术、年龄以及其他生理、病理和尿动力学特征之间无显著相关性。手术后继发尿潴留与临床疗效呈显著相关（P=0.10）。
巴氯芬治疗对于老年患者或需要低侵入性、低并发症风险的患者（无论患有 SUI 还是混合性尿失禁，且尿失禁程度为轻度至中度），具有良好的效果。应提前对间歇性清洁导尿术进行训练。
