Section of Voiding Dysfunction, Female Urology and Reconstruction, Cleveland Clinic Florida, Weston, Florida 33331-3609, USA.
J Urol. 2010 Apr;183(4):1444-9. doi: 10.1016/j.juro.2009.12.038. Epub 2010 Feb 20.
We evaluated the durability of the urethral bulking agent Macroplastique for stress urinary incontinence in a 24-month study in women with a previously documented successful outcome 12 months after the last injection.
In a multicenter study females diagnosed with stress urinary incontinence primarily due to intrinsic sphincter deficiency successfully treated with Macroplastique, defined as 1 or greater Stamey grade improvement 12 months from baseline, were followed for 24 months to assess the sustained therapeutic response. Outcome measures were Stamey grade, Patient Global Impression of Improvement, Physician Assessment of Improvement, 1-hour pad weight, Incontinence Quality of Life scores and safety assessment.
At 24 months 56 of 67 patients (84%) had sustained success since 12 months, of whom 45 of 67 (67%) were dry (Stamey grade 0). Of the dry patients at 12 months 33 of 38 (87%) maintained cure at 24 months. Also, 12 of 29 patients (41%) considered improved at 12 months were dry at 24 months. Overall Incontinence Quality of Life scores and all subscales showed statistically significant improvement from baseline (p <0.001). Mean pad weight was 24 gm at baseline, and 4 gm at 12 and 24 months. Patient and physician assessments rated 85% of patients dry or markedly improved 24 months after the last treatment.
Substantial, durable results were sustained during 2 years with 84% of patients maintaining significant Stamey grade improvement from the 12-month assessment. Two-thirds of patients were dry at 24 months. The durability of Macroplastique shows its effectiveness as a viable long-term therapy for female stress urinary incontinence primarily due to intrinsic sphincter deficiency.
我们评估了Macroplastique 尿道填充剂在先前记录的成功结果 12 个月后最后一次注射后的 24 个月研究中治疗压力性尿失禁的耐用性。
在一项多中心研究中，患有压力性尿失禁的女性，主要由于内在括约肌缺陷成功接受 Macroplastique 治疗，定义为从基线开始 12 个月时 Stamey 等级提高 1 或更高，随访 24 个月以评估持续的治疗反应。结果测量包括 Stamey 等级、患者整体改善印象、医生评估的改善、1 小时垫重、尿失禁生活质量评分和安全性评估。
在 24 个月时，67 例患者中有 56 例（84%）自 12 个月以来持续成功，其中 45 例（67%）为干燥（Stamey 等级 0）。在 12 个月时干燥的患者中，33 例（87%）在 24 个月时保持治愈。同样，在 12 个月时认为改善的 29 例患者中有 12 例在 24 个月时为干燥。总体尿失禁生活质量评分和所有子量表与基线相比均有统计学显著改善（p<0.001）。垫重平均值为 24 克，基线时为 4 克，12 个月和 24 个月时为 4 克。患者和医生评估在最后一次治疗后 24 个月时将 85%的患者评为干燥或明显改善。
在 2 年期间，有 84%的患者保持了 12 个月评估时的显著 Stamey 等级改善，因此获得了实质性和持久的结果。三分之二的患者在 24 个月时干燥。Macroplastique 的耐用性表明其作为女性压力性尿失禁的可行长期治疗方法的有效性，主要由于内在括约肌缺陷。
