Appell Rodney A, Juma Saad, Wells W Glen, Lenihan John P, Klimberg Ira W, Kanellos Angelo, Reilley Sandra F
Department of Urology, Baylor College of Medicine, Houston, Texas, USA.
Neurourol Urodyn. 2006;25(4):331-6. doi: 10.1002/nau.20185.
This prospective, randomized, controlled clinical trial was performed to demonstrate the 12 months safety and efficacy of transurethral radiofrequency energy (RF) collagen micro-remodeling in women with stress urinary incontinence (SUI).
Women with SUI, bladder outlet hypermobility, and leak point pressure (LPP) > or =60 cmH(2)O were randomized to RF micro-remodeling or "sham treatment." Adverse events (AEs) were recorded. Incidence of > or =10 point incontinence quality of life (I-QOL) score improvement, a magnitude of improvement with a demonstrated responsiveness to patient satisfaction with treatment and to > or =25% reduction in both incontinence episode frequency and stress pad weight, served as a subjective outcome measurement. Change in mean LPP served as an objective outcome measurement.
110 women underwent RF micro-remodeling and 63 underwent virtually identical "sham treatment" (with the exception of RF delivery). The 12 months RF micro-remodeling safety profile was statistically no different than that of sham treatment (a brief bladder catheterization). Seventy-four percent of women with moderate to severe baseline SUI experienced > or =10 point I-QOL score improvement at 12 months (P = 0.04). Women who underwent RF micro-remodeling demonstrated LPP elevation at 12 months, while sham treated women demonstrated LPP reduction (P = 0.02).
Non-surgical, transurethral RF micro-remodeling is a safe treatment for women with SUI. In women with moderate to severe SUI, this novel therapy resulted in statistically significant improvement in quality of life of a magnitude associated with patient satisfaction with the treatment. Women who underwent RF micro-remodeling demonstrated a statistically significant elevation in mean LPP at 12 months.
本前瞻性、随机、对照临床试验旨在证明经尿道射频能量（RF）胶原微重塑治疗女性压力性尿失禁（SUI）的12个月安全性和有效性。
将患有SUI、膀胱出口活动过度且漏点压力（LPP）≥60 cmH₂O的女性随机分为RF微重塑组或“假治疗”组。记录不良事件（AE）。以失禁生活质量（I-QOL）评分提高≥10分的发生率、与患者对治疗的满意度相关的改善幅度以及失禁发作频率和护垫重量均降低≥25%作为主观结局指标。平均LPP的变化作为客观结局指标。
110名女性接受了RF微重塑，63名女性接受了几乎相同的“假治疗”（除未进行RF传输外）。12个月时RF微重塑的安全性在统计学上与假治疗（短暂膀胱插管）无异。74%基线为中度至重度SUI的女性在12个月时I-QOL评分提高≥10分（P = 0.04）。接受RF微重塑的女性在12个月时LPP升高，而接受假治疗的女性LPP降低（P = 0.02）。
非手术经尿道RF微重塑对女性SUI是一种安全的治疗方法。对于中度至重度SUI的女性，这种新疗法在统计学上使生活质量有显著改善，改善幅度与患者对治疗的满意度相关。接受RF微重塑的女性在12个月时平均LPP有统计学意义的升高。
