Carroll Timothy F, Christie Alana, Foreman Melissa, Kuprasertkul Amy, Khatri Gaurav, Zimmern Philippe E
Department of Urology, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
Simmons Comprehensive Cancer Center, Biostatistics, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
Low Urin Tract Symptoms. 2021 Jul;13(3):335-340. doi: 10.1111/luts.12372. Epub 2020 Dec 22.
To evaluate the durability of Macroplastique® (MPQ) volume and configuration in women with stress urinary incontinence (SUI) secondary to intrinsic sphincter deficiency (ISD) using serial three-dimensional ultrasound (3DUS) measurements.
Following Institutional Review Board approval, charts of women with SUI and ISD (defined based on leak point pressure; lateral imaging of urethral support without hypermobility) who underwent MPQ were reviewed from a prospectively maintained database. All had at least two serial transperineal 3DUS measurements with no MPQ or other bulking agent injection between measurements. 3DUS was performed using the Philips IU22 ultrasound system with endovaginal 3D 9-3V end-fire probe typically at 6-8 weeks post-injection and yearly thereafter. The same imaging team blinded to clinical outcomes evaluated volume and configuration (circumferential/symmetric or asymmetric) at each 3DUS.
Between 2011 and 2019, 62 of 174 women met study criteria. Those with prior other bulking agent injection or having ≤1 3DUS follow-up were excluded. Seventy-one percent of patients had one injection, while the remainder had two or more (29%). Median time between first and second 3DUS was 12 months. The mean change in MPQ volume between the first and last 3DUS measurement was -0.2 cc (95% CI: -0.5 to 0.004; P = .054). A median of 5.0 cc were injected in each patient. Forty-seven women had symmetric MPQ at first 3DUS, of whom only five (11%) had a follow-up 3DUS showing asymmetric MPQ distribution.
At mid-term follow-up, repeat transperineal 3DUS after MPQ injection revealed minimal change in volume and configuration in the urethral wall.
采用连续三维超声（3DUS）测量，评估Macroplastique®（MPQ）在因内在括约肌缺陷（ISD）导致压力性尿失禁（SUI）的女性中的体积和形态的持久性。
经机构审查委员会批准后，从一个前瞻性维护的数据库中回顾了接受MPQ治疗的SUI和ISD女性（根据漏尿点压力定义；尿道支持的侧向成像且无尿道活动过度）的病历。所有患者至少进行了两次连续的经会阴3DUS测量，测量期间未注射MPQ或其他填充剂。使用飞利浦IU22超声系统，配备经阴道3D 9-3V端射探头进行3DUS检查，通常在注射后6-8周进行，此后每年进行一次。同一成像团队在不知晓临床结果的情况下，在每次3DUS检查时评估体积和形态（圆周对称或不对称）。
2011年至2019年期间，174名女性中有62名符合研究标准。排除那些先前注射过其他填充剂或3DUS随访次数≤1次的患者。71%的患者注射了一次，其余患者注射了两次或更多次（29%）。第一次和第二次3DUS检查之间的中位时间为12个月。第一次和最后一次3DUS测量之间MPQ体积的平均变化为-0.2 cc（95%CI：-0.5至0.004；P = 0.054）。每位患者注射的MPQ中位数为5.0 cc。47名女性在第一次3DUS检查时MPQ形态对称，其中只有5名（11%）在3DUS随访中显示MPQ分布不对称。
在中期随访中，MPQ注射后重复经会阴3DUS检查显示尿道壁的体积和形态变化极小。
