Ghoniem Gamal, Lane Felicia, Farhan Bilal, Gilliam Kelli, Shobeiri S Abbas, Salah Ahmed
University of California, Irvine, CA, USA.
University of Texas Medical Branch, Galveston, TX, USA.
Int Urogynecol J. 2025 Jun 12. doi: 10.1007/s00192-025-06163-5.
This study presents the 5-year study close-out results from the Real-Time Observation of Safety and Effectiveness (ROSE) study, evaluating the safety and efficacy of the Macroplastique® (MPQ) urethral bulking agent for the treatment of stress urinary incontinence (SUI) in women with intrinsic sphincter deficiency (ISD).
The ROSE study was an observational prospective study conducted at 22 US centers that enrolled 274 adult women with ISD-confirmed SUI. Participants underwent MPQ treatment with an option for repeat injections. Follow-up assessments were conducted at 3 months and then annually for 5 years, evaluating SUI severity (Stamey grade), Incontinence Quality of Life (I-QoL), and Patient Global Impression of Satisfaction. Safety outcomes included treatment-related adverse events (AEs) and serious adverse events (SAEs).
Of 274 enrolled participants, 147 (54%) completed the 5-year follow-up. At 5 years, 47.6% 19 (70/147) of women showed improvement in SUI severity as measured by Stamey grade from 20 baseline after their last injection. I-QoL scores improved significantly, from 45 ± 23.9 to 70.9 ± 21 24.5 (1.1, 100). One device-related SAE of urinary retention (0.4%) resolved within 4 months; no 22 late-onset SAEs were reported. The most common minor treatment-related adverse events were 23 urinary tract infections (30.8%) and transient urinary retentions (7.2%). No late-onset SAEs were 24 reported during the 5-year period.
Macroplastique® demonstrated sustained long-term efficacy and safety in managing SUI owing to 27 ISD. These findings reinforce its role as a minimally invasive treatment option with 28 durable outcomes over 5 years.
本研究展示了实时观察安全性与有效性（ROSE）研究的5年研究结束结果，评估了Macroplastique®（MPQ）尿道填充剂治疗内在括约肌缺陷（ISD）女性压力性尿失禁（SUI）的安全性和有效性。
ROSE研究是一项在美国22个中心进行的观察性前瞻性研究，纳入了274名确诊为ISD相关SUI的成年女性。参与者接受了MPQ治疗，并可选择重复注射。在3个月时进行随访评估，然后每年进行一次，共5年，评估SUI严重程度（Stamey分级）、尿失禁生活质量（I-QoL）和患者总体满意度。安全性结果包括与治疗相关的不良事件（AE）和严重不良事件（SAE）。
在274名纳入的参与者中，147名（54%）完成了5年随访。5年时，47.6%（70/147）的女性在最后一次注射后，根据Stamey分级，SUI严重程度较基线时改善。I-QoL评分显著提高，从45±23.9提高到70.9±21.24.5（1.1，100）。1例与器械相关的尿潴留严重不良事件（0.4%）在4个月内得到解决；未报告迟发性严重不良事件。最常见的与治疗相关的轻微不良事件是尿路感染（30.8%）和短暂性尿潴留（7.2%）。在5年期间未报告迟发性严重不良事件。
Macroplastique®在治疗因ISD导致的SUI方面显示出持续的长期疗效和安全性。这些发现强化了其作为一种微创治疗选择的作用，在5年内具有持久的效果。
