Five-Year Follow-up Study on Safety and Efficacy of Macroplastique® in Female Patients with Stress Urinary Incontinence (the ROSE Study).

Introduction and hypothesis: 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).

Methods: 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).

Results: 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.

Conclusions: 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.