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.