This study aimed to report 3-year completed follow-up of the safety and efficacy of Macroplastique® (MPQ) in women with stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD).
This is a retrospective analysis of all women who completed 3-year follow-up post-MPQ injection(s) at ten medical centers. We used the ROSE registry data report of Macroplastique® [Macroplastique® Real-time Observation of Safety and Effectiveness (ROSE) registry P040050/PAS001 on 2017]. Subjective incontinence outcome and adverse effects were assessed.
The study included all patients (n = 70) who completed 3-year follow-up after the last MPQ injection. Twenty-four of 70 (34%) patients had two injections; 21/70 (30%) patients reported Stamey grade 0 and 28/70 (40%) reported Stamey grade 1. The overall patient satisfaction was 68% who completed 3-year follow-up. The composite success rate (I-QoL, PGI-S, and Stamey grade improvement) was 51.4%. No serious adverse events (AE) were reported within the completed 3-year follow-up.
MPQ was found to be safe and efficacious for the treatment of SUI secondary to ISD in women. The overall high satisfaction rate was sustained from baseline to 3 years post-injection. Most complications were minor and transient without sequelae.
International urogynecology journal. 2021 Jun 08 [Epub ahead of print]
Gamal Ghoniem, Bilal Farhan, Mashrin Lira Chowdhury, Yanjun Chen
Department of Urology, University of California Irvine (UCI), Irvine, CA, USA. ., Department of Urology, University of California Irvine (UCI), Irvine, CA, USA., Institute for Clinical and Translational Science, University of California Irvine (UCI), Irvine, CA, USA.
PubMed http://www.ncbi.nlm.nih.gov/pubmed/34100973