Manufacturers of Macroplastique® for urethral bulking have not previously reported exposures as potential complications. This study was aimed at identifying presenting symptoms, management, and outcomes in patients experiencing urethral or bladder exposures.
A retrospective case series from 2010 to 2019 was performed in an academic affiliated hospital system. Participants were 18-89 years old and received Macroplastique® urethral bulking for treatment of stress urinary incontinence. Charts were identified through diagnosis and procedure codes relating to injections of urethral bulking agents and foreign bodies in the bladder or urethra. Factors evaluated were patient history and presenting symptoms, diagnostic evaluation, treatment, and outcomes using frequency tables for categorical values and statistical distribution with median and interquartile ranges (IQR) for continuous variables.
After review of 1,269 charts, 580 cases met the inclusion criteria and 14 Macroplastique® urethral exposures were identified. The median age at first presentation was 73.5 years (IQR57.5-79.7 years) with 48 months (IQR 22-78 months) as the median time to first presentation after last Macroplastique® injection. The median number of injection sessions was 2 (IQR 1-2.75 sessions) with a medium volume of 4.5 ml (IQR 2.75-9.0 ml). Presenting symptoms included urge incontinence (64.3%), stress urinary incontinence (57.1%), recurrent urinary tract infection (42.9%), urinary urgency (28.9%), urinary frequency (28.9%), urinary retention (14.3%), and interrupted flow (7.1%). Macroplastique® urethral exposures were extracted in 10 patients using blunt, sharp, or electrocautery excision. No complications after excision were identified and improvement in urinary symptoms was observed.
Urethral bulking with Macroplastique® can lead to symptomatic urethral exposures.
International urogynecology journal. 2021 Jul 02 [Epub ahead of print]
Laura Ramirez-Caban, Maral Malekzadeh, David A Ossin, Eric A Hurtado
Department of Gynecology, Cleveland Clinic Florida, 2950 Cleveland Clinic Blvd, Weston, FL, 33331, USA. ., Department of Gynecology, Cleveland Clinic Florida, 2950 Cleveland Clinic Blvd, Weston, FL, 33331, USA., Department of Urology, University of Texas Health Science San Antonio, 7703 Floyd Curl Drive, Mail Code 7845, San Antonio, TX, 78229-3900, USA.