Management of complications in use of urethral bulking agents in women for stress urinary incontinence – a meta-analysis

Islam, Majdee., Wadhwa, Harpreet.,  Dobbs, Ryan., and Kocjancic, Ervin. (2015). NOMCC: 214, PD28-04.

Introduction and Objectives: Stress urinary incontinence (SUI) is a common condition that adversely impacts the quality of life in effected women. Periurethral injection of urethral bulking agents (UBA) is considered a simple and cost effective treatment of SUI for these women. This meta-analysis critically assesses the safety of the seven most commonly used UBA, along with the management of reported complications. 

Methods :

Using PubMed, Scopus and Ovid Medline, a meta-analysis of the scientific literature from 1996 to July 2014 was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statements to quantitatively summarize the complications and reported treatments of urethral bulking agents. Initially, 1022 studies were identified and evaluated for relevancy and redundancy (Figure 1). Abstracts were excluded. A total of 4,326 patients from eligible 78 study samples were analyzed. Complication incidence was recorded, along with treatment and efficacy. Statistical analysis of complication incidence and type between UBAs was performed. 

Results:

1,999 complications were reported in the 78 studies that were analyzed. Of the reported complications, 3.8% were considered major (Clavien III); of which 70.6% required incision and drainage (I&D) and 29.3% required more invasive procedures. The incidence of major UBA complications for Durasphere was 9.4%, Coaptite was 7.4%, Ziudex was 17.8%, Bulkamid was 0.8%, Contigen was 1.8%, and Tegress was 5.9%. Macroplastique had no serious complications reported. Odds ratio (OR) of any UBA complication compared to control (Contigen) was 4.8 with p<0.0001, and OR of major complication was 58.4 with p=0.0042. 

Conclusions: Although all urethral bulking agents are associated with complications, some are more prone to major complications than others. Most urethral bulking agent complications are transient and/or do not require treatment. Of the major complications, almost 71% were treated by I&D. For major complications, Macroplastique is the only UBA with a superior safety profile as compared to Contigen.