Durability, safety and efficacy of polyacrylamide hydrogel (Bulkamid®) in the management of stress and mixed urinary incontinence: three year follow up outcomes

Abstract

IntroductionThere are a myriad of treatment options available for patients suffering with the increasingly prevalent condition of stress urinary incontinence (SUI). The minimally invasive nature of periurethral bulking agents makes them an attractive proposition in the correctly selected patient. There is, however, limited data available on the medium to long term safety and efficacy of this procedure. The aim of our study is to evaluate the outcomes of Polyacrylamide Hydrogel (PAHG) (Bulkamid®) as a periurethral bulking agent at our institution.Material and methodsFrom 2006 to 2011, two hundred and fifty six women underwent periurethral bulking with PAHG in the management of SUI or mixed urinary incontinence (MUI). Women were assessed with at least yearly quality of life and ICIQ questionnaires.ResultsThe majority of patients had the procedure under a local anaesthetic, with a median operative time of 9 minutes. Median follow up was 38 months. 82% of patients reported cure/significant improvement at 3 months. Importantly, this high satisfaction rate was maintained at final follow up and was reflected in both VAS and ICIQ scores. There were no reported adverse reactions and no significant safety concerns.ConclusionsWe conclude that Bulkamid® injection is an efficacious, minimally invasive, and safe procedure for a selected group of patients with stress incontinence. In our study, PAHG has been shown to be durable and safe.

Bulkamid (PAHG) in mixed urinary incontinence: What is the outcome?

“…Bulking therapy is simple, safe, and shows both objective and subjective improvement and relief in selected SUI patients [ 10 ]. Although a Cochrane Review concluded that evidence for urethral injection therapy to treat UI in women remains insufficient to guide practice [ 18 ], the minimally invasive nature, efficacy, and safety of periurethral bulking with PAHG favors its use in the correctly selected patient [ 19,20,21 ].…”

Reconstruction of Urethral Sphincter With Polyacrylamide Hydrogel

“…22 Three studies present shorter follow-up data of standard PAHG injection with a timeline similar to our study. 20,21,23 However, comparison continues to be limited by differing definitions of subjective and objective outcomes, methods of data collection, and varying sample sizes. Pai et al 23 offer a retrospective study of 212 women and report 82.8% subjective improvement (defined as subjective cure or significant improvement) at 3-month follow, which was stable over the 5-year study.…”

Hydrogels for Tissue Engineering: Addressing Key Design Needs Toward Clinical Translation

“…Bulkamid ® is an injectable synthetic polyacrylamide hydrogel approved by the FDA for use in the United States in 2020 to treat stress urinary incontinence (SUI) by functioning as a bulking agent to add a total volume of up to 2 ml to the walls of the urethra ( U.S. Food and Drug Administration, 2021 ; Kasi et al, 2016 ). In vitro and in vivo studies investigated the cytotoxicity ( McCollister et al, 1965 ) and degradation ( Caulfield et al, 2002 ) of polyacrylamide, informing the choice of the 2.5% (w/v) polyacrylamide concentration that was confirmed via multiple long-term clinical studies to be suitable in the targeted application ( Lose et al, 2010 ; Pai and Al-Singary, 2015 ; Kasi et al, 2016 ). Although polyacrylamide was not previously approved for clinical use by the FDA, it had been in clinically used for breast augmentation in China since 1997 and years earlier in Ukraine ( Margolis et al, 2015 ), albeit with reports of multiple adverse complications such as lumps, breast pain and induration, and in certain cases a foreign body response which destroyed the structure of adjacent muscle and gland ( Qiao et al, 2005 ).…”