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Complications of Urethral Bulking Agents for Stress Urinary Incontinence

An Extensive Review Including Case Reports

de Vries, Allert M., MD*; Wadhwa, Harpreet, MD; Huang, Jason, MD; Farag, Fawzy, MD, PhD; Heesakkers, John P.F.A., MD, PhD*; Kocjancic, Ervin, MD

Female Pelvic Medicine & Reconstructive Surgery: November/December 2018 - Volume 24 - Issue 6 - p 392–398
doi: 10.1097/SPV.0000000000000495
Review Article

Objectives Stress urinary incontinence in women is a common problem that significantly impacts quality of life. Periurethral injection of urethral bulking agents (UBAs) is a simple, noninvasive, and cost-effective treatment. However, complications associated with UBA are often underappreciated. Objective of this review was to get a complete overview of all published complications of UBA.

Methods An extensive search of the scientific literature was conducted to quantitatively summarize the complications and their treatments of 8 UBAs. A total of 117 articles (original articles and case reports) were included in the final analysis. Complication incidence, treatment incidence, and follow-up time were extracted when mentioned. Statistical analysis of complication incidence of each UBA was calculated if possible.

Results A total of 2095 complications in 6462 treated patients were reported in 79 studies. Sixty-seven (3%) were considered serious implying operative correction (Clavien grade III); of these, 46 (69%) required incision and drainage, and 21 (31%) required a more invasive procedure. In 38 case reports and small case series, 49 patients were treated for 110 complications. Of these 110 complications, 41 (37%) can be classified as Clavien grade III.

Conclusions This extensive review shows that various UBAs have different complication rates, with certain UBAs being more prone to serious complications. Based on available publications, most UBAs have a good safety profile, with low complication rates. However, although the majority of UBA complications are transient and require no or noninvasive treatment, serious complications may require invasive intervention and treatment.

This article extensively summarizes the complications of urethral bulking agents published in literature.

From the *Department of Urology, Radboud University Medical Centre, Nijmegen, the Netherlands;

Department of Urology, University of Illinois, Chicago, IL;

Department of Urology, Sohag University Hospital, Sohag, Egypt.

Correspondence: Allert M. de Vries, MD, Department of Urology, Radboud University Medical Centre, PO Box 9101, 6500 HB Nijmegen, the Netherlands. E-mail: allert.devries@radboudumc.nl.

Author contributions: A.M.d.V.: data collection, data analysis, manuscript writing, project development. H.W.: project development, manuscript writing. J. Huang: data collection, data analysis, manuscript writing.F.F.: data collection, editing. J. Heesakkers: project development, editing. E.K.: project development, editing.

Preliminary data of this study were presented at ICS 2015 (abstract #510) on October 9, 2015, in Montreal, Quebec, Canada.

A.M.d.V. has received an unrestricted research grant from Urogyn BV, Nijmegen, the Netherlands; has family ties with shareholders in Urogyn BV; and received a travel grant from Astellas. J. Heesakkers reports honoraria from Astellas, Pierre Fabré, Boston Scientific, and Allergan and is a consultant to Actis. E.K. reports honoraria from Astellas, Boston Scientific, Coloplast, and Medtronic. H.W., J. Huang, and F.F. have declared they have no conflicts of interest.

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