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New England Section of the American Urological Association

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Surgical Management of Urethral Bulking Agent Complications in Women
Michael E. Goltzman, MD1, Richard T. Kershen, MD2.
1UConn Health, Farmington, CT, 2Tallwood Institute of Urology, Hartford Healthcare Medical Group, Hartford, CT.

BACKGROUND Urethral bulking agent (UBA) injection serves as a quick, minimally invasive method for the treatment of stress urinary incontinence (SUI) in women. When injected submucosally these agents restore continence via urethral coaptation. Though bovine collagen (Contigen™) served as the predominant injectable agent for years, a variety of synthetic agents including Macroplastique®, Durasphere® and Coaptite® have risen to prominence. Though widely utilized, there is only sparse data in the literature regarding potential complications of these agents. In this case series, we describe UBA complications in four patients requiring surgical management as well as the techniques utilized to resolve these complications.
METHODS This study entails a retrospective review of four patients presenting for evaluation and management of complications related to injection of UBAs to a single surgeon between 2016 and 2020. Presenting symptoms, diagnostic evaluation, surgical management and outcomes are reviewed. The presenting symptoms were described as either early-onset (< 12 mo) or late-onset (> 12 mo) according to first report.

TABLE 1: Case Series of Patients with Bulking Agent Complications
Patient #Injectable AgentPresenting SymptomsTiming of Presenting SymptomsTime from Bulking Agent to DiagnosisManagement
1Collagen®Dysuria, Urgency, Vaginal pain, DyspareuniaEarly-Onset2 YearsTransvaginal Open Excision
2Macroplastique®Pelvic pain, Vaginal pain, DyspareuniaLate-Onset7 YearsTransvaginal Open Excision
3Macroplastique®Intermittency, Urgency, NocturiaEarly-Onset4 YearsTransurethral Resection**
4Coaptite®Recurrent UTIs, Frequency, Urge incontinenceEarly-OnsetUnknownN/A**
**Awaiting Transvaginal Open Excision

RESULTS Patient characteristics and management strategies are presented in Table 1. The most common presenting symptoms included urinary urgency, vaginal pain and dyspareunia. In most cases, voiding dysfunction occurred early after the bulking therapy. In all cases, cystourethroscopy identified agent erosion or local inflammatory response (Figure 1); imaging was performed in 3 cases (1 MRI, 2 CT). To date, transvaginal excision has been performed in two patients, with two patients awaiting definitive operation. Patients undergoing transvaginal excision presented with vaginal pain and necessitated urethral reconstruction (Figure 2). Open excision of the UBA resulted in improvement or complete cure of symptoms. Both patients developed recurrent SUI, with one patient requiring a salvage pubovaginal sling procedure to date.

CONCLUSION The majority of UBA complications, including urinary tract infection, hematuria, and urinary retention are considered mild and transient and may be managed with non-surgical interventions.1 For patients in whom conservative management fails or for more severe complications (i.e. erosion, abscess, palpable mass and chronic pain) transurethral or transvaginal excision of bulking agent and associated granulomas should be considered. Though open excision is a major surgical endeavor, complete relief of symptoms can be achieved, albeit with a risk of de-novo SUI. Physicians should have a high level of suspicion for bulking agent erosion or granuloma development in all patients with a history of prior injection presenting with lower urinary tract symptoms and/or pain.
1De Vries AM, Wadhwa H, Huang J, Farag F, Heesakkers JPFA, Kocjancic E. Complications of Urethral Bulking Agents for Stress Urinary Incontinence: An Extensive Review Including Case Reports. Female Pelvic Med Reconstr Surg. 2018;24(6):392-398.

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