The UroLume endoprosthesis and UroLume cripple syndrome: a systematic review and meta-analysis of pathophysiology, complications, surgical management, psychological burden, and epidemiology of surviving patients worldwide.

BACKGROUND

The UroLume endoprosthesis (AMS/Endo-care), commercially available 1988-2007 and FDA-approved in 1996, was positioned as a permanent minimally invasive solution for recurrent bulbar urethral stricture and benign prostatic hyperplasia. Despite early procedural success, long-term data revealed a severe complication profile-including irreversible urethral destruction, spongiofibrosis, MDR infections, chronic kidney disease, and significant psychological morbidity-culminating in a clinical entity described here under an author-proposed conceptual framework termed 'UroLume Cripple Syndrome'.

OBJECTIVES

To synthesise four decades of evidence on UroLume pathophysiology, complications, surgical management hierarchy, psychological burden, and cumulative multimorbidity; to perform a pooled meta-analysis of primary complication endpoints; and to present an original epidemiological model estimating surviving patients globally and in Greece in 2026.

METHODS

PRISMA 2020-compliant systematic review and meta-analysis. Databases searched: PubMed, Embase, Cochrane Library (inception to March 2026).

INCLUSION: peer-reviewed studies of UroLume implantation, explantation, or post-UroLume reconstruction; minimum 12-month follow-up; series n ≥ 10. Study quality assessed using the Newcastle-Ottawa Scale (NOS). Random-effects meta-analysis (DerSimonian-Laird estimator) performed for three primary complication endpoints across all 43 included studies. PROSPERO registration submitted; number pending.

RESULTS

Forty-three studies met inclusion criteria (n = 3847 patients). Pooled meta-analysis (n = 2730 in quantitative pool): restenosis/tissue ingrowth 37.9% (95% CI 36.1-39.8%, I2 = 0%); stent explantation 8.7% (95% CI 7.7-9.8%, I2 = 0%); urinary incontinence 9.7% (95% CI 8.7-10.9%, I2 = 0%). Complete epithelialisation, irreversible after 12 months, affects approximately 8-13% of long-term survivors. A six-filter epidemiological model provides a hypothesis-generating estimate of fewer than 100 clinically active patients globally exhibiting this severe profile.

CONCLUSIONS

The proposed framework of UroLume Cripple Syndrome conceptualizes a complex iatrogenic condition with distinct pathophysiological, reconstructive, and psychological dimensions. Specialized published institutional pathways remain confined to fewer than 10 centers worldwide, highlighting the need for structured registry creation and guideline consensus to support this legacy cohort.