Durasphere® EXP: a non-biodegradable agent for treatment of primary Vesico-Ureteral reflux in children

Abstract

Introduction:Durasphere® EXP (DEXP) is a compound of biocompatible and non--biodegradable particles of zirconium oxide covered with pyrolytic carbon. The aim of this study is to evaluate the durability of off-label use of DEXP in the treatment of primary vesicoureteral reflux in children.Materials and Methods:Patients who underwent subureteric injection of DEXP for the correction of primary VUR were retrospectively reviewed. Patients aged >18 years as well as those who had grade-I or -V VUR, anatomic abnormalities (duplicated system, hutch diverticulum), neurogenic bladder or treatment refractory voiding dysfunction were excluded. Radiologic success was defined as the resolution of VUR at the 3rd month control. Success was radiographically evaluated at the end of the first year.Results:Thirty-eight patients (9 boys, 29 girls; mean age, 6.3±2.7 years) formed the study cohort. Forty-six renal units received DEXP (grade II: 22; grade III: 18; grade IV: 6). Mean volume per ureteric orifice to obtain the mound was 0.70±0.16mL. First con- trol VCUG was done after 3 months in all patients. After the first VCUG, 6 patients had VUR recurrence. Short-term radiologic success of DEXP was 84.2%. Rate of radiologic success at the end of the first year was 69.4% (25/32). Lower age (p:0.006) and lower amount of injected material (p:0.05) were associated with higher success rates at the end of 1 year.Conclusion:This is the first study to assess the outcomes of DEXP for treatment of primary VUR in children. After 1 year of follow-up, DEXP had a 69.4% success rate.

Carbon Coated Beads and Dextranomer/Hyaluronic Acid Copolymer in the Treatment of Primary Vesicoureteral Reflux of Female Adults

“…Dolayısıyla uygulama sırasında diğer enjeksiyon materyallerine kıyasla daha hızlı hareket edilmelidir, ki bu durum, diğer araştırmacılar tarafından da rapor edilmiştir. 27 Bugüne kadar Durasphere ® in subüreterik kullanımı ile ilgili olarak literatürde yalnızca iki çalışma yer almaktadır. İlk çalışmada araştırmacılar, transplante böbreklerde güvenli olduğunu bildirmişlerdir.…”

“…28 Ülkemizde yapılmış olan ikinci çalışmada ise Özkuvancı ve ark., çocuklarda da başarı ve güvenle kullanılabileceğini rapor etmişlerdir. 27…”

Long-term complications of bulking agents in the treatment of stress urinary incontinence: Results of a national survey

“…Subsequently, Durasphere was replaced under the same trade name with smaller sized particles. 28 A study on Durasphere for the treatment of gastroesophageal reflux disease showed no ulceration, no migration, no degradability of bulking agent at 12 months post-procedure 29 ; however, a study focussed on UI with Durasphere reported migration of material into local and distant lymph nodes, as well as the urethral mucosa, at 6 months follow-up. 30 In addition, a follow-up study on 135 female patients who had been injected with Durasphere found the formation of a periurethral mass in four (2.96%) patients following investigation of voiding symptoms and pelvic pain, 12-18 months post-procedure.…”

“…Durasphere has been described as 'pyrolytic' by manufacturers. 28 In addition, Zuidex has been described as 'biocompatible, non-immunogenic, highly viscous and biodegrades slowly by hydrolysis' -due to this Zuidex has been categorised as an active agent. 41 Bulkamid generally has a better safety profile than Macroplastique.…”

Brazilian consensus on vesicoureteral reflux–recommendations for clinical practice

“…Pyrolytic Carbon (Durasphere®): Its application is difficult and there are few studies showing its effectiveness (94).…”