Deflux and Botulinum Toxin Type A as Combined Therapeutic Approach in Pediatric Vesicoureteral Reflux and Concurrent Non‐Neurogenic Dysfunctional Voiding: Insights From a Prospective Single‐Arm Study

PURPOSE: We aimed to assess uroflowmetric measurements and quality-of-life outcomes following synchronous Deflux injection and pelvic floor and inter-sphincteric Botulinum toxin type A (BTX-A) injection in pediatric patients diagnosed with vesicoureteral reflux (VUR) and non-neurogenic dysfunctional voiding (NNDV) at 6-month and 1-year follow-ups. METHODS: This prospective study included female children aged 5-18 years with concurrent VUR and NNDV. All participants underwent pre-and postoperative ultrasonography, uroflowmetry study and quality-of-life assessment. Deflux injection was performed using the hydrodistension implantation technique in the refluxing ureter. BTX-A injection was administered to the periurethral and perineal body areas. Participants with functional constipation, confirmed by ROME Ⅳ criteria, received perianal BTX-A injection. All statistical analyses were conducted using R Statistical software (version 4.4.2), with a significance threshold set at p < 0.05. RESULTS: Among 30 patients, near bell-shaped voiding patterns were observed in 23 (76.7%) at 6-month and 27 (90%) at 1-year follow-ups with a significant overall change across three assessment timepoints (LR = 37.47, p < 0.001). Complete VUR resolution was observed in 40 of 46 (87%) refluxing renal units at 6 months (p < 0.001). Volume-adjusted maximal and average flow indices improved significantly over time (p = 0.003 and p < 0.001, respectively). PinQ scores decreased from 20.83 ± 8.55 preoperatively to 11.26 ± 6.91 at 1-year follow-up (p < 0.001). CONCLUSION: This prospective study indicated that the combined BTX-A and Deflux injections were associated with improvements in dysfunctional voiding severity, voiding flow parameters, voiding diaries, and quality-of-life outcomes in children with concurrent NNDV and VUR.