Hypothesis / aims of study
Addressing the underlying voiding dysfunction in pediatric patients with vesicoureteral reflux, can lead to significant improvements in reflux resolution and overall urinary health. The aim of our study is to assess the therapeutic and quality of life-related outcomes of concurrent Deflux® and Botulinum Toxin Type A administration in vesicoureteral reflux pediatric patients with refractory non-neurogenic dysfunctional voiding.
Study design, materials and methods
This study was a prospective cohort with a minimum follow-up period of six months post-surgery. Patients aged 4-18 years with vesicoureteral reflux eligible for surgical intervention, evidence of an interrupted or fractional voiding pattern on uroflowmetry studies combined with active pelvic floor electromyography during the voiding phase, and refractory to pelvic floor biofeedback and medical treatments were included in the study. Patients with neurogenic bladder, concurrent congenital anomalies of the genitourinary tract, or a failure to comply with follow-up evaluations were excluded. All cases were evaluated both pre- and post-operation by ultrasonography, micturating cystogram, uroflowmetry, and electromyography. Comprehensive quality of life-related outcomes were assessed using the Pediatric Incontinence Questionnaire (PinQ) in combination with the Dysfunctional Voiding Scoring System (DVSS) and ROME IV criteria. Surgical management for all cases was performed with concurrent administration of Deflux® and Botulinum Toxin Type A. The hydrodistension implantation technique, combined with autologous blood injection, was employed as the Deflux® injection method using rigid cystoscopy. Botulinum Toxin Type A injection was administered in the periurethral region, perineal body, and the peri-anal area (at the 3 and 9 O’clock positions). Statistical analyses were performed using R Statistical software (v4.4.2; R Core Team 2021), with a significance threshold of p <0.05.
Results
29 female patients were included in our study. The mean age was 7.09 ± 2.07 years. 13 (44.82%) patients had bilateral vesicoureteral reflux, resulting in a total of 41 refluxing renal units. Of these, 1 (2.43%) unit had grade I reflux, 5 (12.19%) units had grade Ⅱ, 18 (43.9%) units had grade Ⅲ, 15 (36.58%) units had grade IV, and 2 (4.87%) units had grade V reflux.
There were no reports of post-operative complications of urinary retention or other respiratory-related side effects during the follow-up period.; however, 3 (10.34 %) cases experienced urinary incontinence with an average duration of 0.13 ± 0.44 weeks, which self-resolved without any intervention. There were no reports of fecal incontinence in patients receiving peri-anal Botulinum Toxin Type A injections. Six months post-operatively, micturating cystograms indicated vesicoureteral reflux resolution in 36 (87.8%) units, severity improvement in 2 (4.87%) units, and no change in severity in 3 (7.31%) units. Additionally, there was a significant difference between the pre-operative (13.58 ± 3.68) and post-operative (5.27 ± 2.98) DVSS (p<0.001), which is in align with the significant difference presented in the pre-operative (20.62 ± 8.62) vs post-operative (11.55 ± 7) PinQ findings (p<0.001).
Interpretation of results
The study results indicate a significant improvement in post-operative DVSS. The observed reduction in dysfunctional voiding severity may contribute to the alleviation of fractional voiding patterns observed in uroflowmetry, leading to near-normal voiding patterns, as demonstrated in the Austin et al. study [1]. This improvement in voiding patterns can positively alter quality of life-related outcomes. In our study, this was evidenced by a significant post-operative reduction in PinQ, consistent with DVSS findings.