A novel non-invasive technique for pediatric phimosis treatment: assessing efficacy and post-treatment family care — a retrospective cohort study

BACKGROUND: The European Association of Urology 2024-2025 guidelines recommend conservative management as first-line therapy for pediatric phimosis before considering surgical intervention. Balloon catheter dilation treatment (BCDT) has emerged as a promising foreskin-preserving approach, yet high-quality comparative evidence against conventional circumcision (CC) remains limited. This study aimed to compare the clinical efficacy, safety outcomes, and family-centered measures between BCDT and CC in a pediatric cohort. METHODS: This retrospective cohort study enrolled 200 boys (aged 2-12 years) with Kikiros grade ≥ 2 phimosis treated between January and December 2024 at a tertiary pediatric surgery center. Patients were allocated to BCDT (n = 100) or CC (n = 100) groups based on treatment received. Primary outcomes included cure rates (Kikiros grade 0-1) at 6 months. Secondary outcomes encompassed procedure-related parameters, complication rates, pain assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) scale, healing time, parent-reported satisfaction, and health literacy-associated compliance measures. Propensity score analysis confirmed baseline comparability. Number needed to treat (NNT) and effect sizes (Cohen's d) were calculated to quantify clinical significance. RESULTS: Both treatments achieved high 6-month cure rates (BCDT: 98.0% vs. CC: 100.0%; P = 0.497; absolute risk difference: 2.0%, 95% CI: -0.7% to 4.7%). BCDT demonstrated substantial advantages in procedure efficiency (mean operative time: 5.03 ± 0.62 vs. 29.38 ± 6.69 min; P < 0.001; Cohen's d=-5.13) and recovery parameters (healing time: 6.74 ± 2.13 vs. 15.90 ± 3.06 days; P < 0.001; Cohen's d=-3.47). Pain-related outcomes significantly favored BCDT: lower incidence (65.0% vs. 99.0%; P < 0.001; NNT = 3), shorter duration (21.2 ± 14.0 vs. 93.2 ± 55.6 h; P < 0.001), and reduced FLACC scores at 24 h (2.59 ± 1.44 vs. 5.22 ± 2.07; P < 0.001; Cohen's d=-1.48). Edema occurrence was substantially lower in the BCDT group (60.0% vs. 100.0%; P < 0.001; NNT = 2.5). Parent satisfaction rates (score 5, very satisfied) were 96.0% and 88.0% for BCDT and CC, respectively (P = 0.068). Parent health literacy (Newest Vital Sign score) positively correlated with home care compliance (r = 0.42; P < 0.001), with adequate literacy (NVS ≥ 4) associated with significantly better adherence (3.21 ± 0.58 vs. 2.74 ± 0.71; P < 0.001). CONCLUSIONS: In this retrospective cohort, BCDT achieved short-term (6-month) cure rates non-inferior to CC while offering clinically meaningful advantages in procedural simplicity (6-fold reduction in operative time), pain mitigation (34% absolute reduction in incidence), accelerated healing (2.4-fold faster), and enhanced parent satisfaction. As a foreskin-preserving, minimally invasive option requiring only topical anaesthesia, BCDT may be considered for carefully selected symptomatic children with pathological phimosis, within a stepwise conservative management strategy that includes watchful waiting and topical corticosteroids as first-line therapy. Routine intervention for asymptomatic physiological phimosis is not supported by these data, and durable cure, long-term recurrence prevention, and broad first-line adoption require confirmation in prospectively designed studies with follow-up extending beyond puberty. Outcomes are optimised when supported by adequate parent health literacy for post-procedure home-care adherence.