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Impact of Adjunctive Myo-Inositol and Magnesium Therapy on Paediatric Overactive Bladder: A Retrospective Analysis
Alessandro Colletti1, Michele Favro2, Luciano Sangiorgio3
1Department of Pharmaceutical Science and Technology, University of Turin, 10125 Turin, Italy.
Insights
Adjunctive nutraceuticals improved overactive bladder (OAB) symptoms in children when added to oxybutynin, showing benefits in secondary outcomes and tolerability. Further trials are needed to confirm these findings for pediatric OAB management.
Area of Science:
- Pediatric Urology
- Pharmacology
- Nutraceuticals
Background:
- Overactive bladder (OAB) significantly impacts children's quality of life, with current treatments like oxybutynin often showing incomplete efficacy.
- Emerging research suggests targeting metabolic dysfunction and oxidative stress may benefit OAB treatment.
- This study investigates a nutraceutical formulation (myo-inositol, magnesium, folic acid, vitamin C) as an adjunct to oxybutynin in pediatric OAB.
Purpose of the Study:
- To evaluate the clinical impact of an adjunctive nutraceutical formulation (LEVIGON™ PRO) in children with OAB receiving oxybutynin.
- To assess the efficacy and tolerability of combination therapy versus oxybutynin alone.
- To explore potential benefits in children with impaired fasting glucose (IFG).
Main Methods:
- Retrospective review of 120 children (5-15 years) with OAB, divided into two groups: oxybutynin + LEVIGON™ PRO (Group A) and oxybutynin alone (Group B).
- Primary outcome: complete daytime urinary continence at Day 112.
- Secondary outcomes: incontinence episodes, voiding frequency, bladder wall thickness, uroflowmetry, and PPBC scores; exploratory IFG subgroup analysis.
Main Results:
- While the primary endpoint of complete daytime continence did not reach statistical significance (61.7% vs 48.3%, p=0.14), Group A showed significant longitudinal improvements in secondary outcomes (p<0.05).
- Combination therapy led to greater reductions in incontinence episodes, voiding frequency, and PPBC scores, alongside increased mean voided volume and reduced bladder wall thickness.
- The IFG subgroup in Group A exhibited significant reductions in fasting glucose, insulin, and HOMA-IR (p<0.01); both treatments were well-tolerated.
Conclusions:
- Adjunctive nutraceutical therapy with oxybutynin demonstrated greater improvements in key secondary outcomes for pediatric OAB, with a favorable safety profile.
- The primary endpoint's lack of statistical significance, coupled with positive secondary outcomes, suggests a potential additive benefit requiring further investigation.
- Findings are hypothesis-generating due to the retrospective design, necessitating confirmation through prospective randomized controlled trials.
Background:
Overactive bladder (OAB) is a common functional disorder in paediatric populations and is associated with significant psychological burden and impaired quality of life. Although oxybutynin is widely used as first-line pharmacological therapy, a substantial proportion of children exhibit incomplete symptom control or limited tolerability. Emerging evidence suggests that targeting metabolic dysfunction, oxidative stress, and neuromuscular excitability may provide additional therapeutic benefit. This retrospective observational study evaluated the clinical impact of an adjunctive nutraceutical formulation containing myo-inositol, microlipodispersed magnesium, folic acid, and vitamin C (LEVIGON™ PRO, Sanitpharma; Milan, Italy) in children with OAB receiving oxybutynin.
Methods:
Medical records of children diagnosed with OAB were retrospectively reviewed. After applying inclusion and exclusion criteria, 120 patients aged 5-15 years were included and allocated to two groups based on documented treatment: oxybutynin plus LEVIGON™ PRO (Group A, n = 60) or oxybutynin alone (Group B, n = 60). The primary outcome was complete daytime urinary continence at Day 112. Secondary outcomes included weekly incontinence episodes, voiding frequency, bladder wall thickness, uroflowmetry parameters, and Patient Perception of Bladder Condition (PPBC) scores. An exploratory subgroup analysis was performed in 34 children with impaired fasting glucose (ifg), assessing fasting glucose, insulin, and homa-ir.
Results:
by day 112, complete daytime continence was achieved in 61.7% of patients in group a and 48.3% in group b (absolute risk difference 13.4%; nnt ≈ 7.5; p = 0.14). across secondary endpoints, the combination therapy group showed significantly greater longitudinal improvements (group × time interaction, p < 0.05), including reductions in weekly incontinence episodes, voiding frequency, post-void residual volume, and ppbc scores, as well as increases in mean voided volume, qmax, and reductions in bladder wall thickness. in the ifg subgroup, greater reductions in fasting glucose, fasting insulin, and homa-ir were observed in group a compared with group b (p < 0.01). Both treatments were well tolerated, with no serious adverse events reported.
Conclusions:
adjunctive nutraceutical therapy combined with oxybutynin was associated with greater improvements in several clinically relevant secondary outcomes in children with OAB, with a favourable tolerability profile. Although the primary endpoint did not reach statistical significance, the overall pattern of findings may suggest a possible additive benefit; however, these findings may be influenced by residual confounding inherent to the retrospective observational design. Therefore, the results should be considered hypothesis generating and require confirmation in prospective randomized controlled trials.
