Effectiveness of Multimodal Therapy Including Biofeedback, Osteopathic Procedures, Behavioral Training, Diet Control, and Electrical Stimulation in the Management of Urinary Incontinence in Children With Lumbar or Sacral Myelomeningocele Spina Bifida: A Randomized Controlled Trial
Effectiveness of Multimodal Therapy Including Biofeedback, Osteopathic Procedures, Behavioral Training, Diet Control, and Electrical Stimulation in the Management of Urinary Incontinence in Children With Lumbar or Sacral Myelomeningocele Spina Bifida: A Randomized Controlled Trial
Background: Overactive bladder and urinary incontinence in children have significant influence on psychosocial well-being and quality of life. The current study compared the effectiveness of the Multimodal Intervention (MMI) protocol to a Conventional Intervention (CI) in increasing urinary control, pelvic floor functioning, and quality of life. 66 adolescents (10-17 years old) were randomly divided into MMI (n=33) and CI (n=33) groups according to the inclusion criteria related to urinary incontinence. A 10-week therapeutic regime was given to every group with a 12-week post-treatment follow-up period. The key outcome measures were the number of urinary incontinence episodes per day, pelvic floor muscle electromyography (EMG) values, voiding frequency, Pediatric Quality of Life Inventory (PedsQL) items, and Pediatric Incontinence Questionnaire (PINQ) items.
Study Design The current study was designed as a randomized, controlled, parallel-group clinical trial between May 2024 and August 2025. The definitive aim of the study was to evaluate the efficacy of a multimodal rehabilitation program; biofeedback training, osteopathic treatment, behavioral modification, dietary control, and interferential current therapy, in urinary incontinence of pediatric patients with lumbar or sacral myelomeningocele spina bifida. The participants were randomly assigned using a computer-generated randomization list of two equal groups of participants. Group A was exposed to the multimodal intervention and group B to the conventional physiotherapeutic intervention based on the pelvic-floor muscle training and educative program. The concealment of allocation was carefully maintained by use of sequentially numbered, opaque and sealed envelopes which were under the care of an independent researcher who did not take part in the process of data acquisition and data analysis.
The study was conducted in the same strict spirit as the principles of ethics as outlined in the Declaration of Helsinki and the institutional ethics committee gave its consent to the research. Written informed consent was presented to parents or legal guardians before the enrolment, and verbal consent was elicited among the children themselves. Blinding was preserved to the level of outcome assessors and statisticians who were not aware of the group assignments during the intervention and the analytical stage.
All participants were thoroughly assessed at the baseline before the intervention and then at the end of the 10-week programmed and 12 weeks later assessed as a follow up. The main outcome measure was the improvement of urinary continuance, measured by the number of the incontinence incidences and thorough analysis of the bladder diaries. The secondary outcomes included pelvic-floor muscle strength (EMG biofeedback measure), voiding behavior and quality of life, measured using the PINQ and the PedsQL. The intervention sessions were conducted in a limited clinical environment through certified pediatric physiotherapists and osteopathic practitioners. All the data were pseudonymized and analyzed accordingly with proper statistical tests to explain within and between group differences.
Inclusion Criteria:
Exclusion Criteria