Effectiveness of Multimodal Therapy for Urinary Incontinence in Pediatric Spina Bifida (MMICIUISP)

Cairo University (CU)

Status: Completed

Conditions: Myelomeningocele Spina Bifida

Treatments: Other: Diet and Toileting Education; Other: Abdominal Strengthening Program.; Other: Interferential Current Therapy; Other: Osteopathy Protocol; Other: Biofeedback Training Procedure.; Other: Pelvic Floor Physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07338799

IRB00014233-56

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 66 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• = children with lower lumbar or sacral myelomeningocele spina bifida,
• urinary incontinence due to neurogenic bladder dysfunction
• the ability to understand and adhere to study procedures
• :intelligence required to be engaged in biofeedback and behavioural training activities

Exclusion Criteria

• thoracic or high lumbar myelomeningocele, and other forms of spina bifida with complete sacral loss of innervation
• severe cognitive or behavioral impairments likely to interfere with adherence to training regimens
• uncontrolled epilepsy and severe musculoskeletal deformities that could not allow the placement of the electrode or postural exercises.
• The participants that had undergone urological or neurosurgical operation in the past six months and those who were undergoing botulinum toxin injection or sacral neuromodulation therapy were also disqualified

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

66 participants in 2 patient groups

Group A

Experimental group

Description:

1\. Diet and Toileting Education The implementation of the intervention was based on behavioral interventions, including diet and toileting education. In the first session, both children and their caregivers were provided with personalized counseling on the need to balance the intake of fluids and dietary fiber within the age specifications. The guidelines recommended that people always should take fruits, vegetables, and whole grains and avoid constipating foods like high dairy and refined carbohydrates. children were taught to promote regular toileting routines especially planned toileting which lasts about ten minutes after meals with foot support to enhance the pelvis positioning and defecation dynamics. Reward chart system was implemented to strengthen the adherence and promote good toileting behaviors. This was followed by weekly reinforcement sessions before to check the progress, dietary questions and modify recommendations. Adherence was monitored by using caregiver diaries

Treatment:

Other: Pelvic Floor Physiotherapy

Other: Biofeedback Training Procedure.

Other: Osteopathy Protocol

Other: Interferential Current Therapy

Other: Abdominal Strengthening Program.

Other: Diet and Toileting Education

Group B

Active Comparator group

Description:

Pelvic Floor Physiotherapy Certified pediatric physiotherapists administered pelvic floor muscle (PFM) physiotherapy, twice a week, during 8 weeks. Every session started with an education on the anatomy and physiology of the bladder and pelvic floor with focus on the normal voiding patterns and how relaxation and contraction are used to manage continence. The first sessions aimed at down-training the maladaptive voiding postures with visual and tangible feedback to correct the maladaptive posture and enhance awareness. Environmental training was active training that comprised of blow-out-candle breathing exercises to coordinate the abdominal push with pelvic-floor relaxation by three sets of 8 -12 reps which were practiced both morning and evening at home. Surface EMG biofeedback was used, in 8 sessions of supervision to give a visual representation of muscle control and involvement. The participants were advised to keep exercise records and were given parental coaching

Treatment:

Other: Pelvic Floor Physiotherapy

Other: Diet and Toileting Education