Effectiveness of Multimodal Therapy for Urinary Incontinence in Pediatric Spina Bifida

NCT07338799 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-04-01

No results posted yet for this study

Summary

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.

Conditions

  • Myelomeningocele Spina Bifida
  • Spina Bifida, Open

Interventions

OTHER

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 and or

OTHER

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 so that they were practicing at home. Adhe

OTHER

Abdominal Strengthening Program.

The core and abdominal strengthening program were integrated into physiotherapy programs in a systematic manner. Individualized exercises were based on the motor ability of each child and included the diaphragmatic breathing, gentle isometric abdominal holds (modified dead-bug or bird-dog positions), and seated trunk forward-lean exercises with controlled bear-down maneuvers that were done only with relaxation of the pelvic-floor. Sessions were performed twice a week in the first month and then advanced to a daily 10- 15 minutes. This gradual training was done to improve intra-abdominal pressure management, posture and coordination of respiratory and pelvic muscles to facilitate bladder emptying and continence. The compliance was good and the adherence was documented every week. This aspect supplemented pelvic physiotherapy in restoring neuromuscular coordination and trunk stability that are important in continence mechanisms.

OTHER

Interferential Current Therapy

IFC sessions were implemented 3 times per week during 8 successive weeks. The duration of every session was 20-30 minutes and used four electrodes; two on the front side of the abdomen above the suprapubic area and two on the back side near the sacral or pelvic-floor area. The frequency used was about 10 kHz to make the interferential waveform more comfortable and acceptable to the patient. The intensity was adjusted to produce a slight tingling feeling without pain and skin integrity was checked on a regular basis. The neuromodulatory effects on detrusor overactivity and sphincter coordination were often combined with pelvic-floor exercises in the same session to enhance the intensity of the neuromodulatory response of IFC.

OTHER

Osteopathy Protocol

The osteopathic intervention in this study aimed to improve the pelvic position, regain the visceral mobility and the neuromuscular activity in children with lumbar or sacral myelomeningocele-related urinary incontinence. Myofascial, visceral, and articular techniques were included in the osteopathic procedures and each targeted a particular dysfunction in the pelvic and lumbosacral areas. In every 30-minute session, treatments were separated into three combined phases: (1) Myofascial release which involved gentle stretching and inhibition of the psoas muscle and deep-tissue mobilization around the obturator foramen to reduce tension and maximize the movement of the pelvic organs (2) Visceral techniques, including soft-tissue mobilization and stretching of the greater omentum and abdominal viscera to enhance visceral mobility and release fascial restraints that affect bladder and bowel mechanics and (3) Articular mobilization, where high-velocity, low-amplitude (HVLA) manipulations we

OTHER

Biofeedback Training Procedure.

Biofeedback training, was used as a fundamental element of therapy to improve voluntary control and co-ordination of the PFMs by children with urinary incontinence due to lumbar or sacral myelomeningocele spina bifida. The intervention was performed through surface electromyographic (EMG) biofeedback (Gymna Uniphy N.V., MYO 200, Bilzen, Belgium) that gave real-time visual and auditory feedback of muscle activity. Two cutaneous EMG electrodes were placed at 3 o'clock and 9 o'clock just in front of the anus, which enabled close attention to the contraction patterns of pubococcygeus, iliococcygeus, coccygeus and puborectalis muscles and synergistic activity of the hip flexors, extensors, abdominals, and thigh muscles. A total of 15 minutes for each session was taken, three times a week and in total, 10 weeks were undertaken with a trained pediatric physiotherapist.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-02-15
Completion
2026-02-20

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07338799 on ClinicalTrials.gov