Effectiveness of Multimodal Therapy for Urinary Incontinence in Pediatric Spina Bifida

NCT07338799 | Completed

• 1 other identifier: IRB00014233-56
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Spina Bifida, Open; Myelomeningocele Spina Bifida

Keywords

Urinary Incontinence; Pelvic Floor; Electromyography; Quality of Life; Child

Outcome Measures

Primary Outcomes (1)

• Urinary Continence Improvement

  The main outcome of this study was the improvement of urinary continence which was measured by counting the episodes of incontinence recorded in a three-day urinary bladder diary that used a standardized form. The bladder diary is a validated and proven tool of measuring the frequency of urination, voided volumes, and incontinence occurrences in children's studies (Neveus et al., 2019; Austin et al., 2014). It provides objective and subjective information on bladder habits and therapeutic responsiveness. The parents and their children were advised to closely note the wetting and voiding incidences and any accompanying urgency symptoms during three consecutive days before baseline measurement, at the end of the ten-week intervention and at a twelve-week follow-up. The reduction of incontinence rates at the end of the treatment compared to the baseline was directly evaluated as a measure of the effectiveness of treatment and subsequent increase in the quality of bladder control.

  The baseline, post-intervention (week 10), and follow-up (week 12)

Secondary Outcomes (2)

• Quality of Life (PedsQL)

  at the baseline, immediately after the 10 weeks intervention and at 12 weeks follow up

• Pelvic Floor Muscle Strength (EMG Biofeedback)

  at the baseline, immediately after the 10 weeks intervention and at 12 weeks follow up

Study Arms (2)

Group A

EXPERIMENTAL

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

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

Group B

ACTIVE COMPARATOR

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

Other: Diet and Toileting Education; Other: Pelvic Floor Physiotherapy

Interventions

Diet and Toileting Education OTHER

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

Group A; Group B

Pelvic Floor Physiotherapy OTHER

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

Group A; Group B

Abdominal Strengthening Program. OTHER

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.

Group A

Interferential Current Therapy OTHER

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.

Group A

Osteopathy Protocol OTHER

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

Group A

Biofeedback Training Procedure. OTHER

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.

Group A

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• = 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

faculty of physical therapy, Cairo University

Cairo, Cairo Governorate, P.O.Box 11432, Egypt

Location

Related Links

• Related Info

MeSH Terms

Conditions

Spina Bifida Cystica; Urinary Incontinence

Interventions

Diet; Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

Spinal Dysraphism; Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: January 14, 2026
• Study Start: September 1, 2025
• Primary Completion: February 15, 2026
• Study Completion: February 20, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)