Effectiveness of Multimodal Therapy for Urinary Incontinence in Pediatric Spina Bifida

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 10 to 18 years
• All sexes
• No healthy volunteers
• Child, Adult

Trial locations and contacts

1 site in 1 country.

About this study

Official title: 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

Conditions

Myelomeningocele Spina Bifida, Spina Bifida, Open

Being tested

Diet and Toileting Education, Pelvic Floor Physiotherapy, Abdominal Strengthening Program., Interferential Current Therapy, Osteopathy Protocol

Keywords

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

Medical subject headings

Spina Bifida Cystica, Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Diet and Toileting EducationOther

  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

• Pelvic Floor PhysiotherapyOther

  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

• 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.

• Interferential Current TherapyOther

  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.

• Osteopathy ProtocolOther

  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

• 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted14 Jan 2026
2. Study start1 Sep 2025
3. Primary completion15 Feb 2026
4. Study completion20 Feb 2026

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Myelomeningocele Spina BifidaStudies of the same condition, open and under way.
• More trials run by Cairo UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.