Effectiveness of Multimodal Therapy for Urinary Incontinence in Pediatric Spina Bifida (NCT07338799) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness of Multimodal Therapy for Urinary Incontinence in Pediatric Spina Bifida
Egypt66 participantsStarted 2025-09-01
Plain-language 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.
Who can participate
Age range
10 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Urinary Continence Improvement
Timeframe: The baseline, post-intervention (week 10), and follow-up (week 12)