The Role of Abdominal and Pelvic Floor Retraining in Children With Dysfunctional Voiding
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Number of patients with improved uroflowmetry parameters and curve type
Study Overview
Brief Summary
According to the 2016 International Children's Continence Society standardization of terminology of lower urinary tract function in children, dysfunctional voiding (DV) is a "urodynamic entity characterized by an intermittent and/or fluctuating uroflow rate due to involuntary intermittent contractions of the striated muscle of the external urethral sphincter or pelvic floor during voiding in neurologically normal individuals" . Symptoms vary from mild daytime frequency and urgency to daytime and nighttime wetting, pelvic holding maneuvers, voiding difficulties, urinary tract infections and vesicoureteral reflux (VUR).
There are several ways of treating DV, including urotherapy, pharmacotherapy, surgery in the most severe cases, and even Botulinum toxin type A application in certain children. ''Urotherapy'' stands for non-surgical, non-pharmacologic treatment of lower urinary tract function and can be defined as a bladder re-education or rehabilitation program aiming at correction of filling and voiding difficulties. It involves the change of habits that a child has acquired during the period of toilet training and the development of motor control of the micturition reflex. Urotherapy starts with both parental and child education about the importance of regular hydratation and voiding, constipation treatment and genital hygiene. Together with this standard treatment, the pelvic floor muscle (PFM) retraining is initiated, and it includes pelvic floor exercises and various forms of biofeedback (visual, tactile, auditory, electromyography) with the same aim in mind - to help the child establish pelvic floor awareness and control, and relearn pelvic floor muscle relaxation.
During the past decade, it has been shown that the PFMs are not an isolated unit, but a part of the abdominal capsule, which they form together with the diaphragm, superficial and deep abdominal muscles. As lower abdominal and PFM act synergistically, it is important that both be relaxed during voiding. Diaphragmatic breathing exercises are easy to learn and serve to teach the children abdominal relaxation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 5 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Proven dysfunctional voiding according to the ICCS criteria
- •Signed informed consent by parents motivated to participate in the study
- •Previous treatment by pediatricians in primary care with timed voiding, hydratation and constipation management for three months with no significant success
Exclusion Criteria
- •Neurological disorders
- •Monosymptomatic nocturnal enuresis
- •Mental retardation
- •Structural abnormalities of the lower urinary tract -
Outcomes
Primary Outcomes
Number of patients with improved uroflowmetry parameters and curve type
Time Frame: 12 months
Uroflowmetry with pelvic floor electromyography and post-void residual (PVR) urine measurement will be performed in both groups during monthly visits. It will be carried out twice as a child feels the need to void. PVR urine will be detected by ultrasound less than a minute after voiding.
Proportion of participants with cured or improved urinary incontinence, nocturnal enuresis, urinary tract infections and constipation at the end of the trial in each group of patients
Time Frame: 12 months
During the treatment period, all children in both groups will be asked to keep: a 48hr daytime frequency and volume chart, and a 7-day bladder and defecation diary. Children will be re-evaluated each month after the beginning of the therapy. The analysis of the diaries and charts will start with each visit to the Clinic, noticing changes in urinary incontinence, nocturnal enuresis, defecation frequency and urinary tract infections.
Number of patients with non-, partial and full response in both groups.
Time Frame: 12 months
Based on the clinical manifestations and uroflowmetry parameters, treatment result will be defined as full, partial and non-response. In children in whom urinary incontinence, nocturnal enuresis and urinary tract infections disappear entirely, treatment outcome will be described as "full response"; "partial response" when wetting episodes and urinary tract infections are reduced by more than 50%, and "non-response" when urinary incontinence, nocturnal enuresis and urinary tract infections persist. In children with constipation ≥ 3 bowel movements per week, ≤ 2 episodes of fecal incontinence per month and no abdominal pain with no laxative treatment for \> 1 month will be classified as "full response".
Secondary Outcomes
- Mean pre- and post-treatment Dysfunctional voiding and Incontinence Symptoms Score in children with non-, partial and full response in both groups.(12 months)
- Number of patients with pre-treatment score ≥ 9 in children with non-/ partial and full response in both groups.(12 months)
- Number of patients with post-treatment score < 9 in children with non-/ partial and full response in both groups.(12 months)
Investigators
Vesna Zivkovic
MD, PhD, Professor of physical and rehabilitation medicine
University of Nis