Clinical trial NCT04981340: Diaphragmatic Breathing Exercises and Pelvic Floor Retraining in Children With Dysfunctional Voiding
Official title: The Role of Abdominal and Pelvic Floor Retraining in Children With Dysfunctional Voiding
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dysfunctional Voiding
Keywords: dysfunctional voiding
diaphragmatic breathing
urotherapy
pelvic floor exercises
The Dysfunctional Voiding and Incontinence Scoring System
Lead sponsor: University of Nis
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Proven dysfunctional voiding according to the ICCS criteria
2. Signed informed consent by parents motivated to participate in the study
3. Previous treatment by pediatricians in primary care with timed voiding, hydratation and constipation management for three months with no significant success

Exclusion Criteria:

1. Neurological disorders
2. Monosymptomatic nocturnal enuresis
3. Mental retardation
4. Structural abnormalities of the lower urinary tract -

Primary outcomes:
measure: 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
timeFrame: 12 months
measure: Number of patients with improved uroflowmetry parameters and curve type
timeFrame: 12 months
measure: Number of patients with non-, partial and full response in both groups.
timeFrame: 12 months
Secondary outcomes:
measure: Mean pre- and post-treatment Dysfunctional voiding and Incontinence Symptoms Score in children with non-, partial and full response in both groups.
timeFrame: 12 months
measure: Number of patients with pre-treatment score ≥ 9 in children with non-/ partial and full response in both groups.
timeFrame: 12 months
measure: Number of patients with post-treatment score < 9 in children with non-/ partial and full response in both groups.
timeFrame: 12 months
Other outcomes:
Locations:
city: Nis
country: Serbia
facility: Medical Faculty
Study officials:
affiliation: University of Nis Medical faculty
name: Ivona Stankovic, MD
role: STUDY_DIRECTOR
References:
citation: Austin PF, Bauer SB, Bower W, Chase J, Franco I, Hoebeke P, Rittig S, Walle JV, von Gontard A, Wright A, Yang SS, Neveus T. The standardization of terminology of lower urinary tract function in children and adolescents: Update report from the standardization committee of the International Children's Continence Society. Neurourol Urodyn. 2016 Apr;35(4):471-81. doi: 10.1002/nau.22751. Epub 2015 Mar 14.