Diaphragmatic Breathing Exercises and Pelvic Floor Retraining in Children With Dysfunctional Voiding

NCT04981340 | Unknown

• 1 other identifier: 43011
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysfunctional Voiding

Keywords

dysfunctional voiding; diaphragmatic breathing; urotherapy; pelvic floor exercises; The Dysfunctional Voiding and Incontinence Scoring System

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  12 months

• Number of patients with improved uroflowmetry parameters and curve type

  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.

  12 months

• Number of patients with non-, partial and full response in both groups.

  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".

  12 months

Secondary Outcomes (3)

• 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

Study Arms (2)

Standard urotherapy + Diaphragmatic breathing exercises+ pelvic floor exercises

EXPERIMENTAL

Diaphragmatic breathing exercises will be demonstrated by a qualified physiotherapist. Exercises will be done in lying and sitting positions respectively. In supine, with the lower extremities supported over a pillow and hands positioned on the abdominal muscles, children will be asked to inhale the air through the nose, bulge the abdomen outwards as much as possible, hold their breath for a few seconds, and then exhale slowly through pursed lips. The same exercise will be then performed in both side-lying positions and in a sitting position in front of the mirror. Children will be instructed to watch the anterior abdominal wall movement during inspiration and to repeat the same action while seated on the toilet to initiate voiding. They will be asked to perform the diaphragmatic breathing exercises daily at home.

Behavioral: Diaphragmatic breathing; Behavioral: Standard urotherapy

Standard urotherapy

ACTIVE COMPARATOR

Standard urotherapy will start with the education of the children and their parents about the normal function of the bladder and external urinary sphincter and the nature of their voiding disorder. The importance of regular fluid intake (200 ml 5-6 times per day) and regular voiding will be explained. Special voiding and defecation diaries that a child has to fill out at home will be provided. An optimal voiding posture will be demonstrated in front of a mirror: a sitting position, with feet supported, hips abducted and abdominal muscles relaxed.

Behavioral: Standard urotherapy

Interventions

Diaphragmatic breathing BEHAVIORAL

Same as previously described

Standard urotherapy + Diaphragmatic breathing exercises+ pelvic floor exercises

Standard urotherapy BEHAVIORAL

Same as previously described

Standard urotherapy; Standard urotherapy + Diaphragmatic breathing exercises+ pelvic floor exercises

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Neurological disorders
• Monosymptomatic nocturnal enuresis
• Mental retardation
• Structural abnormalities of the lower urinary tract -

Sponsors & Collaborators

• University of Nis: lead

Study Sites (1)

Medical Faculty

Niš, 18000, Serbia

Location

Related Publications (1)

• 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.

  PMID: 25772695 BACKGROUND

Study Officials

• Ivona Stankovic, MD

  University of Nis Medical faculty

  STUDY DIRECTOR

Central Study Contacts

Vesna D Zivkovic, MD

CONTACT

+381648839124; petvesna67@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor of physical and rehabilitation medicine

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 29, 2021
• Study Start: September 18, 2021
• Primary Completion: September 29, 2022
• Study Completion: October 30, 2022
• Last Updated: July 29, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)