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

Dysfunctional Voiding Clinical Trial

Official title:

The Role of Abdominal and Pelvic Floor Retraining in Children With Dysfunctional Voiding

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04981340
• Other study ID #: 43011
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 18, 2021
• Est. completion date: October 30, 2022

Study information

• Verified date: July 2021
• Source: University of Nis
• Contact: Vesna D Zivkovic, MD
• Phone: +381648839124
• Email: petvesna67[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 30, 2022
• Est. primary completion date: September 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Dysfunctional Voiding

Intervention

Behavioral:
• Diaphragmatic breathing
Same as previously described
• Standard urotherapy
Same as previously described

Locations

Country	Name	City	State
Serbia	Medical Faculty	Nis

Sponsors (1)

Lead Sponsor	Collaborator
University of Nis

Country where clinical trial is conducted

Serbia, 

References & 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, Nevéus 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Mean pre- and post-treatment Dysfunctional voiding and Incontinence Symptoms Score in children with non-, partial and full response in both groups.	The Dysfunctional Voiding and Incontinence Scoring System will be completed at the beginning and the end of the 12-month treatment period. This questionnaire consists of 13 questions relating to daytime and nighttime wetting, degree of wetting, frequency of urination, voiding symptoms ( straining, intermittency), pain, urgency, urge incontinence, pelvic holding maneuvers, defecation frequency, and one question concerning the impact of voiding disorder on quality of life. Parents are expected to score the frequency and intensity of wetting during the day and night in the first four questions in the presence of their child, and the last eight questions are answered in a yes or no manner. Each answer, except the last question, is scored to produce a total score of between 0 and 35. The presence of voiding dysfunction (excluding quality of life score) in both genders is indicated by a total score of 9 or more.	12 months
Secondary	Number of patients with pre-treatment score = 9 in children with non-/ partial and full response in both groups.	In order to determine sensitivity and specificity of the initial and final score in predicting treatment outcome, all children will be divided in two groups. One group will consist of all children with full response, while the second group will consist of children with partial and non-response. Individual pre- and post-treatment total scores will be compared to the treatment outcome.	12 months
Secondary	Number of patients with post-treatment score < 9 in children with non-/ partial and full response in both groups.		12 months