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

NCT ID: NCT04981340

Last Updated: 2021-07-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-18
• Study Completion Date: 2022-10-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard urotherapy + Diaphragmatic breathing exercises+ pelvic floor exercises

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.

Group Type: EXPERIMENTAL

Diaphragmatic breathing

Intervention Type: BEHAVIORAL

Same as previously described

Standard urotherapy

Intervention Type: BEHAVIORAL

Same as previously described

Standard urotherapy

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.

Group Type: ACTIVE_COMPARATOR

Standard urotherapy

Intervention Type: BEHAVIORAL

Same as previously described

Interventions

Diaphragmatic breathing

Same as previously described

Intervention Type: BEHAVIORAL

Standard urotherapy

Same as previously described

Intervention Type: BEHAVIORAL

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 -

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nis

OTHER

Sponsor Role: lead

Responsible Party

Vesna Zivkovic

MD, PhD, Professor of physical and rehabilitation medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ivona Stankovic, MD

Role: STUDY_DIRECTOR

University of Nis Medical faculty

Locations

Medical Faculty

Niš, , Serbia

Countries

Serbia

Central Contacts

Vesna D Zivkovic, MD

Role: CONTACT

petvesna67@gmail.com

+381648839124

References

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.

Reference Type: BACKGROUND

PMID: 25772695 (View on PubMed)

Other Identifiers

43011

Identifier Type: -

Identifier Source: org_study_id