Dysfunctional VoidingNCT04981340
Diaphragmatic Breathing Exercises and Pelvic Floor Retraining in Children With Dysfunctional Voiding
A study testing Diaphragmatic breathing and Standard urotherapy in people with Dysfunctional Voiding, run by University of Nis at 1 site in Serbia.
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… Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Dysfunctional Voiding
- What is being tested?
- Diaphragmatic breathing and Standard urotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSerbia
- Study dates
- 18 Sep 2021to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Neurological disorders
- Monosymptomatic nocturnal enuresis
- Mental retardation
- Structural abnormalities of the lower urinary tract -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Abdominal and Pelvic Floor Retraining in Children With Dysfunctional Voiding
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
- Being tested
- Diaphragmatic breathing, Standard urotherapy
- Keywords
- dysfunctional voiding, diaphragmatic breathing, urotherapy, pelvic floor exercises, The Dysfunctional Voiding and Incontinence Scoring System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic breathingBehavioural
Same as previously described
Standard urotherapyBehavioural
Same as previously described
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard urotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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".
Measured: 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.
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.
Measured: 12 months
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.
Measured: 12 months
Number of patients with post-treatment score < 9 in children with non-/ partial and full response in both groups.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start18 Sep 2021 (estimated)
- Primary completion29 Sep 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dysfunctional VoidingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vesna Zivkovic, University of Nis
- Investigators
- Ivona Stankovic, MD, Study director, University of Nis Medical faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981340
- Sponsor's protocol ID
- 43011
- Status last verified
- Jul 2021
- First submitted
- 12 Jul 2021
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25772695
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Abdominal and Pelvic Floor Retraining in Children With Dysfunctional Voiding
- ClinicalTrials.gov ID
- NCT04981340
- Acronym / sponsor ID
- 43011
- Conditions
- Dysfunctional Voiding
- Keywords
- dysfunctional voiding, diaphragmatic breathing, urotherapy, pelvic floor exercises, The Dysfunctional Voiding and Incontinence Scoring System
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of NisUniversity, hospital or other
- Study start
- 18 Sep 2021 (estimated)
- Primary completion
- 29 Sep 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 29 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard urotherapy + Diaphragmatic breathing exercises+ pelvic floor exercises | Experimental | Behavioral: Diaphragmatic breathing, Behavioral: Standard urotherapyDiaphragmatic 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. |
| Standard urotherapy | Active comparator | Behavioral: Standard urotherapyStandard 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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Neurological disorders
- Monosymptomatic nocturnal enuresis
- Mental retardation
- Structural abnormalities of the lower urinary tract -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragmatic breathingSame as previously described | Behavioural | Standard urotherapy + Diaphragmatic breathing exercises+ pelvic floor exercises |
| Standard urotherapySame as previously described | Behavioural | Standard urotherapy, Standard urotherapy + Diaphragmatic breathing exercises+ pelvic floor exercises |
Primary outcome
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 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.
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".
3 secondary outcomes
Mean pre- and post-treatment Dysfunctional voiding and Incontinence Symptoms Score in children with non-, partial and full response in both groups.
Time frame: 12 months
Number of patients with pre-treatment score ≥ 9 in children with non-/ partial and full response in both groups.
Time frame: 12 months
Number of patients with post-treatment score < 9 in children with non-/ partial and full response in both groups.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Background: PubMed 25772695Austin 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.
- Individual participant dataSharing planned: No
Related trials for Dysfunctional Voiding
Recruiting
Local Injection of Botulinium Toxin-A in Children With Dysfunctional Voiding or Refractory Nocturnal Eneuresis
Local Injection, Botulinium Toxin-A
Active, not recruitingObservational study
Biofeedback for Dysfunctional Voiding and Giggle Incontinence
Biofeedback Therapy, Dysfunctional Voiding
Not yet recruiting
Use of an Educational Video to Improve Adherence to Treatment in Voiding Dysfunction
Dysfunctional Voiding
Not yet recruitingObservational study
Case Control Study to Investigate the Use of Urethral Pressure Profile Measurement in Children
Dysfunctional Voiding, Stress Incontinence, Urinary
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivona Stankovic, MD study director
University of Nis Medical faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic breathing and Standard urotherapy in people with Dysfunctional Voiding, run by University of Nis at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vesna D Zivkovic, MD (+381648839124, petvesna67@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04981340, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.