Dysfunctional VoidingNCT06909552
Use of an Educational Video to Improve Adherence to Treatment in Voiding Dysfunction
A study testing Educational Video on Voiding Dysfunction in people with Dysfunctional Voiding, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study aims to see whether an educational video on a common urinary dysfunction leads to improved parent and child perceived adherence to treatments recommendations. 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?
- Educational Video on Voiding Dysfunction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Parents and Caregivers of pediatric urology patients with a diagnosis of Dysfunctional voiding (minimum 100 participants)
- 5-18 years old, no younger than 5 and no older than 18 years old
- Potty-trained - fully independent with toileting, can complete every step of the process and can do so satisfactorily by themselves.
Who cannot join
- Children with Voiding dysfunctionDysfunctional voiders with medically complex conditions (neurogenic bladder, POTS, EDS, etc.)
- Parent's child is notNot a first-time patient (i.e. has been seen in the past for dysfunctional voiding)
- Child has severeSevere intellectual disability, developmental delay, or cognitive impairment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jen Pyrzanowski contact
United States1 site
University of Colorado Anschutz
Aurora, Colorado, 80045
Jennifer Pyrzanowski, 303-724-0769, jennifer.pyrzanowski@cuanschutz.edu
About this study
Official title: Use of an Educational Video to Improve Caregiver Knowledge, Adherence to Recommendations, and Outcomes in Children With Dysfunctional Voiding
This study aims to see whether an educational video on a common urinary dysfunction leads to improved parent and child perceived adherence to treatments recommendations.
Read the detailed description
This study aims to explore whether the use of an educational video on voiding dysfunction, a common urinary dysfunction, leads to improve parents and child perceived adherence to behavioral treatment recommendations. Our main hypothesis explores whether there is improved perceived adherence, and whether this improved perceived adherence leads to better symptom outcomes in this condition.
We do so through randomizing patients to a control and intervention group, where the latter is exposed to the educational video, while the control group experiences standard of care visits/follow-ups. Data is collected through surveys pre and post exposure to the intervention.
- Conditions
- Dysfunctional Voiding
- Being tested
- Educational Video on Voiding Dysfunction
- Keywords
- dysfunctional voiding, educational video, treatment adherence, behavioral modification
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Video on Voiding DysfunctionOther
The educational video is a short 3-minute video which describes the condition in detail, at the level that a parent or child could understand without a medical background.
| Study group | Role | What they receive |
|---|---|---|
| Educational Video | Experimental | Participants will be exposed to a short 3-minute educational video following a visit with their urology provider. Receives: Other: Educational Video on Voiding Dysfunction |
| Control | No intervention | Participants will not be exposed to an educational video; rather, they will receive standard of care education in clinic regarding behavioral treatment modalities at home. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Adherence
Participants will take the TAPQ perceived adherence assessment at time points 4 weeks and 8 weeks.
Measured: 4 weeks, 8 weeks.
Secondary outcomes (2)
Video Acceptability
Immediately after watching the educational video, participants will be asked to complete a questionnaire on the acceptability of the video. this will occur at time frame 0 weeks (for intervention group).
Measured: 0 weeks.
Dysfunctional Voiding Scoring System
Participants will be asked to complete a DVSS survey at timepoints 0 weeks, 4 weeks, and 8 weeks. This DVSS survey will be used to assess symptom improvement throughout the study.
Measured: 0 weeks, 4 weeks, and 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dysfunctional VoidingStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909552
- Sponsor's protocol ID
- 24-1255
- Status last verified
- Jul 2025
- First submitted
- 27 Mar 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: resource limitations
Publications
Feldman AS, Bauer SB. Diagnosis and management of dysfunctional voiding. Curr Opin Pediatr. 2006 Apr;18(2):139-47. doi: 10.1097/01.mop.0000193289.64151.49.
PubMed 16601493Dyson PA, Beatty S, Matthews DR. An assessment of lifestyle video education for people newly diagnosed with type 2 diabetes. J Hum Nutr Diet. 2010 Aug;23(4):353-9. doi: 10.1111/j.1365-277X.2010.01077.x. Epub 2010 May 20.
PubMed 20497292
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of an Educational Video to Improve Caregiver Knowledge, Adherence to Recommendations, and Outcomes in Children With Dysfunctional Voiding
- ClinicalTrials.gov ID
- NCT06909552
- Acronym / sponsor ID
- 24-1255
- Conditions
- Dysfunctional Voiding
- Keywords
- dysfunctional voiding, educational video, treatment adherence, behavioral modification
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 3 Apr 2025 (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.
This study aims to see whether an educational video on a common urinary dysfunction leads to improved parent and child perceived adherence to treatments recommendations.
Detailed description
This study aims to explore whether the use of an educational video on voiding dysfunction, a common urinary dysfunction, leads to improve parents and child perceived adherence to behavioral treatment recommendations. Our main hypothesis explores whether there is improved perceived adherence, and whether this improved perceived adherence leads to better symptom outcomes in this condition.
We do so through randomizing patients to a control and intervention group, where the latter is exposed to the educational video, while the control group experiences standard of care visits/follow-ups. Data is collected through surveys pre and post exposure to the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Video | Experimental | Other: Educational Video on Voiding DysfunctionParticipants will be exposed to a short 3-minute educational video following a visit with their urology provider. |
| Control | No intervention | –Participants will not be exposed to an educational video; rather, they will receive standard of care education in clinic regarding behavioral treatment modalities at home. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Parents and Caregivers of pediatric urology patients with a diagnosis of Dysfunctional voiding (minimum 100 participants)
- 5-18 years old, no younger than 5 and no older than 18 years old
- Potty-trained - fully independent with toileting, can complete every step of the process and can do so satisfactorily by themselves.
Key exclusion criteria (3 listed)
- Children with Voiding dysfunctionDysfunctional voiders with medically complex conditions (neurogenic bladder, POTS, EDS, etc.)
- Parent's child is notNot a first-time patient (i.e. has been seen in the past for dysfunctional voiding)
- Child has severeSevere intellectual disability, developmental delay, or cognitive impairment.
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 |
|---|---|---|
| Educational Video on Voiding DysfunctionThe educational video is a short 3-minute video which describes the condition in detail, at the level that a parent or child could understand without a medical background. | Other | Educational Video |
Primary outcome
Perceived Adherence
Time frame: 4 weeks, 8 weeks.
Participants will take the TAPQ perceived adherence assessment at time points 4 weeks and 8 weeks.
2 secondary outcomes
Video Acceptability
Time frame: 0 weeks.
Dysfunctional Voiding Scoring System
Time frame: 0 weeks, 4 weeks, and 8 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Background: PubMed 16601493Feldman AS, Bauer SB. Diagnosis and management of dysfunctional voiding. Curr Opin Pediatr. 2006 Apr;18(2):139-47. doi: 10.1097/01.mop.0000193289.64151.49.
- Background: PubMed 20497292Dyson PA, Beatty S, Matthews DR. An assessment of lifestyle video education for people newly diagnosed with type 2 diabetes. J Hum Nutr Diet. 2010 Aug;23(4):353-9. doi: 10.1111/j.1365-277X.2010.01077.x. Epub 2010 May 20.
- Individual participant dataSharing planned: No. resource limitations
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 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.
Jen Pyrzanowski contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Video on Voiding Dysfunction in people with Dysfunctional Voiding, run by University of Colorado, Denver at 1 site in United States.
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 3 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: opening soon, as of the sponsor's last update on 25 Jul 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marguerite Korber, CPNP (720-777-6523, marguerite.korber@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Adherence (time frame: 4 weeks, 8 weeks.). 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 NCT06909552, which also lists 2 linked publications.
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 25 Jul 2025.