Dysfunctional VoidingPhase 4NCT07743515
Standard Urotherapy With or Without Biofeedback Based Pelvic Floor Muscle Training for Dysfunctional Voiding in Children
A Phase 4 study testing Standard Urotherapy and Standard Urotherapy with Biofeedback-Based Pelvic Floor Muscle Training in people with Dysfunctional Voiding, run by Tanta University at 1 site in Egypt.
Trial summary
Standard Urotherapy with or without Biofeedback-Based Pelvic Floor Muscle Training for Dysfunctional Voiding in Children Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Dysfunctional Voiding
- What is being tested?
- Standard Urotherapy and Standard Urotherapy with Biofeedback-Based Pelvic Floor Muscle Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 1 Mar 2026
- Phase
- Phase 4
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Dysfunctional voiding
Who cannot join
- Lower urinary tract trauma (n=1),
- Urinary tract anomalies
- Neurological disorders
- Cognitive impairment
- Previous treatment for dysfunctional voiding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Standard Urotherapy With or Without Biofeedback-Based Pelvic Floor Muscle Training for Dysfunctional Voiding in Children A Randomized Clinical Study
Standard Urotherapy with or without Biofeedback-Based Pelvic Floor Muscle Training for Dysfunctional Voiding in Children
Read the detailed description
Standard Urotherapy with or without Biofeedback-Based Pelvic Floor Muscle Training for Dysfunctional Voiding in Children A Randomized Clinical Study
- Conditions
- Dysfunctional Voiding
- Being tested
- Standard Urotherapy, Standard Urotherapy with Biofeedback-Based Pelvic Floor Muscle Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard UrotherapyOther
Standard Urotherapy
Standard Urotherapy with Biofeedback-Based Pelvic Floor Muscle TrainingOther
Standard Urotherapy with Biofeedback-Based Pelvic Floor Muscle Training
| Study group | Role | What they receive |
|---|---|---|
| Standard Urotherapy | Active comparator | Not described Receives: Other: Standard Urotherapy |
| Standard Urotherapy with Biofeedback-Based Pelvic Floor Muscle Training | Experimental | Not described Receives: Other: Standard Urotherapy with Biofeedback-Based Pelvic Floor Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of complete response
Achievement of complete response according to the standard guideline ecommendations
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Mar 2025
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ibrahim Ahmed Elmaadawy, Tanta University
- Investigators
- Mohamed elmaadawy, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743515
- Sponsor's protocol ID
- P3072026
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Urotherapy With or Without Biofeedback-Based Pelvic Floor Muscle Training for Dysfunctional Voiding in Children A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07743515
- Acronym / sponsor ID
- P3072026
- Conditions
- Dysfunctional Voiding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 4 Aug 2026 (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.
Standard Urotherapy with or without Biofeedback-Based Pelvic Floor Muscle Training for Dysfunctional Voiding in Children
Detailed description
Standard Urotherapy with or without Biofeedback-Based Pelvic Floor Muscle Training for Dysfunctional Voiding in Children A Randomized Clinical Study
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 | Active comparator | Other: Standard Urotherapy |
| Standard Urotherapy with Biofeedback-Based Pelvic Floor Muscle Training | Experimental | Other: Standard Urotherapy with Biofeedback-Based Pelvic Floor Muscle Training |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Dysfunctional voiding
Key exclusion criteria (5 listed)
- Lower urinary tract trauma (n=1),
- Urinary tract anomalies
- Neurological disorders
- Cognitive impairment
- Previous treatment for dysfunctional voiding
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 |
|---|---|---|
| Standard UrotherapyStandard Urotherapy | Other | Standard Urotherapy |
| Standard Urotherapy with Biofeedback-Based Pelvic Floor Muscle TrainingStandard Urotherapy with Biofeedback-Based Pelvic Floor Muscle Training | Other | Standard Urotherapy with Biofeedback-Based Pelvic Floor Muscle Training |
Primary outcome
Achievement of complete response
Time frame: 6 months
Achievement of complete response according to the standard guideline ecommendations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
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.
Mohamed elmaadawy principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standard Urotherapy and Standard Urotherapy with Biofeedback-Based Pelvic Floor Muscle Training in people with Dysfunctional Voiding, run by Tanta University at 1 site in Egypt.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 4 Aug 2026. 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of complete response (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2026.