Biofeedback TherapyNCT07268963
Biofeedback for Dysfunctional Voiding and Giggle Incontinence
An observational study of Biofeedback Therapy and Dysfunctional Voiding, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the efficacy of biofeedback treatment for dysfunctional voiding and giggle incontinence in children. Predictive factors of treatment success will also researched. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Biofeedback Therapy, Dysfunctional Voiding, Giggle Incontinence
- What is being tested?
- Biofeedback therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to Apr 2026
- Phase
- Observational
- 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients who were received biofeedback therapy for dysfunctional voiding and giggle incontinece in pediatric urology clinic of Sancaktepe Sehit Prof Dr Ilhan Varank Training and Research Hospital
Who may be able to join
- Patients diagnosed with dysfunctional voiding or giggle incontinence
- Patients treated with biofeedback therapy
Who cannot join
- Presence of anatomical or neurological problems
- Patients with missing data
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sancaktepe Sehit Prof dr Ilhan Varank Training and Research Hospital
Istanbul, Kadikoy, 34000
About this study
Official title: Biofeedback for Dysfunctional Voiding and Giggle Incontinence in Children
This study aims to evaluate the efficacy of biofeedback treatment for dysfunctional voiding and giggle incontinence in children. Predictive factors of treatment success will also researched.
Read the detailed description
A total of approximately 60 patients who received biofeedback therapy will be evaluated retrospectively. Treatment success rates among these patients will be evaluated. Patients will be divided into mainly two groups according to the diagnosis.
- Being tested
- Biofeedback therapy
- Keywords
- Giggle, Dysfunctional voiding, Incontinence, Biofeedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback therapyBehavioural
Biofeedback therapy is a behavioral treatment method that helps patients become more aware of and gain better control over their pelvic floor muscles. Using EMG electrodes, muscle activity is monitored and presented to the patient visually or audibly, enabling them to recognize and correct improper muscle contractions or relaxations that contribute to urinary incontinence.
| Study group | Role | What they receive |
|---|---|---|
| Giggle incontinence | Patients who received biofeedback therapy for giggle incontinence Receives: Behavioral: Biofeedback therapy | |
| Dysfunctional voiding | Patients who received biofeedback therapy for dysfunctional voiding Receives: Behavioral: Biofeedback therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Biofeedback-Related Resolution
Participants achieved a complete response which means 100% improvement in resolution of incontinence and abnormal voiding pattern
Measured: From enrollment to the end of treatment at 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Sep 2022
- Primary completionDec 2025 (estimated)
- Study completionApr 2026 (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 Biofeedback TherapyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Furkan Adem Canbaz, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268963
- Sponsor's protocol ID
- BF DV + Giggle
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I do not have any idea.
Publications
Sadeghi M, Oskouie IM, Naserghandi A, Arvin A, Majidi Zolbin M. Exploring dysfunctional voiding in girls: a comprehensive literature review of assessment and management strategies. BMC Urol. 2025 Apr 12;25(1):87. doi: 10.1186/s12894-025-01772-0.
PubMed 40221717Gonzalez-Maldonado AA, Garcia-Merida M. Giggle incontinence: a scoping review. Pediatr Res. 2024 Jun;95(7):1720-1725. doi: 10.1038/s41390-024-03065-y. Epub 2024 Feb 2.
PubMed 38307925
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biofeedback for Dysfunctional Voiding and Giggle Incontinence in Children
- ClinicalTrials.gov ID
- NCT07268963
- Acronym / sponsor ID
- BF DV + Giggle
- Keywords
- Giggle, Dysfunctional voiding, Incontinence, Biofeedback
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 8 Dec 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 evaluate the efficacy of biofeedback treatment for dysfunctional voiding and giggle incontinence in children. Predictive factors of treatment success will also researched.
Detailed description
A total of approximately 60 patients who received biofeedback therapy will be evaluated retrospectively. Treatment success rates among these patients will be evaluated. Patients will be divided into mainly two groups according to the diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Giggle incontinence | – | Behavioral: Biofeedback therapyPatients who received biofeedback therapy for giggle incontinence |
| Dysfunctional voiding | – | Behavioral: Biofeedback therapyPatients who received biofeedback therapy for dysfunctional voiding |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients who were received biofeedback therapy for dysfunctional voiding and giggle incontinece in pediatric urology clinic of Sancaktepe Sehit Prof Dr Ilhan Varank Training and Research Hospital
Key inclusion criteria (2 listed)
- Patients diagnosed with dysfunctional voiding or giggle incontinence
- Patients treated with biofeedback therapy
Key exclusion criteria (2 listed)
- Presence of anatomical or neurological problems
- Patients with missing data
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 |
|---|---|---|
| Biofeedback therapyBiofeedback therapy is a behavioral treatment method that helps patients become more aware of and gain better control over their pelvic floor muscles. Using EMG electrodes, muscle activity is monitored and presented to the patient visually or audibly, enabling them to recognize and correct improper muscle contractions or relaxations that contribute to urinary incontinence. | Behavioural | Dysfunctional voiding, Giggle incontinence |
Primary outcome
Number of Participants with Biofeedback-Related Resolution
Time frame: From enrollment to the end of treatment at 18 weeks
Participants achieved a complete response which means 100% improvement in resolution of incontinence and abnormal voiding pattern
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 8 Dec 2025.
- Background: PubMed 40221717Sadeghi M, Oskouie IM, Naserghandi A, Arvin A, Majidi Zolbin M. Exploring dysfunctional voiding in girls: a comprehensive literature review of assessment and management strategies. BMC Urol. 2025 Apr 12;25(1):87. doi: 10.1186/s12894-025-01772-0.
- Background: PubMed 38307925Gonzalez-Maldonado AA, Garcia-Merida M. Giggle incontinence: a scoping review. Pediatr Res. 2024 Jun;95(7):1720-1725. doi: 10.1038/s41390-024-03065-y. Epub 2024 Feb 2.
- Individual participant dataSharing planned: Undecided. I do not have any idea.
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Comparing the Effect of Two Types of Pelvic Floor Muscle Stimulation Devices to Improve Symptoms of Urinary Incontinence in Women.
Urinary Incontinence, Mixed Urinary Incontinence
Not yet recruiting
Effects of Motor Control Exercises With and Without Pressure Biofeedback in Recurrent Low Back Pain (MCE)
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biofeedback Therapy and Dysfunctional Voiding, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 8 Dec 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 Turkey (Türkiye). 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?
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?
Number of Participants with Biofeedback-Related Resolution (time frame: From enrollment to the end of treatment at 18 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 NCT07268963, 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 8 Dec 2025.