- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07268963
Biofeedback for Dysfunctional Voiding and Giggle Incontinence
November 25, 2025 updated by: Furkan Adem Canbaz, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
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.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kadikoy
-
Istanbul, Kadikoy, Turkey (Türkiye), 34000
- Sancaktepe Sehit Prof Dr Ilhan Varank Training and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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
Description
Inclusion Criteria:
- Patients diagnosed with dysfunctional voiding or giggle incontinence
- Patients treated with biofeedback therapy
Exclusion Criteria:
- Presence of anatomical or neurological problems
- Patients with missing data
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Giggle incontinence
Patients who received biofeedback therapy for giggle incontinence
|
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.
|
|
Dysfunctional voiding
Patients who received biofeedback therapy for dysfunctional voiding
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
From enrollment to the end of treatment at 18 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Predictive Factors of Treatment Response
Time Frame: 18 weeks
|
Age, gender, and diagnosis will be evaluated as potential predictive factors of treatment response
|
18 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Gonzalez-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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2022
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
April 1, 2026
Study Registration Dates
First Submitted
November 25, 2025
First Submitted That Met QC Criteria
November 25, 2025
First Posted (Actual)
December 8, 2025
Study Record Updates
Last Update Posted (Actual)
December 8, 2025
Last Update Submitted That Met QC Criteria
November 25, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BF DV + Giggle
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
I do not have any idea.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dysfunctional Voiding
-
University of Colorado, DenverNot yet recruitingDysfunctional VoidingUnited States
-
Halic UniversityCompleted
-
Buddhist Tzu Chi General HospitalCompleted
-
Tanta UniversityRecruitingChildren | Biofeedback | Dysfunctional Voiding | Medical TreatmentEgypt
-
Izmir University of EconomicsHealth Institutes of TurkeyActive, not recruitingChildren | Ultrasound | Pelvic Floor Muscle Training | Dysfunctional Voiding | DNSTurkey (Türkiye)
-
Tanta UniversityRecruitingChildren | Dysfunctional Voiding | Local Injection | Botulinium Toxin-A | Refractory Nocturnal EneuresisEgypt
-
University of NisNot yet recruitingDiaphragmatic Breathing Exercises and Pelvic Floor Retraining in Children With Dysfunctional VoidingDysfunctional VoidingSerbia
-
Seoul National University HospitalActive, not recruitingBowel Dysfunction | Bladder Dysfunction | Pediatric Urology | Dysfunctional VoidingKorea, Republic of
-
University of Massachusetts, WorcesterCompletedPostoperative Pain | Dysfunctional VoidingUnited States
-
Duke UniversityCompletedUrinary Dysfunction | Dysfunctional VoidingUnited States
Clinical Trials on Biofeedback therapy
-
Augusta UniversityCompleted
-
Augusta UniversityNational Institutes of Health (NIH)CompletedConstipation | Dyssynergia
-
National Taiwan University HospitalNational Taiwan University Hospital, Yun-Lin BranchCompletedPanic Disorder | Feedback, PsychologicalTaiwan
-
University of California, San DiegoUnknown
-
University of AlcalaCompleted
-
University of NottinghamNational Institute for Health Research, United KingdomCompletedStroke, Acute | Dysphagia, OropharyngealUnited Kingdom
-
Cairo UniversityRecruiting
-
Augusta UniversityRecruitingUrinary Incontinence | Fecal Incontinence | Dyssynergic DefecationUnited States
-
Taibah UniversityCompletedBladder Dysfunction on Patients With Multiple SclerosisSaudi Arabia
-
National Institute for Locomotor Disabilities (Divyangjan)...Completed