NCT07268963

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2025

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

December 8, 2025

Status Verified

November 1, 2025

Enrollment Period

3.3 years

First QC Date

November 25, 2025

Last Update Submit

November 25, 2025

Conditions

Keywords

GiggleDysfunctional voidingIncontinenceBiofeedback

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Biofeedback-Related Resolution

    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 Outcomes (1)

  • Predictive Factors of Treatment Response

    18 weeks

Study Arms (2)

Giggle incontinence

Patients who received biofeedback therapy for giggle incontinence

Behavioral: Biofeedback therapy

Dysfunctional voiding

Patients who received biofeedback therapy for dysfunctional voiding

Behavioral: Biofeedback therapy

Interventions

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 voidingGiggle incontinence

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • Patients diagnosed with dysfunctional voiding or giggle incontinence
  • Patients treated with biofeedback therapy

You may not qualify if:

  • Presence of anatomical or neurological problems
  • Patients with missing data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sancaktepe Sehit Prof dr Ilhan Varank Training and Research Hospital

Istanbul, Kadikoy, 34000, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 40221717BACKGROUND
  • 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.

    PMID: 38307925BACKGROUND

MeSH Terms

Interventions

Biofeedback, Psychology

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

November 25, 2025

First Posted

December 8, 2025

Study Start

September 1, 2022

Primary Completion

December 1, 2025

Study Completion

April 1, 2026

Last Updated

December 8, 2025

Record last verified: 2025-11

Locations