Biofeedback Therapy Alone Versus Biofeedback Therapy With Medical Treatment for Dysfunctional Voiding in Children

NCT ID: NCT07149532

Last Updated: 2025-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-26

Study Completion Date

2026-01-01

Brief Summary

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This study aims to compare the efficiency of biofeedback therapy alone versus biofeedback therapy with medical treatment for dysfunctional voiding in children.

Detailed Description

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Dysfunctional voiding (DV) in children may result in lower urinary tract symptoms (LUTS), such as urgency, frequency, urinary incontinence, and difficulty in urination.

Noninvasive assessments and biofeedback-based pelvic floor muscle training (PFMT) can effectively improve LUTS and protect upper urinary tract function in children, in addition to medical treatment.

Conditions

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Biofeedback Medical Treatment Dysfunctional Voiding Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

Patients will receive the biofeedback-based pelvic floor muscle training (PFMT) alone.

Group Type ACTIVE_COMPARATOR

Biofeedback-based pelvic floor muscle training

Intervention Type OTHER

Patients will receive the biofeedback-based pelvic floor muscle training (PFMT) alone.

Group 2

Patients will receive the biofeedback-based pelvic floor muscle training (PFMT) with medical treatment.

Group Type EXPERIMENTAL

Biofeedback-based pelvic floor muscle training (PFMT) with medical treatment

Intervention Type OTHER

Patients will receive the biofeedback-based pelvic floor muscle training (PFMT) with medical treatment.

Interventions

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Biofeedback-based pelvic floor muscle training

Patients will receive the biofeedback-based pelvic floor muscle training (PFMT) alone.

Intervention Type OTHER

Biofeedback-based pelvic floor muscle training (PFMT) with medical treatment

Patients will receive the biofeedback-based pelvic floor muscle training (PFMT) with medical treatment.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children less than 18 years old.
* Both sexes.
* Children with dysfunctional voiding.

Exclusion Criteria

* Patients with cognitive function impairment.
* Patients who received any care for dysfunctional voiding.
* Children with known anatomical anomalies of the urinary tract.
* Children with known neurological anomalies (spinal dysraphism, multiple sclerosis, lumbar or spinal neuritis……… etc).
* Children with a history of back or lower urinary tract trauma.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Ibrahim Ahmed Elmaadawy

Lecturer of Urology, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University

Tanta, El-Gharbia, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed I Elmaadawy, MD

Role: CONTACT

00201060245430

Facility Contacts

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Mohamed I Elmaadawy, MD

Role: primary

00201060245430

Other Identifiers

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36264PR1112/2/25

Identifier Type: -

Identifier Source: org_study_id

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