Standard Urotherapy With or Without Biofeedback-Based Pelvic Floor Muscle Training for Dysfunctional Voiding in Children

NCT07149532 | Recruiting

• 1 other identifier: 36264PR1112/2/25
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Biofeedback; Medical Treatment; Dysfunctional Voiding; Children

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  Overall response rate will be recorded.

  6 months post-procedure

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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

Other: Biofeedback-based pelvic floor muscle training

Group 2

EXPERIMENTAL

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

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

Interventions

Biofeedback-based pelvic floor muscle training OTHER

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

Group 1

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

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

Group 2

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

Central Study Contacts

Mohamed I Elmaadawy, MD

CONTACT

00201060245430; Mohamed.elmaadawy@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 2, 2025
• Study Start: February 26, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)