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NCT Number: NCT07149532

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

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

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Key information

Conditions

Biofeedback Children Dysfunctional Voiding Medical Treatment

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location status: Recruiting

Location contact

Mohamed I Elmaadawy, MD

CONTACT

[email protected]

00201060245430

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biofeedback-based pelvic floor muscle training

Other

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

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.

Primary outcomes

  1. Overall response rate

    Time frame: 6 months post-procedure

    Overall response rate will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed I Elmaadawy, MD

CONTACT

[email protected]

00201060245430

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Standard Urotherapy With or Without Biofeedback-Based Pelvic Floor Muscle Training for Dysfunctional Voiding in Children: A Randomized Clinical Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 2, 2025
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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