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

Tanta University

Status: Enrolling

Conditions: Dysfunctional Voiding; Children; Medical Treatment; Biofeedback

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07149532

36264PR1112/2/25

Details and patient eligibility

About

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

Full description

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.

Enrollment: 124 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

Group 1

Active Comparator group

Description:

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

Treatment:

Other: Biofeedback-based pelvic floor muscle training

Group 2

Experimental group

Description:

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

Treatment:

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