NCT06231394

Effectiveness of Multimodal Pelvic Floor Rehabilitation Program in Children With Different Types of Urinary Incontinence

Status unknown NA Last updated 5 March 2024

What this trial tests

NA trial testing multimodal pelvic floor rehabilitation in Urinary Incontinence in 51 participants. Status unknown.

Timeline

1 February 2024

Primary endpoint
1 October 2024

1 February 2025

Quick facts

Lead sponsor	Damla Korkmaz Dayican
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	51
Start date	1 February 2024
Primary completion	1 October 2024
Estimated completion	1 February 2025
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• multimodal pelvic floor rehabilitation

Conditions studied

• Urinary Incontinence — all drugs for Urinary Incontinence →
• Nocturnal Enuresis — all drugs for Nocturnal Enuresis →
• Daytime Wetting — all drugs for Daytime Wetting →
• Pelvic Floor Disorders — all drugs for Pelvic Floor Disorders →

Sponsor

Damla Korkmaz Dayican

Who can join

Adults 5 to 18, any sex, with Urinary Incontinence or Nocturnal Enuresis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Urinary incontinence is defined by the International Children's Continence Society as involuntary urinary leakage that can be continuous or intermittent in children aged five and over. Urinary incontinence is divided into subgroups of daytime incontinence, nocturnal enuresis and combined daytime incontinence and nocturnal enuresis. Different pelvic floor rehabilitation programs appear to be effective in children with daytime incontinence and nocturnal enuresis but mostly focus on the pelvic floor muscle training component. However, pelvic floor rehabilitation includes many components such as education, lifestyle changes, manual techniques, pelvic floor muscle training, functional exercises, biofeedback therapy, electrical stimulation and home program. However, there is no study examining the effectiveness of a multimodal pelvic floor rehabilitation program in the treatment of children with urinary incontinence. It is also unclear for which urinary incontinence type the multimodal pelvic floor rehabilitation program will be more effective. Therefore, investigators aim to compare the effects of a multimodal pelvic floor rehabilitation program on lower urinary tract symptoms, pelvic floor muscles and other related muscle functions in children with different urinary incontinence types. Children between the ages of 5 and 18 who were diagnosed with urinary incontinence by applying to Ege University Faculty of Medicine, Department of Pediatric Urology will be included in the study. Participants will be divided into three groups: daytime incontinence, nocturnal enuresis, and combined daytime incontinence and nocturnal enuresis. A multimodal pelvic floor rehabilitation program will be performed on all children for 10 weeks, two days a week and approximately 45 minutes. A multimodal pelvic floor rehabilitation program will include education, bladder and bowel training, manual techniques, exercise training (diaphragmatic breathing exercise, pelvic floor muscle training, trunk stabilization exercises based on developmental kinesiology) and a home program. Children's lower urinary symptoms will be assessed with the Dysfunctional Voiding and Incontinence Scoring System, Bladder and Bowel Dysfunction Questionnaire, Childhood Bladder and Bowel Dysfunction Questionnaire, bladder and bowel diary, and the functions of the pelvic floor muscles and other related muscles will be assessed with superficial electromyography and ultrasonography.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.