ClinicalTrials.Veeva

Menu

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

D

Damla Korkmaz Dayican

Status

Enrolling

Conditions

Pelvic Floor Disorders
Daytime Wetting
Pediatric Disorder
Children, Only
Nocturnal Enuresis
Urinary Incontinence

Treatments

Other: multimodal pelvic floor rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT06231394
T-DAYICAN-001

Details and patient eligibility

About

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.

Enrollment

51 estimated patients

Sex

All

Ages

5 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Being between the ages of 5-18
  • Having been diagnosed with urinary incontinence according to the International Children's Continence Society criteria by a pediatric urologist (daytime incontinence, nocturnal enuresis, combined daytime incontinence and nocturnal enuresis)
  • Signed the informed consent form
  • Parent or child's ability to read and write Turkish

Exclusion criteria

  • Presence of neurogenic lower urinary tract dysfunction
  • Presence of anatomical changes and malformations in the urinary system
  • Presence of active urinary system infection
  • Having previously undergone surgery to treat urinary incontinence
  • The child has any condition that would prevent participation in assessment or treatment (cognitive impairment, mental retardation, orthopedic disease or surgery, etc.)
  • Presence of congenital thorax deformity
  • The child has received pelvic floor rehabilitation within the last six months

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

51 participants in 3 patient groups

daytime incontinence
Active Comparator group
Description:
This group will consist of participants who will be diagnosed with daytime incontinence by a pediatric urologist according to the International Children's Continence Society criteria.
Treatment:
Other: multimodal pelvic floor rehabilitation
nocturnal enuresis
Active Comparator group
Description:
This group will consist of participants who will be diagnosed with nocturnal enuresis by a pediatric urologist according to the International Children's Continence Society criteria.
Treatment:
Other: multimodal pelvic floor rehabilitation
combined daytime incontinence and nocturnal enuresis
Active Comparator group
Description:
This group will consist of participants who will be diagnosed with combined daytime incontinence and nocturnal enuresis by a pediatric urologist according to the International Children's Continence Society criteria.
Treatment:
Other: multimodal pelvic floor rehabilitation

Trial contacts and locations

1

Loading...

Central trial contact

Damla Korkmaz Dayican

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems