Clinical trial NCT06231394: Effectiveness of Multimodal Pelvic Floor Rehabilitation Program in Children With Different Types of Urinary Incontinence
Official title: Effectiveness of Multimodal Pelvic Floor Rehabilitation Program in Children With Different Types of Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urinary Incontinence
Nocturnal Enuresis
Daytime Wetting
Pelvic Floor Disorders
Children, Only
Pediatric Disorder
Keywords: urinary incontinence
nocturnal enuresis
daytime incontinence
pediatric
pelvic floor rehabilitation
Lead sponsor: Izmir Tinaztepe University
Sponsor class: OTHER
Collaborators: name: Biruni University
name: Dokuz Eylul University
First posted: 2024-01-30
Enrollment: 51
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Dysfunctional Voiding and Incontinence Scoring System (DVAISS)
timeFrame: pre-intervention; immediately after the intervention
measure: Bladder and Bowel Dysfunction Questionnaire (BBDQ)
timeFrame: pre-intervention; immediately after the intervention
measure: Childhood Bladder and Bowel Dysfunction Questionnaire (CBBDQ)
timeFrame: pre-intervention; immediately after the intervention
measure: Bladder Diary
timeFrame: pre-intervention; immediately after the intervention
measure: Bowel Diary
timeFrame: pre-intervention; immediately after the intervention
Secondary outcomes:
measure: Superficial Electromyography (EMG)
timeFrame: pre-intervention; immediately after the intervention
measure: Ultrasonography (USG)
timeFrame: pre-intervention; immediately after the intervention
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University Faculty of Medicine, Department of Pediatric Urology
state: Bornova
Study officials:
affiliation: Fenerbahçe University
name: Arzu Razak Özdinçler
role: STUDY_DIRECTOR
affiliation: İzmir Tınaztepe University
name: Damla Korkmaz Dayıcan
role: PRINCIPAL_INVESTIGATOR
affiliation: Dokuz Eylul University
name: Özge Çeliker Tosun
role: PRINCIPAL_INVESTIGATOR
affiliation: Dokuz Eylul University
name: Büşra Palaz
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University
name: İbrahim Ulman
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University
name: Ali Tekin
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University
name: Sibel Tiryaki
role: PRINCIPAL_INVESTIGATOR
References: