Pelvic Floor Muscle Training and Dynamic Neuromuscular Stabilization Exercises in Pediatric Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-18
SponsorNecmettin Erbakan University

About this trial

Dysfunctional voiding (DY) is one of the most common conditions in children. Various treatments are available. Participants will be randomly assigned to either PFMT (Group I) or PFMT+DNS (Group II). PFMT is the gold standard and routinely administered in hospitals for children diagnosed with dysfunctional voiding who are referred by a urologist. The PFMT group serves as the control group, and treatment will be scheduled for a total of 10 weeks, three days a week. During PFMT, children receive instruction about the pelvic floor using video visuals and increase awareness of their pelvic floor muscles. They are then instructed on how to contract and relax their muscles to control urination. DNS training is an exercise model that begins with spinal stabilization and addresses muscle synergies. Patients included in the study will be evaluated twice, at the beginning and at the end of the treatment: Voiding Disorders Symptom Score (VODS), Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0), Pediatric Incontinence Questionnaire (PIN-Q), Bladder Bowel Dysfunction Scale (BDS), Bristol gaita scale, and Children's Body Image Scale.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Having been diagnosed with voiding dysfunction according to ICCS diagnostic criteria in a urology outpatient clinic,

Being 5-18 years old,

The child and their parent/guardian agree to participate in the study voluntarily and provide signed consent.

Disqualifiers

Organic pathologies such as urethral obstruction, ectopic ureter, spinal dysraphism, and diabetes

Diagnosis of VUR or neurogenic bladder

Cognitive and mental impairment

Having spina bifida

Trial design

Design model

Parallel

Treatments tested in this trial

  • PFMT

    Behavioral

    During PFMT, children are taught about the pelvic floor using video visuals and their awareness of the pelvic floor muscles is increased. They are then instructed on how to contract and relax their muscles to control urination. DNS exercises, on the other hand, is an exercise model that begins with spinal stabilization and focuses on muscle synergies. Participants in the study will be assessed twice: at the beginning and end of treatment, using the Voiding Disorders Symptom Score (VDSS), Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0), the Bladder and Bowel Dysfunction Scale (BBS), Pediatric Incontinence Questionnaire (PIN-Q), Bristol gaita scale, Children's Depression Scale (CDS) and the Children's Body Image Scale.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Pelvic Floor Muscle Training group (PFMT)Active comparator 1 intervention
Group B: PFMT+DNS groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Voiding Disorders Symptom Scoring (VDSS)

There are 13 questions about lower urinary tract symptoms and 1 question about quality of life. Regarding nocturnal enuresis, the frequency and severity of nocturnal enuresis are questioned. The total score ranges from 0 to 35 points, with higher scores indicating greater symptom severity.

Time frame
10 week
2

Bladder and Bowel Dysfunction Scale (BBDS)

The BBDS assesses the severity of bladder and bowel dysfunction symptoms in children. It comprises 14 items, with the first 13 evaluating symptom severity and the last item assessing questionnaire completion difficulty. Each item uses a 5-point Likert scale; higher scores reflect greater symptom severity. Turkish validity and reliability have been confirmed.

Time frame
10 week

Secondary outcomes

1

Pediatric Quality of Life Questionnaire (PEDSQL)

It consists of 23 items and four subsections. It covers physical health, emotional, social, and school functioning. Each item receives a raw score between 0 and 4. "0" = No problem, "1" = Almost no problem, "2" = Sometimes a problem, "3" = Usually a problem, and "4" = Almost always a problem. The resulting raw scores are rescored to range from 0 to 100 (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0). A higher total score indicates a higher quality of life.

Time frame
10 week
2

Children's Body Image Scale

Body image will be measured using the Children's Body Image Scale. The scale has separate versions for boys and girls. The scale contains seven gender-specific images in anatomical positions. Each version includes seven male and seven female photos in the scale. Each photo represents a different BMI range. The images are ranked from A to G according to increasing BMI. Children will be asked to mark the image that best reflects their perceived body size and shape. The calculation will be made by subtracting the number equivalent to their actual BMI from the perceived number. The score range is from -6 to +6, with negative scores indicating a perception of self as smaller than they actually are, zero indicating a correct answer, and positive scores indicating a perception of self as overweight.

Time frame
10 week
3

Depression Scale for Children

Children's depression levels were assessed using the Children's Depression Scale, developed by Kovacs in 1981. The scale is applicable to children aged 6-17. Its validity and reliability in Turkish were demonstrated by Öy (1991). The scale consists of 27 items and has three different response options for each item. In our study, children were asked to think back over the past two weeks and select the sentence that best fits them. Each sentence set includes statements related to symptoms of childhood depression (e.g., sleep and appetite problems, dysphoria). Each sentence set can be scored between 0 and 2. Possible responses for each sentence set are "1. I sometimes feel sad," "2. I often feel sad," and "3. I always feel sad." The maximum score is 54. Higher scores indicate greater depression severity.

Time frame
10 week
4

Pediatric Incontinence Questionnaire (PIN-Q)

The PIN-Q evaluates psychosocial functioning in children and adolescents with continence disorders, covering self-esteem, family and peer relationships, and mood . The scale consists of 20 items; higher total scores indicate worse quality of life.

Time frame
10 week

Other outcomes

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