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

Effects of Adding Dynamic Neuromuscular Stabilization to Pelvic Floor Muscle Training on Voiding Dysfunction in Children: A Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07267364
Enrollment
48
Registered
2025-12-05
Start date
2025-11-11
Completion date
2026-03-30
Last updated
2026-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urology, Pediatric Disorder

Keywords

Voiding dysfunction, pelvic floor muscle training, neuromuscular stabilization, quality of life

Brief summary

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.

Interventions

BEHAVIORALPFMT

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.

Sponsors

Necmettin Erbakan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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 * Being under 5 years of age * Receiving treatment such as PTC training or electrical stimulation

Design outcomes

Primary

MeasureTime frameDescription
Voiding Disorders Symptom Scoring (VDSS)10 weekThere 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.
Bladder and Bowel Dysfunction Scale (BBDS)10 weekThe 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.

Secondary

MeasureTime frameDescription
Pediatric Quality of Life Questionnaire (PEDSQL)10 weekIt 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.
Children's Body Image Scale10 weekBody 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.
Depression Scale for Children10 weekChildren'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.
Pediatric Incontinence Questionnaire (PIN-Q)10 weekThe 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.
Pelvic Floor Muscle strength and endurance10 weekAll participants received standardized PFMT supported by EMG-biofeedback (NeuroTrac Myoplus 4, Verity Medical Ltd, UK). Prior to training, children were provided with age-appropriate education on pelvic floor anatomy, bladder-bowel function, and voiding physiology using visual and interactive materials. The relationship between symptoms and daily life, including psychosocial aspects, was also explained to enhance understanding and adherence
Bristol gaita scale10 weekStool type was assessed using the Bristol Stool Scale, which classifies stool into 7 groups. Type 1 is the hardest and most fragmented stool, while Type 7 becomes watery stool with no solid content. The shape of the stool changes depending on its residence time in the colon

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026