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RecruitingNCT07267364Updated Oct 6, 2026

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

An interventional study of PFMT in Urology and Pediatric Disorder, sponsored by Necmettin Erbakan University. Recruiting at 2 sites in Turkey (Türkiye). Open to participants aged 5 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Necmettin Erbakan University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2025; still recruiting 1 year later.
Updated Oct 6, 2026Study completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
5 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Urology
  • Pediatric Disorder

Keywords

  • Voiding dysfunction
  • pelvic floor muscle training
  • neuromuscular stabilization
  • quality of life
03

In context

Lead sponsor

Necmettin Erbakan University is the lead sponsor of 201 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
48 participants (estimated)

Study arms

  • Active comparator
    Pelvic Floor Muscle Training group (PFMT)

    Children diagnosed with dysfunctional voiding will receive pelvic floor training using superficial video visuals, and pelvic muscle strength and endurance will be increased with EMG and biofeedback. Exercises will be administered three days a week for ten weeks. They will be assessed before and after treatment with the Voiding Disorders Symptom Score (VDSS), Children's Depression Scale, Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0), Bladder and Bowel Dysfunction Scale (BDS), Pediatric Incontinence Questionnaire (PIN-Q), Bristol gaita scale, and the Children's Body Image Scale.

    Behavioral: PFMT

  • Active comparator
    PFMT+DNS group

    In addition to PFME, an exercise model that begins with Dynamic Neuromuscular Stabilization (DNS) spine stabilization and addresses muscle synergies will be applied for 10 weeks. hey will be assessed before and after treatment with the Voiding Disorders Symptom Score (VDSS), the Children's Depression Scale,Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0), the Bladder and Bowel Dysfunction Scale (BDS), Pediatric Incontinence Questionnaire (PIN-Q), Bristol gaita scale,and the Children's Body Image Scale.

    Behavioral: PFMT

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.

    Also known as: PFMT+DNS

06

What researchers measure

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

  5. Pelvic Floor Muscle strength and endurance

    All 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

    Time frame: 10 week

  6. Bristol gaita scale

    Stool 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

    Time frame: 10 week

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Study completion
Aug 21, 2026→Oct 3, 2026
Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Study completion Aug 21, 2026→Oct 3, 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07267364
Responsible party
Saliha Özer (Physıcal Therapy and Rehabilitation, Necmettin Erbakan University) — Principal investigator
First posted
Dec 5, 2025
Start date
Nov 11, 2025
Primary completion
Feb 1, 2026
Completion
Oct 3, 2026 (estimated)
Last update
Oct 6, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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