- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07267364
Pelvic Floor Muscle Training and Dynamic Neuromuscular Stabilization Exercises in Pediatric Patients
April 30, 2026 updated by: Saliha Özer, Necmettin Erbakan University
Effects of Adding Dynamic Neuromuscular Stabilization to Pelvic Floor Muscle Training on Voiding Dysfunction in Children: A Randomized Controlled 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.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Konya
-
Konya, Konya, Turkey (Türkiye), (507) 534-6142
- Recruiting
- Necmettin Erbakan University
-
Contact:
- Hanife 39718 Doğan, Assoc.Prof.
- Phone Number: +905075346142
- Email: hanife_dogan@yahoo.com.tr
-
Konya, Konya, Turkey (Türkiye)
- Recruiting
- Hanife Dogan
-
Contact:
- Hanife Dogan
- Phone Number: +905075346142
- Email: hanife_dogan@yahoo.com.tr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
Other Names:
|
|
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Voiding Disorders Symptom Scoring (VDSS)
Time Frame: 10 week
|
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.
|
10 week
|
|
Bladder and Bowel Dysfunction Scale (BBDS)
Time Frame: 10 week
|
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.
|
10 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pediatric Quality of Life Questionnaire (PEDSQL)
Time Frame: 10 week
|
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.
|
10 week
|
|
Children's Body Image Scale
Time Frame: 10 week
|
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.
|
10 week
|
|
Depression Scale for Children
Time Frame: 10 week
|
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.
|
10 week
|
|
Pediatric Incontinence Questionnaire (PIN-Q)
Time Frame: 10 week
|
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.
|
10 week
|
|
Pelvic Floor Muscle strength and endurance
Time Frame: 10 week
|
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
|
10 week
|
|
Bristol gaita scale
Time Frame: 10 week
|
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
|
10 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 11, 2025
Primary Completion (Actual)
February 1, 2026
Study Completion (Estimated)
April 30, 2026
Study Registration Dates
First Submitted
November 18, 2025
First Submitted That Met QC Criteria
December 4, 2025
First Posted (Actual)
December 5, 2025
Study Record Updates
Last Update Posted (Actual)
May 4, 2026
Last Update Submitted That Met QC Criteria
April 30, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23743.R1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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