UrologyNCT07267364
Pelvic Floor Muscle Training and Dynamic Neuromuscular Stabilization Exercises in Pediatric Patients
A study testing PFMT in people with Urology and Pediatric Disorder, run by Necmettin Erbakan University at 2 sites in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Urology, Pediatric Disorder
- What is being tested?
- PFMT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 11 Nov 2025to 3 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Necmettin Erbakan University
Konya, Konya, (507) 534-6142
Hanife 39718 Doğan, Assoc.Prof., +905075346142, hanife_dogan@yahoo.com.tr
- Recruiting
Hanife Dogan
Konya, Konya
Hanife Dogan, +905075346142, hanife_dogan@yahoo.com.tr
About this study
Official title: 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.
- Conditions
- Urology, Pediatric Disorder
- Being tested
- PFMT
- Keywords
- Voiding dysfunction, pelvic floor muscle training, neuromuscular stabilization, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFMTBehavioural
Also called PFMT+DNS
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.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Floor Muscle Training group (PFMT) | Active comparator | 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. Receives: Behavioral: PFMT |
| PFMT+DNS group | Active comparator | 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. Receives: Behavioral: PFMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 week
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.
Measured: 10 week
Secondary outcomes (6)
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.
Measured: 10 week
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.
Measured: 10 week
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.
Measured: 10 week
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.
Measured: 10 week
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
Measured: 10 week
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
Measured: 10 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start11 Nov 2025
- Primary completion1 Feb 2026
- Study completion3 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrologyStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saliha Özer, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267364
- Sponsor's protocol ID
- 23743.R1
- Status last verified
- Oct 2026
- First submitted
- 18 Nov 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adding Dynamic Neuromuscular Stabilization to Pelvic Floor Muscle Training on Voiding Dysfunction in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07267364
- Acronym / sponsor ID
- 23743.R1
- Conditions
- Urology, Pediatric Disorder
- Keywords
- Voiding dysfunction, pelvic floor muscle training, neuromuscular stabilization, quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 3 Oct 2026 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic Floor Muscle Training group (PFMT) | Active comparator | Behavioral: PFMTChildren 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. |
| PFMT+DNS group | Active comparator | Behavioral: PFMTIn 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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PFMTAlso: PFMT+DNSDuring 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. | Behavioural | PFMT+DNS group, Pelvic Floor Muscle Training group (PFMT) |
Primary outcome
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.
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.
6 secondary outcomes
Pediatric Quality of Life Questionnaire (PEDSQL)
Time frame: 10 week
Children's Body Image Scale
Time frame: 10 week
Depression Scale for Children
Time frame: 10 week
Pediatric Incontinence Questionnaire (PIN-Q)
Time frame: 10 week
Pelvic Floor Muscle strength and endurance
Time frame: 10 week
Bristol gaita scale
Time frame: 10 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PFMT in people with Urology and Pediatric Disorder, run by Necmettin Erbakan University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voiding Disorders Symptom Scoring (VDSS) (time frame: 10 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.