NCT07267364

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

November 18, 2025

Last Update Submit

April 30, 2026

Conditions

Keywords

Voiding dysfunctionpelvic floor muscle trainingneuromuscular stabilizationquality of life

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    10 week

Secondary Outcomes (6)

  • Pediatric Quality of Life Questionnaire (PEDSQL)

    10 week

  • Children's Body Image Scale

    10 week

  • Depression Scale for Children

    10 week

  • Pediatric Incontinence Questionnaire (PIN-Q)

    10 week

  • Pelvic Floor Muscle strength and endurance

    10 week

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: PFMT

Interventions

PFMTBEHAVIORAL

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
PFMT+DNS groupPelvic Floor Muscle Training group (PFMT)

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Necmettin Erbakan University

Konya, Konya, (507) 534-6142, Turkey (Türkiye)

RECRUITING

Hanife Dogan

Konya, Konya, Turkey (Türkiye)

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physıcal Therapy and Rehabilitation

Study Record Dates

First Submitted

November 18, 2025

First Posted

December 5, 2025

Study Start

November 11, 2025

Primary Completion

February 1, 2026

Study Completion

April 30, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations