New Generation Rehabilitation Approach in Children With Dysfunctional Voiding

NCT ID: NCT06743165

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2026-06-01

Brief Summary

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The investigators hypothesize that Dynamic Neuromuscular Stabilization training, a next-generation exercise approach, and transabdominal ultrasound-guided pelvic floor muscle training (PFMT) will be more effective than PFMT guided solely by transabdominal ultrasound in reducing post-void residual volume, improving voiding disorder symptoms, and enhancing pelvic floor muscle relaxation in children with dysfunctional voiding.

Detailed Description

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Conditions

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Dysfunctional Voiding Children Pelvic Floor Muscle Training Ultrasound DNS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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DNS Group

This group includes 18 children with Dysfunctional voiding, aged between 6 and 14 years.

Group Type EXPERIMENTAL

Pelvic floor muscle training with ultrasound biofeedback

Intervention Type BEHAVIORAL

Pelvic floor muscle training (PFMT) will be given to both groups with transabdominal US. PFMT will be applied by physiotherapists who have received training and supervision from physiotherapists who are experts in the field of pelvic floor US imaging and pelvic floor muscle training with US. Pelvic floor muscle training will be applied with a GE Brand LOGIQ P8 model transabdominal ultrasound (GE HealthCare) US device under the supervision of an expert physiotherapist. Parents and children will be informed about PFMT.

Dynamic neuromuscular stabilization exercise

Intervention Type BEHAVIORAL

Dynamic neuromuscular exercises (DNS) involve the joint activation of the intrinsic muscle group of the spine, which includes the cervical flexors and extensors, diaphragm, transversus abdominis, multifidus and pelvic floor, which form the integrated spinal stabilization system. The application principles are joint centering, core stabilization - Integrated spinal stabilization system and stabilization function of the diaphragm. DNS training will be applied in three stages. Preparation for exercises, IAB regulation and application of exercises according to developmental kinesiology positions. Exercises will start with preparatory training. In preparatory training, stroking, brushing and tapping techniques will be taught and self-facilitation will be demonstrated in order to increase proprioceptive input to the lower extremity, upper extremity, trunk and pelvic region. Fascial mobilizations will be performed to the foot and hand regions.

Standard exercise group

This group includes 18 children with Dysfunctional voiding, aged between 6 and 14 years.

Group Type ACTIVE_COMPARATOR

Pelvic floor muscle training with ultrasound biofeedback

Intervention Type BEHAVIORAL

Pelvic floor muscle training (PFMT) will be given to both groups with transabdominal US. PFMT will be applied by physiotherapists who have received training and supervision from physiotherapists who are experts in the field of pelvic floor US imaging and pelvic floor muscle training with US. Pelvic floor muscle training will be applied with a GE Brand LOGIQ P8 model transabdominal ultrasound (GE HealthCare) US device under the supervision of an expert physiotherapist. Parents and children will be informed about PFMT.

Interventions

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Pelvic floor muscle training with ultrasound biofeedback

Pelvic floor muscle training (PFMT) will be given to both groups with transabdominal US. PFMT will be applied by physiotherapists who have received training and supervision from physiotherapists who are experts in the field of pelvic floor US imaging and pelvic floor muscle training with US. Pelvic floor muscle training will be applied with a GE Brand LOGIQ P8 model transabdominal ultrasound (GE HealthCare) US device under the supervision of an expert physiotherapist. Parents and children will be informed about PFMT.

Intervention Type BEHAVIORAL

Dynamic neuromuscular stabilization exercise

Dynamic neuromuscular exercises (DNS) involve the joint activation of the intrinsic muscle group of the spine, which includes the cervical flexors and extensors, diaphragm, transversus abdominis, multifidus and pelvic floor, which form the integrated spinal stabilization system. The application principles are joint centering, core stabilization - Integrated spinal stabilization system and stabilization function of the diaphragm. DNS training will be applied in three stages. Preparation for exercises, IAB regulation and application of exercises according to developmental kinesiology positions. Exercises will start with preparatory training. In preparatory training, stroking, brushing and tapping techniques will be taught and self-facilitation will be demonstrated in order to increase proprioceptive input to the lower extremity, upper extremity, trunk and pelvic region. Fascial mobilizations will be performed to the foot and hand regions.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Children aged 6-14 years,
* Diagnosed with dysfunctional urination according to uroflowmetry measurement results and clinical examination findings,
* Children who consent to participate in the study with the consent of their mother, father or legal guardian (legal representative) will be included in the study.

Exclusion Criteria

* Children under 6 years of age,
* Those with anatomical changes in the urinary system,
* Those with spina bifida,
* Those with a history of active urinary tract infection,
* Those with a neurological disease,
* Those with accompanying respiratory system disease,
* Those with cognitive impairment,
* Those with mental retardation,
* Children whose bladder image is unclear in the pelvic floor evaluation with US,
* Children who have previously undergone orthopedic surgery will not be included in the study.

PS:

* Children who cannot comply with the application of pelvic floor muscle training,
* Children who have missed 2 or more sessions of the treatment program will be excluded from the study.
Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Health Institutes of Turkey

OTHER_GOV

Sponsor Role collaborator

Izmir University of Economics

OTHER

Sponsor Role lead

Responsible Party

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Seda Yakit Yesilyurt

Assist. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Izmir University of Economics

Izmir, İzmir, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Seda Yakıt Yeşilyurt, Asst. Prof.

Role: CONTACT

+902324888439

Facility Contacts

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Seda Yakıt Yeşilyurt

Role: primary

+902324888439

Other Identifiers

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SYY_IEU_4

Identifier Type: -

Identifier Source: org_study_id

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