Investigation of the Effectiveness of Different Interventions for Lower Urinary Tract Symptoms

NCT06399887 | Completed

• 1 other identifier: 2022-06/12
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Lower urinary tract dysfunction (LUTD) is present in 2-40% of healthy children. If left untreated, it can lead to health problems such as recurrent urinary tract infections, vesicoureteral reflux and chronic renal failure. Pelvic floor physiotherapy is a globally accepted treatment for adults and children. In addition to locomotor skills, functional exercises such as motor control, core stability and balance training are important to support toilet training. Dynamic Neuromuscular Stabilization (DNS), a current stabilization approach, is a neurophysiological rehabilitation strategy based on developmental kinesiology, using ontogenetic models to both diagnose and treat dysfunction in the locomotor system in infants and adult patients. Today, DNS is successfully used in the rehabilitation of various neurological, musculoskeletal, pediatric and sports injuries. However, there are no studies in the literature examining the effectiveness of DNS training in children diagnosed with LUTD. The aim of this study was to evaluate the effectiveness of DNS training in children diagnosed with LUTD and to compare it with EMG-Biofeedback treatment method. The children participating in the study will be randomly divided into 3 groups. Children in Group I will exercise 3 days a week for 45 minutes according to DNS principles. Children in Group II will receive EMG Biofeedback training 1 day a week. Children in Group III will receive EMG-Biofeedback training 1 day a week in addition to exercises with DNS principles 3 days a week. In the study, data on symptoms, demographic data of the individuals before treatment and at 4th week, 8th week and 12th week after treatment will be obtained from each child participating in the study through a questionnaire, symptoms related to voiding disorder and urinary incontinence with Dysfunctional Voiding and Incontinence Scoring System (DVISS), activation of deep trunk muscles with Stabilizer Pressure Biofeedback Unit, urine flow curve and voiding parameters of the patients with uroflowmeter application will be evaluated. Kruskal-Wallis analysis of variance will be used to compare the three groups in terms of variables. Wilcoxon signed-rank test will be used to analyze the statistical significance of the difference between all values before and after treatment. For all results, p\<0.05 will be considered as significance level.

Conditions

Lower Urinary Tract Symptoms; Biofeedback; Pelvic Floor

Keywords

Children; lower urinary tract dysfunction; dynamic neuromuscular stabilization; biofeedback; pelvic floor rehabilitation

Outcome Measures

Primary Outcomes (9)

• Lower urinary tract symptom score

  The DVISS recommended by the ICCS will be used for the evaluation of lower urinary tract function. This questionnaire, which has Turkish validity and reliability, consists of 13 symptoms and 1 quality of life question. The total score varies between 0 and 35. An increase in the total score indicates an increase in symptoms. It has a cut-off value of 8.5 and 90% specificity and sensitivity in detecting the presence of bladder bowel dysfunction and LUTD.

  12 weeks

• Post-voiding residual urine

  PVR and rectal diameter assessment of the children will be performed by the same person in the same unit with a Logiq P9 USG Device (GE Healthcare, USA) within the first 5 minutes after the UFM test. Pelvic USG is performed with a 5 mHz low frequency convex USG probe. The convex probe is placed 1-2 cm above the symphysis pubis and images of the bladder are taken in the transverse and sagittal axes. PVR will be calculated using the ellipsoid formula based on measurements of the bladder at its maximal diameters as follows: anteroposterior diameter x transverse diameter x longitudinal diameter x 0.52. For children aged 4-6 years, a single PVR \>30 ml or \>21% of BC, repeat PVR \>20 ml or \>10% of BC; for children aged 7-12 years, a single PVR \>20 ml or \>15% of BC, repeat PVR \>10 ml or \>6% of BC is considered significantly high.

  12 weeks

• Flow curve type

  The urine flow curve will be interpreted by a pediatric nephrologist according to the pattern of the curve obtained from the voiding test. According to ICCS recommendations, five different types of voiding curves can be seen on the uroflowmeter. These are bell, tower, plateau, staccato and fractional and only the bell-shaped voiding curve is considered normal. The presence or absence of these parameters and voiding curves within normal limits provides important objective information about voiding dysfunctions.

  12 weeks

• Deep trunk muscle strength

  Assessment of the deep trunk muscles, especially the Transversus Abdominis (TrA) and deep neck flexors (DNF) will be performed using the Stabilizer Pressure Biofeedback Unit (Chattanooga Stabilizer).

  12 weeks

• Voiding volume

  Voiding volume, one of the uroflowmeter parameters, will be performed using the Intelligent System UFM Device (Serial No: 18020004-02) (Uroscan Plus Inoflow Intelligent UFM Device, Aymed, Medical Technology, Turkey).

  12 weeks

• Voiding time

  Voiding time, one of the uroflowmeter parameters, will be performed using the Intelligent System UFM Device (Serial No: 18020004-02) (Uroscan Plus Inoflow Intelligent UFM Device, Aymed, Medical Technology, Turkey).

  12 weeks

• Maximum flow rate

  Maximum flow rate, one of the uroflowmeter parameters, will be performed using the Intelligent System UFM Device (Serial No: 18020004-02) (Uroscan Plus Inoflow Intelligent UFM Device, Aymed, Medical Technology, Turkey).

  12 weeks

• Time to reach maximum flow

  Time to reach maximum flow, one of the uroflowmeter parameters, will be performed using the Intelligent System UFM Device (Serial No: 18020004-02) (Uroscan Plus Inoflow Intelligent UFM Device, Aymed, Medical Technology, Turkey).

  12 weeks

• Average flow rate

  Average flow rate, one of the uroflowmeter parameters, will be performed using the Intelligent System UFM Device (Serial No: 18020004-02) (Uroscan Plus Inoflow Intelligent UFM Device, Aymed, Medical Technology, Turkey).

  12 weeks

Study Arms (3)

Group I : Dynamic neuromuscular stabilization exercise training

ACTIVE COMPARATOR

Group I • dynamic neuromuscular stabilization exercise training * 45 minute/ 3 sessions/ week * 12 weeks

Other: Exercise

Group II : Biofeedback training

ACTIVE COMPARATOR

Group II • biofeedback training * 20 minute/ 1 sessions/ week * 12 weeks

Other: Biofeedback

Group III : Dynamic neuromuscular stabilization exercise training + biofeedback training

ACTIVE COMPARATOR

Group III * dynamic neuromuscular stabilization exercise training * 45 minute/ 3 sessions/ week * 12 weeks * biofeedback training * 20 minute/1 sessions/week * 12 weeks

Other: Exercise; Other: Biofeedback

Interventions

Exercise OTHER

All patients in these groups are taught diaphragmatic breathing, which is the basis for DNS, and are asked to maintain it throughout the exercises. The DNS protocol includes a 5-minute warm-up, 40 minutes of DNS exercises (10 minutes for each of the 4 different body parts) and breathing exercises. The DNS exercises included diaphragmatic breathing, Baby Rock, Roll Over, Lying on the Side, Sitting Down, Sitting Upright, Tripod, Kneeling, Squatting, Prone, and Pull Up (CGU). The focus of the first week is to teach and practice basic DNS exercises.

Group I : Dynamic neuromuscular stabilization exercise training; Group III : Dynamic neuromuscular stabilization exercise training + biofeedback training

Biofeedback OTHER

Patients in Group II and Group III will be trained in animated CP using the Aymed Medical Locum Wireless System v.2.69.0.12 device. During CP, 10-second contraction and 30-second relaxation cycles are maintained throughout the animated game. Each session will last approximately 20 minutes. The training protocol will consist of a total of 12 sessions of 20 minutes per week for 3 months.

Group II : Biofeedback training; Group III : Dynamic neuromuscular stabilization exercise training + biofeedback training

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- Normal growth and development,
• Absence of a known psychological or behavioural disorder and interactive communication problems or chronic drug use related to these diseases.
• Normal mental, motor development, and neurological examination findings without any neuro-motor system abnormalities,
• Absence of any current and/or past congenital anomalies and abnormal ultrasonography (USG) examination findings in the kidney and urinary tract,
• Dysfunctional Voiding and Incontinence Symptoms Score Questionnaire (DVISS) score above 8.5 points

You may not qualify if:

• \- Skin findings that may be related to occult spinal dysraphism in the lumbosacral region examination,
• In the uroflowmetry (UFM) test;
• Voided volume (VV) is less than 100 mL and/or below 50% or above 115% of expected bladder capacity (EBC)

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Department of Pediatric Nephrology, Inonu University Faculty of Medicine, Turgut Özal Medical Center

Malatya, 444000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Interventions

Exercise; Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Sinem Suner Keklik, Assoc. Prof.

  Cumhuriyet University

  STUDY DIRECTOR

• Ahmet Taner Elmas, Prof.

  İnönü University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: May 6, 2024
• Study Start: October 20, 2022
• Primary Completion: February 3, 2023
• Study Completion: February 6, 2023
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)