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

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

Interventions

OTHER

Exercise

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.

OTHER

Biofeedback

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.

Sponsors & Collaborators

• Inonu University

  lead OTHER

Principal Investigators

• Sinem Suner Keklik, Assoc. Prof. · Cumhuriyet University

• Ahmet Taner Elmas, Prof. · İnönü University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-20

Primary Completion

2023-02-03

Completion

2023-02-06

Countries

• Turkey (Türkiye)

Study Locations