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

Lower Urinary Tract Symptoms Clinical Trial

Official title:

Evaluation of the Effectiveness of Dynamic Neuromuscular Stabilization Training in Children With Lower Urinary Tract Dysfunction: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06399887
• Other study ID #: 2022-06/12
• Status: Completed
• Phase: N/A
• Start date: October 20, 2022
• Est. completion date: February 6, 2023

Study information

• Verified date: May 2024
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The sample of the study will consist of children between the ages of 6-15 years who were admitted to Malatya Inönü University Turgut Özal Medical Center Pediatric Urodynamics/Urotherapy Unit and diagnosed with LUTD by a pediatric nephrology specialist. Inclusion criteria: Being between the ages of 6-15 years, having a normal neurologic examination, being diagnosed with LUTD, having a DVISS of 8.5 and above, not having received any medication or other treatment for enuresis before. Exclusion criteria were as follows: patients with primary nocturnal enuresis, patients with uncontrolled systemic disease, patients with neurologic disease (muscle disease, epilepsy, etc.), patients with inflammation of the vagina, anus and urinary tract, patients with febrile illness or active urinary tract infection, presence of underlying psychological causes, presence of mental retardation, inability to comply with treatment. Children who meet the inclusion criteria will be included in the study by non-probability random sampling method. The inclusion of the three clusters formed according to the registration number of the Pediatric Urodynamics/Urotherapy Unit will be determined by lottery method. After the children and their parents/guardians who meet the inclusion criteria are informed about the study content, they will be asked to sign the informed consent forms for the child and the informed consent forms for the parents/guardians if they agree to participate in the study.

The individuals participating in the study will be divided into 3 groups. Children in Group I will exercise according to DNS principles 3 days a week for 12 weeks, with sessions of 45 minutes. Children in Group II will receive animated EMG biofeedback training with the Aymed Medikal Locum Wireless System v.2.69.0.12 device. For animated biofeedback application, two electrodes will be placed at 3 and 9 o'clock in the perineum region and 1 reference electrode will be placed on the inner side of the thigh (42). The training protocol will be applied once a week for a total of 12 sessions for 3 months. In addition to exercises with the DNS principle 3 days a week, the children in Group III will receive biofeedback training with animation once a week with the Aymed Medikal Locum Wireless System v.2.69.0.12 device for a total of 3 months. Demographic data of the individuals participating in the study will be obtained through a questionnaire from each child participating in the study. The questions in the questionnaire are personal information of the child, toilet training age, frequency of urinary tract infections, whether they have received treatment for urinary incontinence before, whether they have chronic constipation, whether their parents have a history of urinary incontinence at a young age and some personal information specific to the parents.

The Dysfunctional Voiding and Incontinence Scoring System (DVISS) will be used for symptoms of voiding dysfunction and urinary incontinence. The DVISS is a 13-item questionnaire. It originally includes 14 questions about symptoms and 1 question about quality of life. In the scoring system developed by Akbal et al. for the pediatric population and adapted to Turkish, there are 13 symptom and 1 quality of life question.

Evaluation of uroflowmeter parameters will be performed with the uroflowmeter application of the Aymed Medikal Locum Wireless System v.2.69.0.12 EMG device and the urine flow curve and voiding parameters of the patients will be evaluated. These parameters are maximum flow rate, time to reach maximum flow, mean flow rate, voiding volume and voiding time. In our study, urine volume of 100 ml or more will be considered valid. Evaluation of deep trunk muscles (transversus abdominis, multifidus and deep neck flexors) will be performed with the Stabilizer Pressure Biofeedback Unit (Chattanooga Stabilizer, USA). Before the test, each participant will be taught how to contract the transversus abdominis muscle with the corset method in the supine and quadripedal position and how to contract the multifidus muscle in the supine position. Measurements will be made for 10 seconds and 3 repetitions, three measurements will be recorded and averaged. For the measurement of the deep neck flexors, the patients will first be taught the correct craniocervical flexion movement without activation of the superficial muscles. The change in pressure will be recorded and the highest value from 3 trials will be taken. Individuals will be evaluated before treatment, at 4 weeks, 8 weeks and 12 weeks after treatment. The aim here is to measure how long it takes to show the effectiveness of the treatment(s) applied and to determine whether the treatments are superior in terms of time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 6, 2023
• Est. primary completion date: February 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

Inclusion Criteria:

• - 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

Exclusion Criteria:

• - 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)

Related Conditions & MeSH terms

• Biofeedback
• Lower Urinary Tract Symptoms
• Pelvic Floor

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Department of Pediatric Nephrology, Inonu University Faculty of Medicine, Turgut Özal Medical Center	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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