Pelvic Floor Muscle Activity, Respiratory Functions, Respiratory Muscle Strength, and Functional Capacity in Children With Lower Urinary Tract Dysfunction

NCT06652178 | Completed

• 1 other identifier: 31.05.2024-152562
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The functional disorders of the lower urinary tract in children involve overactive bladder with thickening of the bladder muscle, resulting in a decrease in functional bladder volume and an increase in intra-bladder pressure. Lower urinary tract dysfunction in children most commonly develops due to non-neuropathic bladder sphincter dysfunction. Pelvic floor disorders is a term used to describe various diseases including mild, moderate and severe impairment of the pelvic floor muscles. Pelvic floor disorders become a condition that causes some symptoms such as involuntary urinary and faecal/gas incontinence, urgency and pelvic pain due to increased pressure of the pelvic floor muscles. Although the symptoms experienced may be permanent, they usually last throughout the day. Electromyography (EMG) is a well-known non-invasive and practical method for relative pelvic floor muscle activity. Standardised endurance tests will be used for core muscle endurance measurements. Pulmonary function tests help to determine the severity of functional impairments and the extent to which treatment restores normal function. It has been reported that respiratory muscle strength tests can be used to monitor the effect of various diseases on muscle strength, especially considering their variations in the normal population. The six-minute walk test, which is used in the assessment of functional capacity, is frequently used in a wide range of different populations, including children, because it is easy to perform, has a low cost and especially shows exercise capacity. The six-minute walk test is an important indicator of aerobic endurance, which is one of the basic components of physical fitness. The findings of this project will provide to see whether pelvic floor muscle activity, respiratory functions, respiratory muscle strength and functional capacity of children with lower urinary tract dysfunction differ from healthy children of the same age. The lack of a study on this subject suggests that this study would be an important contribution to the literature. In the present study, it was aimed to evaluate pelvic floor muscle activity with a superficial EMG device, core strength-endurance with core muscle endurance tests, respiratory functions with a spirometer (pulmonary function test), respiratory muscle strength (MIP/MEP) with an intraoral pressure measuring device, and functional capacity with a six-minute walk test. Determining how lower urinary tract dysfunction affects pelvic floor muscle activity, respiratory functions, respiratory muscle strength and functional capacity and the extent to which it affects the daily life of the individual is important. Furthermore, it is also considered that this project may provide valuable insight into how important it is to follow up the development of children with lower urinary tract dysfunction. The hypotheses of this study are as follows; Hypotheses: H1: Children with lower urinary tract dysfunction have poor pelvic floor muscle activity compared to healthy children. H2: Children with lower urinary tract dysfunction have lower respiratory function than healthy children. H3: Children with lower urinary tract dysfunction have lower respiratory muscle strength than healthy children. H4: Children with lower urinary tract dysfunction have lower functional capacity than healthy children.

Conditions

Lower Urinary Tract Disorder

Keywords

Lower Urinary Tract Disorder; Pelvic floor; Pulmonary Function; Respiratory muscle strength; Functional capacity; Children

Outcome Measures

Primary Outcomes (7)

• Measurement of pelvic floor muscle activity

  Electromyography (EMG) is a well-known noninvasive and practical method to measure pelvic floor muscle activity. Before the measurement, participants will be asked to urinate so that no urine remains in the bladder. The evaluator will position the participant in a supine position with the legs supported from underneath, knees flexed at 140 degrees, soles of the feet in contact with the bed, and thighs and feet approximately 30 centimeters apart. Participants will be taught to isolated contraction and relaxation of the pelvic floor muscles without using auxiliary muscles by palpation of the anus before EMG evaluation. Two superficial electrodes will then be placed bilaterally adjacent to the mucocutaneous line of the anus at the 2 and 7 o'clock positions. The reference electrode will be placed on the inner thigh. After proper placement of the electrodes, pelvic floor muscle activity will be measured. After rest, the participant will be asked to perform 5 consecutive seconds of maximal

  Day 1

• Evaluation of pulmonary function-FVC%

  Pulmonary Function Test will be performed with COSMED Pony FX (COSMED; Italy) spirometer in accordance with ATS/ERS criteria. Forced vital capacity (FVC) will be measured and expressed as percentage of predicted value.

  Day 1

• Evaluation of pulmonary function-FEV1%

  Pulmonary Function Test will be performed with COSMED Pony FX (COSMED; Italy) spirometer in accordance with ATS/ERS criteria. Forced expiratory volume in 1st second (FEV1) will be measured and expressed as percentage of predicted value.

  Day 1

• Evaluation of pulmonary function-FEV1/FVC%

  Pulmonary Function Test will be performed with COSMED Pony FX (COSMED; Italy) spirometer in accordance with ATS/ERS criteria. Forced Vital Capacity/Forced expiratory volume in 1st second (FEV1/FVC) will be measured and expressed as percentage of predicted value.

  Day 1

• Evaluation of pulmonary function-PEF%

  Pulmonary Function Test will be performed with COSMED Pony FX (COSMED; Italy) spirometer in accordance with ATS/ERS criteria. Peak Expiratory Flow (PEF) will be measured and expressed as percentage of predicted value.

  Day 1

• Evaluation of pulmonary function- FEF25%-75%

  Pulmonary Function Test will be performed with COSMED Pony FX (COSMED; Italy) spirometer in accordance with ATS/ERS criteria. The mean expired flow in the middle half of the FVC (FEF25%-75%) will be measured and expressed as percentage of predicted value.

  Day 1

• Evaluation of respiratory muscle strength

  Respiratory muscle strength will be measured with a portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical; UK) according to ATS/ERS criteria. Pressures will be assessed by measuring maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) during several seconds of maximal inspiration (Müller maneuver) and expiration (Valsalva maneuver) through the mouth.

  Day 1

Secondary Outcomes (5)

• Evaluation of core muscle endurance-Trunk flexion test

  Day 1

• Evaluation of core muscle endurance-Trunk extension test

  Day 1

• Evaluation of core muscle endurance-Horizantal plank test

  Day 1

• Evaluation of core muscle endurance-Side plank test

  Day 1

• Evaluation of functional capacity

  Day 1

Study Arms (2)

Study Group

Children with lower urinary tract dysfunction

Control Group

Healthy peers

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The population of the study will consist of 14 volunteer subjects aged 6-18 years who are followed up by Bezmialem Vakıf University Faculty of Medicine, Department of Pediatric Urology with lower urinary tract dysfunction and 14 healthy controls in the same age group. All subjects will be evaluated and tested at Bezmialem Vakif University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation.

You may qualify if:

• Healthy lower urinary system without any dysfunction
• Being between the ages of 6-18
• Volunteering to participate in the study
• Not participating in a pelvic floor physiotherapy program for the last 6 months
• No intellectual and/or cognitive disability that would prevent participation in assessment and treatment

You may not qualify if:

• Having a disease related to the respiratory system
• Having a disease related to the musculoskeletal or neurological system
• History of abdominal, pelvic or spinal surgery

Sponsors & Collaborators

• Bezmialem Vakif University: lead
• Health Institutes of Turkey: collaborator

Study Sites (1)

Bezmialem Vakif University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Istanbul, Istanbul, 34050, Turkey (Türkiye)

Location

Related Publications (1)

• Tuncer D, Arslanturk-Yildirim A, Yuvakgil EN, Ozturk H. Evaluation of pelvic floor muscle activity, pulmonary function, respiratory muscle strength, core muscle endurance, and functional capacity in children with lower urinary tract dysfunction. J Pediatr Urol. 2025 Dec;21(6):1543-1550. doi: 10.1016/j.jpurol.2025.08.027. Epub 2025 Aug 30.

  PMID: 40935681 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 22, 2024
• Study Start: October 25, 2024
• Primary Completion: February 25, 2025
• Study Completion: March 1, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-05

Locations

TU (1)