Respiratory and Pelvic Floor Muscle Functions of Children With Lower Urinary Tract Dysfunction

NCT06728540 | Completed

• 1 other identifier: SYY_İEU_3
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

Lower urinary tract dysfunctions (LUTD) are disorders that can occur in the storage and voiding stages of bladder function other than neurological disease or lower urinary tract obstruction. Storage symptoms are increased or decreased voiding frequency, urinary incontinence, urgency and nocturia, while voiding symptoms are classified as hesitation, straining, weak stream and intermittent voiding. Other symptoms are holding maneuvers, feeling of incomplete voiding, post-voiding dripping, genital and lower urinary tract pain. Epidemiological studies show that the prevalence of LUTD is high in school-aged children, with rates as high as 22%. Very little is known about pelvic floor muscle training in children. Relaxation in the pelvic floor muscles is very important for the continuity of micturition and defecation functions. Respiratory function is one of the key elements in the relaxation of the pelvic floor. The relationship of the pelvic floor muscles with the diaphragm and their role in intra-abdominal pressure regulation have been demonstrated by many studies. In the adult population, it has been emphasized that the respiratory pattern should be corrected in pelvic floor dysfunctions and pelvic floor muscle training should be provided in those with respiratory problems. In the literature, rehabilitation programs for children with LUTD are treatment approaches in which respiratory and pelvic floor muscle training are applied together, but it has not been clearly stated which isolated approach is responsible for the resulting effect. In addition, these studies have emphasized that diaphragmatic exercises reduce or improve symptoms through the relaxation mechanism they create in the abdominal wall. However, unlike the literature, one of the aims of this study is to reveal the relationship between inspiratory and expiratory muscle strength and LUTD.

Conditions

Pelvic Floor Disorders; Lower Urinary Tract Symptoms; Physical Activity

Keywords

Pelvic Floor Disorders,; Lower Urinary Tract Dysfunction; Physical Activity

Outcome Measures

Primary Outcomes (2)

• Strength of Respiratory Muscle

  To measure respiratory muscle strength, maximal inspiratory pressure (MIP or PImax) and maximal expiratory pressure (MEP or PEmax) measurements will be used with a non-invasive, RP Check brand electronic pressure measuring device.

  baseline

• Level of Physical Activity

  Physical Activity Questionnaire for Children (PAQ-C):The physical activity levels of children will be assessed using the Physical Activity Questionnaire for Children (PAQ-C). The PAQ-C was developed in Canada to evaluate moderate to vigorous physical activity levels. It is based on the child's self-reported recall of the previous 7 days. The PAQ-C consists of 10 items, with 9 items used to calculate the activity score. The first question includes a list of 22 commonly performed activities. Responses to this question are evaluated on a 5-point scale (1 = never, 5 = 7 times or more). An average score is calculated, with higher scores indicating higher levels of physical activity.

  baseline

Secondary Outcomes (3)

• Voiding Disorders

  baseline

• Bladder and Bowel Dysfunction

  baseline

• Functions of Pelvic Floor Muscle

  baseline

Study Arms (2)

Children with Lower Urinary Tract Dysfunction (Study Group)

EXPERIMENTAL

Children included in the study will be evaluated only once. The sociodemographic and clinical characteristics of the children participating in the study will be evaluated with the evaluation form, respiratory muscle strength with the RP Check brand electronic pressure measurement device, and body composition with the Tanita MC-580 brand bioelectrical impedance analyzer. Pelvic floor muscle functions of children with LUTD will be evaluated with the 632 Myomed biofeedback device. The survey questions and the evaluation form will be filled out by the parents.

Other: Investigation of Physical Activity Levels, Respiratory and Pelvic Floor Muscle Function

Healthy Children (Control Group)

OTHER

Children included in the study will be evaluated only once. The sociodemographic and clinical characteristics of the children participating in the study will be evaluated with the evaluation form, respiratory muscle strength with the RP Check brand electronic pressure measurement device, and body composition with the Tanita MC-580 brand bioelectrical impedance analyzer. Pelvic floor muscle functions of children with LUTD will be evaluated with the 632 Myomed biofeedback device. The survey questions and the evaluation form will be filled out by the parents.

Other: Investigation of Physical Activity Levels, Respiratory and Pelvic Floor Muscle Function

Interventions

Investigation of Physical Activity Levels, Respiratory and Pelvic Floor Muscle Function OTHER

The sociodemographic and clinical characteristics of the children participating in the study will be evaluated with an evaluation form, respiratory muscle strength with an RP Check brand electronic pressure measurement device, and body composition with a Tanita MC-580 brand bioelectrical impedance analyzer. Pelvic floor muscle functions of children with LUTD will be evaluated with a 632 Myomed biofeedback device. The survey questions and the evaluation form will be filled out by the parents.

Children with Lower Urinary Tract Dysfunction (Study Group); Healthy Children (Control Group)

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosed with LUTD,
• Nighttime enuresis at least twice a week for at least 3 consecutive months.
• Daytime enuresis at least once a month for at least 3 consecutive months.
• Girls aged 6-14,
• who consent to participate in the study with the consent of their mother and father or legal guardian (legal representative) will be included in the study.
• Girls aged 6-14,
• who consent to participate in the study with the consent of their mother and father or legal guardian (legal representative) will be included in the study.

You may not qualify if:

• Children under 6 years of age,
• Anatomical changes in the urinary system,
• Spina bifida,
• History of active urinary tract infection,
• Neurological disease,
• An accompanying respiratory system disease (asthma and a history of frequent upper respiratory tract infections),
• Cognitive impairment,
• Mental retardation,
• Chronic kidney disease,
• Who have previously undergone orthopedic surgery will not be included in the study.

Sponsors & Collaborators

• Seda Yakit Yesilyurt: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Izmir University of Economics

Izmir, İzmir, 35330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pelvic Floor Disorders; Lower Urinary Tract Symptoms; Motor Activity

Interventions

Respiratory Rate

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assist.prof.

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: December 11, 2024
• Study Start: December 15, 2024
• Primary Completion: August 20, 2025
• Study Completion: August 20, 2025
• Last Updated: August 29, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)