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

NCT ID: NCT06728540

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-15
• Study Completion Date: 2025-08-20

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Children with Lower Urinary Tract Dysfunction (Study Group)

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Healthy Children (Control Group)

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.

Group Type: OTHER

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role: collaborator

Seda Yakit Yesilyurt

OTHER

Sponsor Role: lead

Responsible Party

Seda Yakit Yesilyurt

Assist.prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Izmir University of Economics

Izmir, İzmir, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

SYY_İEU_3

Identifier Type: -

Identifier Source: org_study_id