Connective Tissue Manipulation on Pelvic Floor Muscle Functions in Children

NCT ID: NCT05824429

Last Updated: 2024-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-05

Study Completion Date

2023-08-01

Brief Summary

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Lower urinary tract dysfunction (LUTD) is a disease group with subgroups that make up 40% of the patients were admitted to the pediatric urology clinic. The treatment of LUTD includes pharmacological, surgical treatment, neuromodulation, urotherapy, and pelvic floor muscle training. Conservative methods include bladder training, changing lifestyle and eating habits, pharmacological treatment, and physiotherapy approaches.

Physiotherapy approaches used in the treatment of LUTD are; biofeedback, electrical stimulation applications, diaphragm breathing exercises, and manual therapy methods.

The aim of our study is to compare the effects of Connective Tissue Manipülation (CTM) , which will be applied in addition to Pelvic Floor Muscle Rehabilitation (PFMR) for 8 weeks, on LUTD symptoms, pelvic floor muscle functions, uroflowmetry values and quality of life compared to PTMR applied alone for 8 weeks in children with LUTD.

Detailed Description

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LUTD is clinical without any neuropathy; It refers to conditions that occur with symptoms such as urinary incontinence, urgency, increased or decreased urination during the day, dysuria, difficulty in starting to void, and the feeling of not being able to empty the bladder adequately.

Pelvic floor muscles (PFM) are known to be involved in the pathophysiology of LUTD. PFM needs to function normally during both the storage and voiding phase. In the literature, there are studies with positive results using PFM exercises in the treatment of symptoms in children with LUTD.

Connective Tissue Manipulation (CTM) can also be used within the scope of physiotherapy approaches that can be applied in children with LUTD. CTM is a reflex treatment technique that is applied manually by physiotherapists to the skin area and acts on some cells and connective tissue by making short and long pulls. Although the mechanism of action of CTM has not been fully elucidated, it is known to reduce organ dysfunctions by maintaining the balance between the parasympathetic and sympathetic components of the autonomic nervous system through segmental and supra-segmental cutaneous reflex pathways.

We think that CTM applied in addition to PFMR in the pediatric population can reduce LUTD symptoms by restoring the autonomic nervous system balance and increasing vascularity in the bladder. Therefore, the aim of our study is to compare the effects of CTM, which will be applied in addition to PFMR in children with LUTD, on LUTD symptoms, pelvic floor muscle functions, uroflowmetry values, and quality of life compared to PTCR applied alone.

Conditions

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Lower Urinary Tract Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Connective Tissue Manipulation Group

Urotheraphy Diaphragmatic Breathing Exercises Pelvic Floor Muscle Exercise Connective Tissue Manipülation

Group Type EXPERIMENTAL

Urotherapy

Intervention Type OTHER

Urotherapy is an umbrella term that includes components such as information about bladder function and problem, lifestyle changes including the regulation of voiding and fluid intake times, correct toilet positions, information about bladder irritants, and motivation. All participants included in our study will be given urotherapy training before starting PFM exercises and CTM with their families.

Diaphragmatic Breathing Exercises

Intervention Type OTHER

In our research, diaphragm breathing exercises will be applied to both groups before starting PFM exercises in sessions for 8 weeks, 3 days a week.

PFM Exercises

Intervention Type OTHER

PFM exercises will be started after children learn to contract and relax their PFM in isolation without the use of auxiliary muscles. In the exercises, fast and slow contractions targeting type 1 and type 2 muscle fibers will be taught to increase both strength and endurance of PFM.

Connective Tissue Manipulation

Intervention Type OTHER

CTM is a reflex treatment technique that is applied manually by physiotherapists to the skin area and acts on some cells and connective tissue by making short and long pulls (. In our study, CTM will be applied to our study group, where CTM and PFMR will be applied together, 3 days a week, for a total of 8 weeks.

The application will be made to the basic region (sacral), lower thoracic, abdominal and anterior pelvic region.

Control Group

Urotheraphy Diaphragmatic Breathing Exercises Pelvic Floor Muscle Exercise

Group Type ACTIVE_COMPARATOR

Urotherapy

Intervention Type OTHER

Urotherapy is an umbrella term that includes components such as information about bladder function and problem, lifestyle changes including the regulation of voiding and fluid intake times, correct toilet positions, information about bladder irritants, and motivation. All participants included in our study will be given urotherapy training before starting PFM exercises and CTM with their families.

Diaphragmatic Breathing Exercises

Intervention Type OTHER

In our research, diaphragm breathing exercises will be applied to both groups before starting PFM exercises in sessions for 8 weeks, 3 days a week.

PFM Exercises

Intervention Type OTHER

PFM exercises will be started after children learn to contract and relax their PFM in isolation without the use of auxiliary muscles. In the exercises, fast and slow contractions targeting type 1 and type 2 muscle fibers will be taught to increase both strength and endurance of PFM.

Interventions

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Urotherapy

Urotherapy is an umbrella term that includes components such as information about bladder function and problem, lifestyle changes including the regulation of voiding and fluid intake times, correct toilet positions, information about bladder irritants, and motivation. All participants included in our study will be given urotherapy training before starting PFM exercises and CTM with their families.

Intervention Type OTHER

Diaphragmatic Breathing Exercises

In our research, diaphragm breathing exercises will be applied to both groups before starting PFM exercises in sessions for 8 weeks, 3 days a week.

Intervention Type OTHER

PFM Exercises

PFM exercises will be started after children learn to contract and relax their PFM in isolation without the use of auxiliary muscles. In the exercises, fast and slow contractions targeting type 1 and type 2 muscle fibers will be taught to increase both strength and endurance of PFM.

Intervention Type OTHER

Connective Tissue Manipulation

CTM is a reflex treatment technique that is applied manually by physiotherapists to the skin area and acts on some cells and connective tissue by making short and long pulls (. In our study, CTM will be applied to our study group, where CTM and PFMR will be applied together, 3 days a week, for a total of 8 weeks.

The application will be made to the basic region (sacral), lower thoracic, abdominal and anterior pelvic region.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Be in the age range of 5-15 years
* Diagnosed with LUTD by a pediatric urologist according to the criteria set by the ICCS
* Volunteering by parent and child to participate in the study

Exclusion Criteria

* Having any problems of neurogenic origin
* Any condition that affects the ability of the parent or child to respond to the scales to be used (mental retardation, cognitive problems, etc.)
* Malformations or anatomical differences in the urinary system
* Participants who discontinued treatment
* Presence of a urological surgery history
* Being on medication
* Having constipation and/or fecal incontinence
Minimum Eligible Age

5 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tugtepe Pediatric Urology Clinic

OTHER

Sponsor Role collaborator

Yeditepe University

OTHER

Sponsor Role lead

Responsible Party

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Melis ünal

Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Halil Tuğtepe, Prof Dr

Role: STUDY_CHAIR

Tugtepe Pediatric Urology Center

Melis Ünal, PT

Role: STUDY_DIRECTOR

Tugtepe Pediatric Urology Center

Locations

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Yeditepe University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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MelisU

Identifier Type: -

Identifier Source: org_study_id

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